{
    "info": {
        "nct_id": "NCT05116462",
        "official_title": "A Randomized, Double-blind, Phase 3 Study of the Efficacy and Safety of Sindilizumab Combined With Chemotherapy or Placebo Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer (ORIENT-99)",
        "inclusion_criteria": "1. Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol.\n2. Age ≥ 18 years.\n3. Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma).\n4. Subjects with Stage II, IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8).\n5. Deemed radically resectable with curative intent.\n6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n7. Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Subjects with confirmed or suspected brain metastases.\n2. Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization.\n3. Received Chinese herbal medicine, Chinese traditional medicine with anti-tumor indications, or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within two weeks prior to randomization\n4. Received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study).\n5. Requiring long term systemic corticosteroids\n6. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known active syphilis.\n7. Active hepatitis B.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must sign the written informed consent form (ICF)",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be able to follow the visits and relevant procedures specified in the protocol",
                    "criterion": "ability to follow protocol",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma).",
            "criterions": [
                {
                    "exact_snippets": "Cytologically or histologically confirmed primary NSCLC",
                    "criterion": "primary NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "cytologically",
                                "histologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subjects with Stage II, IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8).",
            "criterions": [
                {
                    "exact_snippets": "Stage II, IIIA or IIIB (resectable N2 only) disease",
                    "criterion": "lung cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage II",
                                "Stage IIIA",
                                "Stage IIIB (resectable N2 only)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "based on the 8th edition of the TNM staging classification for lung cancer",
                    "criterion": "TNM staging classification edition",
                    "requirements": [
                        {
                            "requirement_type": "edition",
                            "expected_value": "8th"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Deemed radically resectable with curative intent.",
            "criterions": [
                {
                    "exact_snippets": "Deemed radically resectable",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": "radically resectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "curative intent",
                    "criterion": "surgical intent",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.",
                    "criterion": "Eastern Cooperative Oncology Group Performance Status (ECOG PS)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC.",
            "criterions": [
                {
                    "exact_snippets": "Have not received any prior systemic anti-tumor therapy",
                    "criterion": "prior systemic anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Have not received any prior ... local radiotherapy for NSCLC",
                    "criterion": "prior local radiotherapy for NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Subjects with confirmed or suspected brain metastases.",
            "criterions": [
                {
                    "exact_snippets": "confirmed or suspected brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Currently participating in an interventional clinical study",
                    "criterion": "participation in interventional clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment with another study drug or study device within 4 weeks prior to randomization",
                    "criterion": "treatment with another study drug or study device",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Received Chinese herbal medicine, Chinese traditional medicine with anti-tumor indications, or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within two weeks prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "Received Chinese herbal medicine",
                    "criterion": "Chinese herbal medicine",
                    "requirements": [
                        {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... Chinese traditional medicine with anti-tumor indications",
                    "criterion": "Chinese traditional medicine with anti-tumor indications",
                    "requirements": [
                        {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... drugs with immunomodulatory effects (including thymosin, interferon, interleukin)",
                    "criterion": "drugs with immunomodulatory effects",
                    "requirements": [
                        {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within two weeks prior to randomization",
                    "criterion": "time since last treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study).",
            "criterions": [
                {
                    "exact_snippets": "Received a live attenuated vaccine 4 weeks prior to randomization",
                    "criterion": "live attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "planned to receive a live attenuated vaccine during the study",
                    "criterion": "live attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "planned administration during study",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Requiring long term systemic corticosteroids",
            "criterions": [
                {
                    "exact_snippets": "Requiring long term systemic corticosteroids",
                    "criterion": "systemic corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "long term"
                        },
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known active syphilis.",
            "criterions": [
                {
                    "exact_snippets": "Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known active syphilis",
                    "criterion": "active syphilis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Active hepatitis B.",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}