{
    "info": {
        "nct_id": "NCT04884282",
        "official_title": "A Multicenter, Phase II, Open Label, Randomized Trial Evaluating the Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED)",
        "inclusion_criteria": "1. Male and female patients willing and able to give written informed consent;\n2. Histological or cytological confirmed diagnosis of HLA-A2+ NSCLC with no evidence of EGFR mutations or ALK or ROS1 rearrangement;\n3. Evidence of disease progression at the end of at least 4 cycles of chemo-immunotherapy or 2 cycles of chemo-immunotherapy followed by 2 cycles of immunotherapy (CheckMate9LA regimen) and eligible for treatment with docetaxel. This criterion implies that patients with immunotherapy primary resistance are excluded;\n4. Patients must have experienced progressive disease (PD), either during or within 3 months of discontinuing treatment with anti-PD-(L)1-based therapy, occurring after previous clear benefit (any complete -CR- or partial response -PR), or after previous stable disease (SD);\n5. Performance status 0-1 (ECOG);\n6. Patient compliance to trial procedures;\n7. Age ≥ 18 years;\n8. Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB > 9g/dl);\n9. Adequate liver function (bilirubin < G2, transaminases no more than 3xULN/<5xULN in present of liver metastases);\n10. Normal level of creatinine;\n11. Female patient: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [complete abstinence, intrauterine contraceptive device (IUD), birth control pills, or barrier device] until 5 months after end of treatment.\n\n    or Male patient: should practice complete abstinence or if sexually active with WOCBP must use any contraceptive method with failure rate less than 1%/year and they should not donate semen as follows: in arm A and C until 6 months since the last dose of docetaxel; in arm B until 3 months since last dose of tedopi.\n12. Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to treatment. Subjects with symptomatic tumor lesions that may require palliative radiotherapy within 4 weeks of first treatment are strongly encouraged to receive palliative radiotherapy prior to treatment. Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization;\n13. Patients must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patient positive for actionable EGFR mutations or ALK or ROS1 rearrangement;\n2. No previous chemoimmunotherapy for metastatic disease or evidence of disease progression during the first 4 cycles of chemoimmunotherapy (primary resistance). Patients with adjuvant resistance (documented loco-regionally and/or systemic relapse of their disease occurring <6 months after the last dose of anti-PD-(L)1-based systemic adjuvant therapy) are excluded;\n3. Patients with intervening systemic therapy following prior anti-PD-(L)1-based therapy;\n4. Symptomatic brain metastases. Asymptomatic brain metastases are allowed if not requiring corticosteroids use at a dose >10mg daily prednisone (or equivalent);\n5. Diagnosis of any other malignancy during the last 3 years, except for in situ carcinoma of cervix uteri and cutaneous squamous cell carcinoma or other local tumors considered cured;\n6. Pregnancy or lactating;\n7. Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;\n8. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease;\n9. Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection;\n10. Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "8. Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB > 9g/dl);",
                "criterions": [
                    {
                        "exact_snippets": "Adequate BM function (ANC ≥ 1.5x109/L",
                        "criterion": "ANC",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate BM function ... Platelets ≥ 100x109/L",
                        "criterion": "Platelets",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate BM function ... HgB > 9g/dl",
                        "criterion": "HgB",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate BM function (ANC ≥ 1.5x109/L",
                        "criterion": "ANC",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate BM function ... Platelets ≥ 100x109/L",
                        "criterion": "Platelets",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate BM function ... HgB > 9g/dl",
                        "criterion": "HgB",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Adequate liver function (bilirubin < G2, transaminases no more than 3xULN/<5xULN in present of liver metastases);",
                "criterions": [
                    {
                        "exact_snippets": "Adequate liver function (bilirubin < G2",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "G"
                            }
                        }
                    },
                    {
                        "exact_snippets": "transaminases no more than 3xULN/<5xULN in present of liver metastases",
                        "criterion": "transaminase level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "ULN"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "transaminases no more than 3xULN/<5xULN in present of liver metastases",
                    "criterion": "liver metastases",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Adequate liver function (bilirubin < G2",
                            "criterion": "bilirubin level",
                            "requirement": {
                                "requirement_type": "severity",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 2,
                                    "unit": "G"
                                }
                            }
                        },
                        {
                            "exact_snippets": "transaminases no more than 3xULN/<5xULN in present of liver metastases",
                            "criterion": "transaminase level",
                            "requirement": {
                                "requirement_type": "quantity",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<=",
                                            "value": 3,
                                            "unit": "ULN"
                                        },
                                        {
                                            "operator": "<",
                                            "value": 5,
                                            "unit": "ULN"
                                        }
                                    ]
                                }
                            }
                        }
                    ]
                },
                "else_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Adequate liver function (bilirubin < G2",
                            "criterion": "bilirubin level",
                            "requirement": {
                                "requirement_type": "severity",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 2,
                                    "unit": "G"
                                }
                            }
                        },
                        {
                            "exact_snippets": "transaminases no more than 3xULN/<5xULN in present of liver metastases",
                            "criterion": "transaminase level",
