{
    "info": {
        "nct_id": "NCT06250829",
        "official_title": "Analysis of Variables Predicting Pathological Complete Response and Immune Related Adverse Events in Patients With Resectable Non-Small Cell Lung Cancer Receiving Neoadjuvant Immunotherapy With Chemotherapy - A Prospective Cohort Study",
        "inclusion_criteria": "* 1. Participants with histologically confirmed Stage IB (≥ 4 cm), II, IIIA (N2) NSCLC (as per the 8th American Joint Committee on Cancer (AJCC)) who are considered to have resectable disease.\n\n  2. Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).\n\n  3. Participants must have tumor tissue available for PD-L1 immunohistochemical (IHC) testing.\n\n  4. Eastern Cooperative Group (ECOG) Performance Status 0-2. 5. Able to give informed consent.\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* 1. Presence of locally advanced, unresectable, or metastatic disease. 2. Participants with known EGFR mutations, ALK or ROS1 translocation. 3. Subjects with active, known, or suspected autoimmune disease (except subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment).\n\n  4. Subjects with a condition requiring systemic treatment with either corticosteroids (10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.\n\n  5. Subjects with previous malignancies are excluded unless a complete remission was achieved at least 5 years prior to study entry and no additional therapy is required or anticipated to be required during the study (non-melanoma skin cancer and other indolent malignancies not requiring any treatment and that are unlikely to affect blood-based biomarkers are allowed).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "2. Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Participants must have tumor tissue available for PD-L1 immunohistochemical (IHC) testing.",
                "criterions": [
                    {
                        "exact_snippets": "tumor tissue available",
                        "criterion": "tumor tissue",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PD-L1 immunohistochemical (IHC) testing",
                        "criterion": "PD-L1 immunohistochemical (IHC) testing",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "tumor tissue available",
                        "criterion": "tumor tissue",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PD-L1 immunohistochemical (IHC) testing",
                        "criterion": "PD-L1 immunohistochemical (IHC) testing",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Eastern Cooperative Group (ECOG) Performance Status 0-2. 5. Able to give informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Group (ECOG) Performance Status 0-2",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Able to give informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Group (ECOG) Performance Status 0-2",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Able to give informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "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"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* 1. Presence of locally advanced, unresectable, or metastatic disease. 2. Participants with known EGFR mutations, ALK or ROS1 translocation. 3. Subjects with active, known, or suspected autoimmune disease (except subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment).",
                "criterions": [
                    {
                        "exact_snippets": "Presence of locally advanced, unresectable, or metastatic disease.",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "locally advanced",
                                "unresectable",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Participants with known EGFR mutations, ALK or ROS1 translocation.",
                        "criterion": "genetic mutations or translocations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "EGFR mutations",
                                "ALK translocation",
                                "ROS1 translocation"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Subjects with active, known, or suspected autoimmune disease (except subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment).",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Subjects with active, known, or suspected autoimmune disease (except subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment).",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "type I diabetes mellitus",
                                "residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement",
                                "skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Presence of locally advanced, unresectable, or metastatic disease.",
                                "criterion": "disease stage",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "locally advanced",
                                        "unresectable",
                                        "metastatic"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Participants with known EGFR mutations, ALK or ROS1 translocation.",
                                "criterion": "genetic mutations or translocations",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "EGFR mutations",
                                        "ALK translocation",
                                        "ROS1 translocation"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Subjects with active, known, or suspected autoimmune disease (except subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment).",
                                "criterion": "autoimmune disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "Subjects with active, known, or suspected autoimmune disease (except subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment).",
                                    "criterion": "autoimmune disease",
                                    "requirement": {
                                        "requirement_type": "exceptions",
                                        "expected_value": [
                                            "type I diabetes mellitus",
                                            "residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement",
                                            "skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment"
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Subjects with a condition requiring systemic treatment with either corticosteroids (10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.",
                "criterions": [
                    {
                        "exact_snippets": "condition requiring systemic treatment with either corticosteroids (10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration",
                        "criterion": "systemic treatment with corticosteroids or immunosuppressive medications",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Inhaled or topical steroids are permitted in the absence of active autoimmune disease",
                        "criterion": "active autoimmune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "condition requiring systemic treatment with either corticosteroids (10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration",
