{
    "info": {
        "nct_id": "NCT05487391",
        "official_title": "QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomized, Double-blind, Multicenter Phase III Clinical Study.",
        "inclusion_criteria": "* Subjects voluntarily participated, signed an informed consent form (ICF), and were able to follow the study procedures.\n* Histopathologically confirmed squamous or non-squamous non-small cell lung cancer\n* Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC) , and had received radical surgical resection (R0) treatment.\n* Participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days) and had to recover sufficiently from surgery.\n* Non-squamous NSCLC subjects without EGFR-sensitizing mutation or ALK fusion gene.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Subjects (including women and men) agreed to use effective contraception from the time of signing the informed consent to 180 days after the last use of the study drug.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Currently participating in and receiving study treatment or participating in an investigational drug study and receiving study treatment or using an investigational device within 4 weeks prior to the first dose of study treatment.\n* Previous treatment with neoadjuvant/adjuvant chemotherapy or immune checkpoint inhibitor therapy.\n* Cardiovascular and cerebrovascular diseases with clinical significance.\n* Gastrointestinal disease of clinical significance.\n* Clinically significant lung damage.\n* Human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive.\n* Active uncontrolled hepatitis B or active hepatitis C.\n* Administer a live vaccine within 30 days prior to the first dose of study treatment.\n* Other malignancies occurred within 5 years prior to study enrollment. (Except: Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in situ.)\n* Previously allergic to macromolecular protein preparations, or to any component of QL1706 and other investigational drugs; history of severe allergy to chemotherapy drugs (pemetrexed, vinorelbine, paclitaxel, cisplatin, carboplatin) or their preventive drugs, etc.\n* History of psychotropic substance abuse, alcohol or drug abuse; prior history of clear neurological or psychiatric disorders, including epilepsy or dementia.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subjects voluntarily participated, signed an informed consent form (ICF), and were able to follow the study procedures.",
            "criterions": [
                {
                    "exact_snippets": "Subjects voluntarily participated",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signed an informed consent form (ICF)",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to follow the study procedures",
                    "criterion": "ability to follow study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histopathologically confirmed squamous or non-squamous non-small cell lung cancer",
            "criterions": [
                {
                    "exact_snippets": "Histopathologically confirmed squamous or non-squamous non-small cell lung cancer",
                    "criterion": "squamous or non-squamous non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histopathologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC) , and had received radical surgical resection (R0) treatment.",
            "criterions": [
                {
                    "exact_snippets": "Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC)",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "IIIA",
                                "IIIB"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "had received radical surgical resection (R0) treatment",
                    "criterion": "surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "radical surgical resection (R0)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days) and had to recover sufficiently from surgery.",
            "criterions": [
                {
                    "exact_snippets": "Participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days)",
                    "criterion": "adjuvant therapy timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "had to recover sufficiently from surgery",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": "sufficient"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-squamous NSCLC subjects without EGFR-sensitizing mutation or ALK fusion gene.",
            "criterions": [
                {
                    "exact_snippets": "Non-squamous NSCLC subjects",
                    "criterion": "NSCLC type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-squamous"
                        }
                    ]
                },
                {
                    "exact_snippets": "without EGFR-sensitizing mutation",
                    "criterion": "EGFR-sensitizing mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without ... ALK fusion gene",
                    "criterion": "ALK fusion gene",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects (including women and men) agreed to use effective contraception from the time of signing the informed consent to 180 days after the last use of the study drug.",
            "criterions": [
                {
                    "exact_snippets": "Subjects (including women and men) agreed to use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from the time of signing the informed consent to 180 days after the last use of the study drug"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Currently participating in and receiving study treatment or participating in an investigational drug study and receiving study treatment or using an investigational device within 4 weeks prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Currently participating in and receiving study treatment",
                    "criterion": "current study treatment participation",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participating in an investigational drug study and receiving study treatment",
                    "criterion": "investigational drug study participation",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "using an investigational device within 4 weeks prior to the first dose of study treatment",
                    "criterion": "investigational device usage",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous treatment with neoadjuvant/adjuvant chemotherapy or immune checkpoint inhibitor therapy.",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with neoadjuvant/adjuvant chemotherapy",
                    "criterion": "previous neoadjuvant/adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous treatment with ... immune checkpoint inhibitor therapy",
                    "criterion": "previous immune checkpoint inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiovascular and cerebrovascular diseases with clinical significance.",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular ... diseases with clinical significance.",
                    "criterion": "cardiovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular diseases with clinical significance.",
                    "criterion": "cerebrovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gastrointestinal disease of clinical significance.",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal disease of clinical significance.",
                    "criterion": "gastrointestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinical significance"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant lung damage.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant lung damage",
                    "criterion": "lung damage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive.",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV) antibody positive",
                    "criterion": "HIV antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Treponema pallidum antibody positive",
                    "criterion": "Treponema pallidum antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active uncontrolled hepatitis B or active hepatitis C.",
            "criterions": [
                {
                    "exact_snippets": "Active uncontrolled hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "active uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Administer a live vaccine within 30 days prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Administer a live vaccine within 30 days prior to the first dose of study treatment.",
                    "criterion": "live vaccine administration",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other malignancies occurred within 5 years prior to study enrollment. (Except: Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in situ.)",
            "criterions": [
                {
                    "exact_snippets": "Other malignancies occurred within 5 years prior to study enrollment.",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Except: Bowen's disease",
                    "criterion": "Bowen's disease",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cured basal cell or squamous cell skin cancer",
                    "criterion": "cured basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate cancer with a Gleason score of 6",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "Gleason score",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated cervical carcinoma in situ",
                    "criterion": "treated cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously allergic to macromolecular protein preparations, or to any component of QL1706 and other investigational drugs; history of severe allergy to chemotherapy drugs (pemetrexed, vinorelbine, paclitaxel, cisplatin, carboplatin) or their preventive drugs, etc.",
            "criterions": [
                {
                    "exact_snippets": "Previously allergic to macromolecular protein preparations",
                    "criterion": "allergy to macromolecular protein preparations",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic ... to any component of QL1706",
                    "criterion": "allergy to QL1706 components",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic ... to ... other investigational drugs",
                    "criterion": "allergy to investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of severe allergy to chemotherapy drugs (pemetrexed, vinorelbine, paclitaxel, cisplatin, carboplatin)",
                    "criterion": "severe allergy to chemotherapy drugs",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe allergy to ... their preventive drugs",
                    "criterion": "severe allergy to preventive drugs for chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of psychotropic substance abuse, alcohol or drug abuse; prior history of clear neurological or psychiatric disorders, including epilepsy or dementia.",
            "criterions": [
                {
                    "exact_snippets": "History of psychotropic substance abuse",
                    "criterion": "psychotropic substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "alcohol or drug abuse",
                    "criterion": "alcohol or drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior history of clear neurological or psychiatric disorders",
                    "criterion": "neurological or psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including epilepsy",
                    "criterion": "epilepsy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including ... dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}