                            "requirement": {
                                "requirement_type": "quantity",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 3,
                                    "unit": "ULN"
                                }
                            }
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "10. Normal level of creatinine;",
                "criterions": [
                    {
                        "exact_snippets": "Normal level of creatinine",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Normal level of creatinine",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Female patient: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [complete abstinence, intrauterine contraceptive device (IUD), birth control pills, or barrier device] until 5 months after end of treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Female patient",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "childbearing potential either terminated by surgery, radiation, or menopause",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "termination",
                            "expected_value": [
                                "surgery",
                                "radiation",
                                "menopause"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "attenuated by use of approved contraceptive method [complete abstinence, intrauterine contraceptive device (IUD), birth control pills, or barrier device]",
                        "criterion": "contraceptive method",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": [
                                "complete abstinence",
                                "intrauterine contraceptive device (IUD)",
                                "birth control pills",
                                "barrier device"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "until 5 months after end of treatment",
                        "criterion": "duration of contraceptive use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Female patient",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": "female"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "childbearing potential either terminated by surgery, radiation, or menopause",
                                        "criterion": "childbearing potential",
                                        "requirement": {
                                            "requirement_type": "termination",
                                            "expected_value": [
                                                "surgery",
                                                "radiation",
                                                "menopause"
                                            ]
                                        }
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "attenuated by use of approved contraceptive method [complete abstinence, intrauterine contraceptive device (IUD), birth control pills, or barrier device]",
                                                "criterion": "contraceptive method",
                                                "requirement": {
                                                    "requirement_type": "use",
                                                    "expected_value": [
                                                        "complete abstinence",
                                                        "intrauterine contraceptive device (IUD)",
                                                        "birth control pills",
                                                        "barrier device"
                                                    ]
                                                }
                                            },
                                            {
                                                "exact_snippets": "until 5 months after end of treatment",
                                                "criterion": "duration of contraceptive use",
                                                "requirement": {
                                                    "requirement_type": "duration",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 5,
                                                        "unit": "months"
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "or Male patient: should practice complete abstinence or if sexually active with WOCBP must use any contraceptive method with failure rate less than 1%/year and they should not donate semen as follows: in arm A and C until 6 months since the last dose of docetaxel; in arm B until 3 months since last dose of tedopi.",
                "criterions": [
                    {
                        "exact_snippets": "Male patient",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "should practice complete abstinence",
                        "criterion": "sexual activity",
                        "requirement": {
                            "requirement_type": "practice",
                            "expected_value": "complete abstinence"
                        }
                    },
                    {
                        "exact_snippets": "if sexually active with WOCBP must use any contraceptive method with failure rate less than 1%/year",
                        "criterion": "contraceptive method",
                        "requirement": {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "%/year"
                            }
                        }
                    },
                    {
                        "exact_snippets": "they should not donate semen",
                        "criterion": "semen donation",
                        "requirement": {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "in arm A and C until 6 months since the last dose of docetaxel",
                        "criterion": "semen donation restriction duration for arm A and C",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "in arm B until 3 months since last dose of tedopi",
                        "criterion": "semen donation restriction duration for arm B",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Male patient",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": "male"
                                }
                            },
                            {
                                "exact_snippets": "should practice complete abstinence",
                                "criterion": "sexual activity",
                                "requirement": {
                                    "requirement_type": "practice",
                                    "expected_value": "complete abstinence"
                                }
                            },
                            {
                                "exact_snippets": "they should not donate semen",
                                "criterion": "semen donation",
                                "requirement": {
                                    "requirement_type": "prohibition",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "in arm A and C until 6 months since the last dose of docetaxel",