                                    "criterion": "systemic treatment with corticosteroids or immunosuppressive medications",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "Inhaled or topical steroids are permitted in the absence of active autoimmune disease",
                                    "criterion": "active autoimmune disease",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            ]
                        },
                        "then_criteria": {
                            "exact_snippets": "condition requiring systemic treatment with either corticosteroids (10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration",
                            "criterion": "systemic treatment with corticosteroids or immunosuppressive medications",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        },
                        "else_criteria": null
                    },
                    {
                        "exact_snippets": "Inhaled or topical steroids are permitted in the absence of active autoimmune disease",
                        "criterion": "active autoimmune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Subjects with previous malignancies are excluded unless a complete remission was achieved at least 5 years prior to study entry and no additional therapy is required or anticipated to be required during the study (non-melanoma skin cancer and other indolent malignancies not requiring any treatment and that are unlikely to affect blood-based biomarkers are allowed).",
                "criterions": [
                    {
                        "exact_snippets": "previous malignancies are excluded unless a complete remission was achieved at least 5 years prior to study entry",
                        "criterion": "previous malignancies",
                        "requirement": {
                            "requirement_type": "remission duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "no additional therapy is required or anticipated to be required during the study",
                        "criterion": "additional therapy",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "non-melanoma skin cancer and other indolent malignancies not requiring any treatment and that are unlikely to affect blood-based biomarkers are allowed",
                        "criterion": "non-melanoma skin cancer and other indolent malignancies",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "non-melanoma skin cancer and other indolent malignancies not requiring any treatment and that are unlikely to affect blood-based biomarkers are allowed",
                        "criterion": "non-melanoma skin cancer and other indolent malignancies",
                        "requirement": {
                            "requirement_type": "impact on blood-based biomarkers",
                            "expected_value": "unlikely"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "not_criteria": {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "previous malignancies are excluded unless a complete remission was achieved at least 5 years prior to study entry",
                                                        "criterion": "previous malignancies",
                                                        "requirement": {
                                                            "requirement_type": "remission duration",
                                                            "expected_value": {
                                                                "operator": ">=",
                                                                "value": 5,
                                                                "unit": "years"
                                                            }
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "no additional therapy is required or anticipated to be required during the study",
                                                        "criterion": "additional therapy",
                                                        "requirement": {
                                                            "requirement_type": "requirement",
                                                            "expected_value": false
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    }
                                },
                                {
                                    "or_criteria": [
                                        {
                                            "and_criteria": [
                                                {
                                                    "exact_snippets": "non-melanoma skin cancer and other indolent malignancies not requiring any treatment and that are unlikely to affect blood-based biomarkers are allowed",
                                                    "criterion": "non-melanoma skin cancer and other indolent malignancies",
                                                    "requirement": {
                                                        "requirement_type": "treatment requirement",
                                                        "expected_value": false
                                                    }
                                                },
                                                {
                                                    "exact_snippets": "non-melanoma skin cancer and other indolent malignancies not requiring any treatment and that are unlikely to affect blood-based biomarkers are allowed",
                                                    "criterion": "non-melanoma skin cancer and other indolent malignancies",
                                                    "requirement": {
                                                        "requirement_type": "impact on blood-based biomarkers",
                                                        "expected_value": "unlikely"
                                                    }
                                                }
                                            ]
                                        }
                                    ]
                                }
                            ]
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* 1. Participants with histologically confirmed Stage IB (≥ 4 cm), II, IIIA (N2) NSCLC (as per the 8th American Joint Committee on Cancer (AJCC)) who are considered to have resectable disease.",
                "criterions": [
                    {
                        "exact_snippets": "histologically confirmed Stage IB (≥ 4 cm), II, IIIA (N2) NSCLC",
                        "criterion": "NSCLC stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage IB (≥ 4 cm)",
                                "Stage II",
                                "Stage IIIA (N2)"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "considered to have resectable disease",
                        "criterion": "resectable disease",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}