{
    "info": {
        "nct_id": "NCT06162572",
        "official_title": "A Phase 1b/2, Multicenter, Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) With High PD-L1 Expression",
        "inclusion_criteria": "* Adult patient aged ≥ 18 years\n* Written informed consent\n* Histologically (squamous or non-squamous) or cytologically documented locally advanced NSCLC not eligible for surgical resection and/or definitive chemoradiation, or metastatic NSCLC\n* No prior systemic treatment for locally advanced or metastatic NSCLC\n* High tumor cell PD-L1 expression [Tumor Proportion Score (TPS) ≥50%] based on documented status as determined by an approved test\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Measurable disease as determined by RECIST v1.1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g. EGFR mutation, ALK fusion oncogene, ROS1 aberrations)\n* Prior immune checkpoint inhibitor therapy\n* Active brain metastases\n* Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n* Uncontrolled HIV infection. Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are allowed to enroll\n* Active, known or suspected autoimmune disease or immune deficiency\n* History of hypersensitivity reactions to any ingredient of the investigational medicinal product (IMP) and other monoclonal antibody (mAbs) and/or their excipients\n* History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis ≥ grade 2\n* History of inflammatory bowel disease or colitis ≥ grade 2\n* Systemic chronic steroid therapy (>10mg/d prednisone or equivalent)\n* Active infection, including infection requiring systemic antibiotic therapy\n* Pregnant or breast-feeding (lactating) women\n* Participants with a history of allogeneic organ transplantation (e.g., stem cell or solid organ transplant)\n* Any medical condition that would in the investigator's judgement prevent the participant's participation in the clinical study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Adult patient aged ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Adult patient aged ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically (squamous or non-squamous) or cytologically documented locally advanced NSCLC not eligible for surgical resection and/or definitive chemoradiation, or metastatic NSCLC",
            "criterions": [
                {
                    "exact_snippets": "Histologically (squamous or non-squamous) or cytologically documented",
                    "criterion": "NSCLC documentation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "not eligible for surgical resection and/or definitive chemoradiation",
                    "criterion": "treatment eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "not eligible for surgical resection and/or definitive chemoradiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic treatment for locally advanced or metastatic NSCLC",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic treatment",
                    "criterion": "prior systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High tumor cell PD-L1 expression [Tumor Proportion Score (TPS) ≥50%] based on documented status as determined by an approved test",
            "criterions": [
                {
                    "exact_snippets": "High tumor cell PD-L1 expression ... Tumor Proportion Score (TPS) ≥50% ... as determined by an approved test",
                    "criterion": "tumor cell PD-L1 expression",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "test approval",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease as determined by RECIST v1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease as determined by RECIST v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "determination method",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g. EGFR mutation, ALK fusion oncogene, ROS1 aberrations)",
            "criterions": [
                {
                    "exact_snippets": "Tumors harboring driver mutations/genetic aberrations ... EGFR mutation",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumors harboring driver mutations/genetic aberrations ... ALK fusion oncogene",
                    "criterion": "ALK fusion oncogene",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumors harboring driver mutations/genetic aberrations ... ROS1 aberrations",
                    "criterion": "ROS1 aberrations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior immune checkpoint inhibitor therapy",
            "criterions": [
                {
                    "exact_snippets": "Prior immune checkpoint inhibitor therapy",
                    "criterion": "immune checkpoint inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Active brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection",
            "criterions": [
                {
                    "exact_snippets": "active and uncontrolled hepatitis B virus (HBV)",
                    "criterion": "hepatitis B virus (HBV) infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "active and uncontrolled ... hepatitis C virus (HCV) infection",
                    "criterion": "hepatitis C virus (HCV) infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled HIV infection. Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are allowed to enroll",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV who have controlled infection (undetectable viral load",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "undetectable viral load",
                    "criterion": "viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": "undetectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "CD4 count above 350",
                    "criterion": "CD4 count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 350,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stable antiviral regimen",
                    "criterion": "antiviral regimen",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active, known or suspected autoimmune disease or immune deficiency",
            "criterions": [
                {
                    "exact_snippets": "Active, known or suspected autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "known",
                                "suspected"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "immune deficiency",
                    "criterion": "immune deficiency",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "known",
                                "suspected"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hypersensitivity reactions to any ingredient of the investigational medicinal product (IMP) and other monoclonal antibody (mAbs) and/or their excipients",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity reactions to any ingredient of the investigational medicinal product (IMP)",
                    "criterion": "hypersensitivity reactions to IMP ingredients",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity reactions to ... other monoclonal antibody (mAbs)",
                    "criterion": "hypersensitivity reactions to monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity reactions to ... their excipients",
                    "criterion": "hypersensitivity reactions to excipients",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis ≥ grade 2",
            "criterions": [
                {
                    "exact_snippets": "History of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "idiopathic pulmonary fibrosis",
                    "criterion": "idiopathic pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "drug-induced pneumonitis",
                    "criterion": "drug-induced pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "idiopathic pneumonitis",
                    "criterion": "idiopathic pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active pneumonitis ≥ grade 2",
                    "criterion": "active pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of inflammatory bowel disease or colitis ≥ grade 2",
            "criterions": [
                {
                    "exact_snippets": "History of inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "colitis ≥ grade 2",
                    "criterion": "colitis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Systemic chronic steroid therapy (>10mg/d prednisone or equivalent)",
            "criterions": [
                {
                    "exact_snippets": "Systemic chronic steroid therapy (>10mg/d prednisone or equivalent)",
                    "criterion": "systemic chronic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/d prednisone or equivalent"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection, including infection requiring systemic antibiotic therapy",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "infection requiring systemic antibiotic therapy",
                    "criterion": "infection requiring systemic antibiotic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast-feeding (lactating) women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding (lactating)",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with a history of allogeneic organ transplantation (e.g., stem cell or solid organ transplant)",
            "criterions": [
                {
                    "exact_snippets": "history of allogeneic organ transplantation",
                    "criterion": "allogeneic organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any medical condition that would in the investigator's judgement prevent the participant's participation in the clinical study",
            "criterions": [
                {
                    "exact_snippets": "Any medical condition that would in the investigator's judgement prevent the participant's participation",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "prevents participation"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}