                                        "criterion": "semen donation restriction duration for arm A and C",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "in arm B until 3 months since last dose of tedopi",
                                        "criterion": "semen donation restriction duration for arm B",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "=",
                                                "value": 3,
                                                "unit": "months"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Male patient",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": "male"
                                }
                            },
                            {
                                "exact_snippets": "if sexually active with WOCBP must use any contraceptive method with failure rate less than 1%/year",
                                "criterion": "contraceptive method",
                                "requirement": {
                                    "requirement_type": "failure rate",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 1,
                                        "unit": "%/year"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "they should not donate semen",
                                "criterion": "semen donation",
                                "requirement": {
                                    "requirement_type": "prohibition",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "in arm A and C until 6 months since the last dose of docetaxel",
                                        "criterion": "semen donation restriction duration for arm A and C",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "in arm B until 3 months since last dose of tedopi",
                                        "criterion": "semen donation restriction duration for arm B",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "=",
                                                "value": 3,
                                                "unit": "months"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Patients must have experienced progressive disease (PD), either during or within 3 months of discontinuing treatment with anti-PD-(L)1-based therapy, occurring after previous clear benefit (any complete -CR- or partial response -PR), or after previous stable disease (SD);",
                "criterions": [
                    {
                        "exact_snippets": "Patients must have experienced progressive disease (PD)",
                        "criterion": "progressive disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "either during or within 3 months of discontinuing treatment with anti-PD-(L)1-based therapy",
                        "criterion": "timing of progressive disease",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "during or within 3 months of discontinuing anti-PD-(L)1-based therapy"
                        }
                    },
                    {
                        "exact_snippets": "occurring after previous clear benefit (any complete -CR- or partial response -PR-)",
                        "criterion": "previous treatment response",
                        "requirement": {
                            "requirement_type": "response type",
                            "expected_value": [
                                "complete response",
                                "partial response"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "or after previous stable disease (SD)",
                        "criterion": "previous treatment response",
                        "requirement": {
                            "requirement_type": "response type",
                            "expected_value": "stable disease"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients must have experienced progressive disease (PD)",
                                "criterion": "progressive disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "either during or within 3 months of discontinuing treatment with anti-PD-(L)1-based therapy",
                                "criterion": "timing of progressive disease",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "during or within 3 months of discontinuing anti-PD-(L)1-based therapy"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "occurring after previous clear benefit (any complete -CR- or partial response -PR-)",
                                "criterion": "previous treatment response",
                                "requirement": {
                                    "requirement_type": "response type",
                                    "expected_value": [
                                        "complete response",
                                        "partial response"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "or after previous stable disease (SD)",
                                "criterion": "previous treatment response",
                                "requirement": {
                                    "requirement_type": "response type",
                                    "expected_value": "stable disease"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Patient positive for actionable EGFR mutations or ALK or ROS1 rearrangement;",
                "criterions": [
                    {
                        "exact_snippets": "Patient positive for actionable EGFR mutations",
                        "criterion": "EGFR mutations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient positive for ... ALK ... rearrangement",
                        "criterion": "ALK rearrangement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient positive for ... ROS1 rearrangement",
                        "criterion": "ROS1 rearrangement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Patient positive for actionable EGFR mutations",
                        "criterion": "EGFR mutations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient positive for ... ALK ... rearrangement",
                        "criterion": "ALK rearrangement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient positive for ... ROS1 rearrangement",
                        "criterion": "ROS1 rearrangement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. No previous chemoimmunotherapy for metastatic disease or evidence of disease progression during the first 4 cycles of chemoimmunotherapy (primary resistance). Patients with adjuvant resistance (documented loco-regionally and/or systemic relapse of their disease occurring <6 months after the last dose of anti-PD-(L)1-based systemic adjuvant therapy) are excluded;",
                "criterions": [
                    {
                        "exact_snippets": "No previous chemoimmunotherapy for metastatic disease",
                        "criterion": "previous chemoimmunotherapy for metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "evidence of disease progression during the first 4 cycles of chemoimmunotherapy (primary resistance)",
                        "criterion": "disease progression during the first 4 cycles of chemoimmunotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients with adjuvant resistance (documented loco-regionally and/or systemic relapse of their disease occurring <6 months after the last dose of anti-PD-(L)1-based systemic adjuvant therapy) are excluded",
                        "criterion": "adjuvant resistance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No previous chemoimmunotherapy for metastatic disease",
                                "criterion": "previous chemoimmunotherapy for metastatic disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "evidence of disease progression during the first 4 cycles of chemoimmunotherapy (primary resistance)",
                                "criterion": "disease progression during the first 4 cycles of chemoimmunotherapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Patients with adjuvant resistance (documented loco-regionally and/or systemic relapse of their disease occurring <6 months after the last dose of anti-PD-(L)1-based systemic adjuvant therapy) are excluded",
                        "criterion": "adjuvant resistance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Patients with intervening systemic therapy following prior anti-PD-(L)1-based therapy;",
                "criterions": [
                    {
                        "exact_snippets": "intervening systemic therapy following prior anti-PD-(L)1-based therapy",
                        "criterion": "intervening systemic therapy",
                        "requirement": {
                            "requirement_type": "sequence",
                            "expected_value": "following prior anti-PD-(L)1-based therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "intervening systemic therapy following prior anti-PD-(L)1-based therapy",
                        "criterion": "intervening systemic therapy",
                        "requirement": {
                            "requirement_type": "sequence",
                            "expected_value": "following prior anti-PD-(L)1-based therapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Symptomatic brain metastases. Asymptomatic brain metastases are allowed if not requiring corticosteroids use at a dose >10mg daily prednisone (or equivalent);",
                "criterions": [
                    {
                        "exact_snippets": "Symptomatic brain metastases.",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Asymptomatic brain metastases ... not requiring corticosteroids use at a dose >10mg daily prednisone (or equivalent)",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Asymptomatic brain metastases ... not requiring corticosteroids use at a dose >10mg daily prednisone (or equivalent)",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "corticosteroids use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg daily prednisone (or equivalent)"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Symptomatic brain metastases.",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "symptomatic",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Asymptomatic brain metastases ... not requiring corticosteroids use at a dose >10mg daily prednisone (or equivalent)",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "symptomatic",
                                    "expected_value": false
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "Asymptomatic brain metastases ... not requiring corticosteroids use at a dose >10mg daily prednisone (or equivalent)",
                                    "criterion": "brain metastases",
                                    "requirement": {
                                        "requirement_type": "corticosteroids use",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 10,
                                            "unit": "mg daily prednisone (or equivalent)"
                                        }
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Diagnosis of any other malignancy during the last 3 years, except for in situ carcinoma of cervix uteri and cutaneous squamous cell carcinoma or other local tumors considered cured;",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis of any other malignancy during the last 3 years",
                        "criterion": "other malignancy diagnosis",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except for in situ carcinoma of cervix uteri",
                        "criterion": "in situ carcinoma of cervix uteri",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ... cutaneous squamous cell carcinoma",
                        "criterion": "cutaneous squamous cell carcinoma",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ... other local tumors considered cured",
                        "criterion": "other local tumors considered cured",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Diagnosis of any other malignancy during the last 3 years",
                                    "criterion": "other malignancy diagnosis",
                                    "requirement": {
                                        "requirement_type": "time frame",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 3,
                                            "unit": "years"
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "except for in situ carcinoma of cervix uteri",
                                        "criterion": "in situ carcinoma of cervix uteri",
                                        "requirement": {
                                            "requirement_type": "exclusion",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "except for ... cutaneous squamous cell carcinoma",
                                        "criterion": "cutaneous squamous cell carcinoma",
                                        "requirement": {
                                            "requirement_type": "exclusion",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "except for ... other local tumors considered cured",
                                        "criterion": "other local tumors considered cured",
                                        "requirement": {
                                            "requirement_type": "exclusion",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Pregnancy or lactating;",
                "criterions": [
                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;",
                "criterions": [
                    {
                        "exact_snippets": "Patients with an active, known or suspected autoimmune disease.",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients with type I diabetes mellitus;",
                        "criterion": "type I diabetes mellitus",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypothyroidism only requiring hormone replacement",
                        "criterion": "hypothyroidism",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "hormone replacement"
                        }
                    },
                    {
                        "exact_snippets": "skin disorders (such as vitiligo, psoriasis, or alopecia) requiring systemic treatment",
                        "criterion": "skin disorders",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "systemic treatment"
                        }
                    },
                    {
                        "exact_snippets": "conditions not expected to recur in the absence of an external trigger",
                        "criterion": "conditions not expected to recur",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients with an active, known or suspected autoimmune disease.",
                            "criterion": "autoimmune disease",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "or_criteria": [
                                {
                                    "exact_snippets": "Patients with type I diabetes mellitus;",
                                    "criterion": "type I diabetes mellitus",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "hypothyroidism only requiring hormone replacement",
                                    "criterion": "hypothyroidism",
                                    "requirement": {
                                        "requirement_type": "treatment",
                                        "expected_value": "hormone replacement"
                                    }
                                },
                                {
                                    "exact_snippets": "skin disorders (such as vitiligo, psoriasis, or alopecia) requiring systemic treatment",
                                    "criterion": "skin disorders",
                                    "requirement": {
                                        "requirement_type": "treatment",
                                        "expected_value": "systemic treatment"
                                    }
                                },
                                {
                                    "exact_snippets": "conditions not expected to recur in the absence of an external trigger",
                                    "criterion": "conditions not expected to recur",
                                    "requirement": {
                                        "requirement_type": "recurrence",
                                        "expected_value": false
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).",
                "criterions": [
                    {
                        "exact_snippets": "known history of testing positive for human immunodeficiency virus (HIV)",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "history of testing positive",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known acquired immunodeficiency syndrome (AIDS)",
                        "criterion": "AIDS status",
                        "requirement": {
                            "requirement_type": "known",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "known history of testing positive for human immunodeficiency virus (HIV)",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "history of testing positive",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known acquired immunodeficiency syndrome (AIDS)",
                        "criterion": "AIDS status",
                        "requirement": {
                            "requirement_type": "known",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "1. Male and female patients willing and able to give written informed consent;",
                "criterions": [
                    {
                        "exact_snippets": "Male and female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "willing and able to give written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing and able to give written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Histological or cytological confirmed diagnosis of HLA-A2+ NSCLC with no evidence of EGFR mutations or ALK or ROS1 rearrangement;",
                "criterions": [
                    {
                        "exact_snippets": "Histological or cytological confirmed diagnosis",
                        "criterion": "diagnosis confirmation method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "HLA-A2+ NSCLC",
                        "criterion": "HLA-A2 status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "HLA-A2+"
                        }
                    },
                    {
                        "exact_snippets": "HLA-A2+ NSCLC",
                        "criterion": "NSCLC diagnosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "no evidence of EGFR mutations",
                        "criterion": "EGFR mutations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "no evidence of ... ALK ... rearrangement",
                        "criterion": "ALK rearrangement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "no evidence of ... ROS1 rearrangement",
                        "criterion": "ROS1 rearrangement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Evidence of disease progression at the end of at least 4 cycles of chemo-immunotherapy or 2 cycles of chemo-immunotherapy followed by 2 cycles of immunotherapy (CheckMate9LA regimen) and eligible for treatment with docetaxel. This criterion implies that patients with immunotherapy primary resistance are excluded;",
                "criterions": [
                    {
                        "exact_snippets": "Evidence of disease progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "at the end of at least 4 cycles of chemo-immunotherapy",
                        "criterion": "chemo-immunotherapy cycles",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "cycles"
                            }
                        }
                    },
                    {
                        "exact_snippets": "2 cycles of chemo-immunotherapy followed by 2 cycles of immunotherapy (CheckMate9LA regimen)",
                        "criterion": "CheckMate9LA regimen",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "eligible for treatment with docetaxel",
                        "criterion": "eligibility for docetaxel treatment",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patients with immunotherapy primary resistance are excluded",
                        "criterion": "immunotherapy primary resistance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Performance status 0-1 (ECOG);",
                "criterions": [
                    {
                        "exact_snippets": "Performance status 0-1 (ECOG)",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "scale",
                            "expected_value": "ECOG"
                        }
                    },
                    {
                        "exact_snippets": "Performance status 0-1 (ECOG)",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Patient compliance to trial procedures;",
                "criterions": [
                    {
                        "exact_snippets": "Patient compliance to trial procedures",
                        "criterion": "patient compliance",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": "trial procedures"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Age ≥ 18 years;",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "12. Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to treatment. Subjects with symptomatic tumor lesions that may require palliative radiotherapy within 4 weeks of first treatment are strongly encouraged to receive palliative radiotherapy prior to treatment. Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization;",
                "criterions": [
                    {
                        "exact_snippets": "Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to treatment.",
                        "criterion": "prior palliative radiotherapy to non-CNS lesions",
                        "requirement": {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Subjects with symptomatic tumor lesions that may require palliative radiotherapy within 4 weeks of first treatment are strongly encouraged to receive palliative radiotherapy prior to treatment.",
                        "criterion": "symptomatic tumor lesions",
                        "requirement": {
                            "requirement_type": "palliative radiotherapy requirement",
                            "expected_value": "strongly encouraged if within 4 weeks of first treatment"
                        }
                    },
                    {
                        "exact_snippets": "Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization;",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "treatment adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization;",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "neurological status",
                            "expected_value": "returned to baseline"
                        }
                    },
                    {
                        "exact_snippets": "Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization;",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "time since neurological return to baseline",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to treatment.",
                                "criterion": "prior palliative radiotherapy to non-CNS lesions",
                                "requirement": {
                                    "requirement_type": "completion time",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization;",
                                        "criterion": "CNS metastases",
                                        "requirement": {
                                            "requirement_type": "treatment adequacy",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization;",
                                        "criterion": "CNS metastases",
                                        "requirement": {
                                            "requirement_type": "neurological status",
                                            "expected_value": "returned to baseline"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization;",
                                        "criterion": "CNS metastases",
                                        "requirement": {
                                            "requirement_type": "time since neurological return to baseline",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Patients must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization.",
                "criterions": [
                    {
                        "exact_snippets": "Patients must be either off corticosteroids",
                        "criterion": "corticosteroid use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent)",
                        "criterion": "corticosteroid dose",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable or decreasing"
                        }
                    },
                    {
                        "exact_snippets": "on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent)",
                        "criterion": "corticosteroid dose",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "for at least 2 weeks prior to randomization",
                        "criterion": "duration of corticosteroid dose",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "on a stable or decreasing dose of \u0010 mg daily prednisone (or equivalent)",
                                "criterion": "corticosteroid dose",
                                "requirement": {
                                    "requirement_type": "stability",
                                    "expected_value": "stable or decreasing"
                                }
                            },
                            {
                                "exact_snippets": "on a stable or decreasing dose of \u0010 mg daily prednisone (or equivalent)",
                                "criterion": "corticosteroid dose",
                                "requirement": {
                                    "requirement_type": "dose",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "mg"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "for at least 2 weeks prior to randomization",
                                "criterion": "duration of corticosteroid dose",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Patients must be either off corticosteroids",
                        "criterion": "corticosteroid use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "8. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease;",
                "criterions": [
                    {
                        "exact_snippets": "condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization",
                        "criterion": "systemic treatment with corticosteroids or immunosuppressive medications",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization",
                        "criterion": "systemic treatment with corticosteroids or immunosuppressive medications",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone equivalent"
                            }
                        }
                    },
                    {
                        "exact_snippets": "condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization",
                        "criterion": "systemic treatment with corticosteroids or immunosuppressive medications",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days of randomization"
                        }
                    },
                    {
                        "exact_snippets": "Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease",
                        "criterion": "use of inhaled or topical steroids, and adrenal replacement steroid",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone equivalent"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease",
                        "criterion": "use of inhaled or topical steroids, and adrenal replacement steroid",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "absence of active autoimmune disease"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection;",
                "criterions": [
                    {
                        "exact_snippets": "positive test for hepatitis B virus surface antigen (HBV sAg)",
                        "criterion": "hepatitis B virus surface antigen (HBV sAg)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "positive test for ... hepatitis C virus ribonucleic acid (HCV RNA)",
                        "criterion": "hepatitis C virus ribonucleic acid (HCV RNA)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "positive test for hepatitis B virus surface antigen (HBV sAg)",
                        "criterion": "hepatitis B virus surface antigen (HBV sAg)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive test for ... hepatitis C virus ribonucleic acid (HCV RNA)",
                        "criterion": "hepatitis C virus ribonucleic acid (HCV RNA)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}