{
    "info": {
        "nct_id": "NCT05789082",
        "official_title": "A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation",
        "inclusion_criteria": "* Confirmation of Biomarker eligibility\n* Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy\n* No prior systemic treatment for advanced unresectable or metastatic NSCLC\n* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Known concomitant second oncogenic driver with available targeted treatment\n* Squamous cell histology NSCLC\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Prior treatment with a KRAS G12C inhibitor\n* Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only)\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment\n* History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer\n* Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Confirmation of Biomarker eligibility",
            "criterions": [
                {
                    "exact_snippets": "Confirmation of Biomarker eligibility",
                    "criterion": "biomarker eligibility",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.",
            "criterions": [
                {
                    "exact_snippets": "Pre-treatment tumor tissue ... is required",
                    "criterion": "pre-treatment tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "associated pathology report is required",
                    "criterion": "associated pathology report",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides",
                    "criterion": "tumor specimen format",
                    "requirements": [
                        {
                            "requirement_type": "format",
                            "expected_value": [
                                "formalin-fixed, paraffin embedded (FFPE) blocks",
                                "15 unstained, freshly cut, serial slides"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor",
                    "criterion": "number of slides",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 15,
                                        "unit": "slides"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "minimum quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 10,
                                        "unit": "slides"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically documented",
                    "criterion": "documentation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced unresectable or metastatic NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not eligible for curative surgery and/or definitive chemoradiotherapy",
                    "criterion": "treatment eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "not eligible for curative surgery and/or definitive chemoradiotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic treatment for advanced unresectable or metastatic NSCLC",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic treatment",
                    "criterion": "prior systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced unresectable or metastatic NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (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": "* Known concomitant second oncogenic driver with available targeted treatment",
            "criterions": [
                {
                    "exact_snippets": "Known concomitant second oncogenic driver",
                    "criterion": "concomitant second oncogenic driver",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "available targeted treatment",
                    "criterion": "targeted treatment",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Squamous cell histology NSCLC",
            "criterions": [
                {
                    "exact_snippets": "Squamous cell histology NSCLC",
                    "criterion": "NSCLC histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "squamous cell"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "progression status",
                            "expected_value": "actively progressing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with a KRAS G12C inhibitor",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with a KRAS G12C inhibitor",
                    "criterion": "KRAS G12C inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment",
            "criterions": [
                {
                    "exact_snippets": "History of idiopathic pulmonary fibrosis",
                    "criterion": "idiopathic pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... organizing pneumonia (e.g., bronchiolitis obliterans)",
                    "criterion": "organizing pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... drug-induced pneumonitis",
                    "criterion": "drug-induced pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... idiopathic pneumonitis",
                    "criterion": "idiopathic pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of active pneumonitis",
                    "criterion": "active pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active tuberculosis",
                    "criterion": "active tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "significant cardiovascular disease within 3 months prior to initiation of study treatment",
                    "criterion": "significant cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 3 months prior to initiation of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer",
            "criterions": [
                {
                    "exact_snippets": "History of malignancy other than NSCLC within 5 years prior to initiation of study treatment",
                    "criterion": "history of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "NSCLC"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more >90%)",
                    "criterion": "risk of metastasis or death",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "negligible"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanoma skin carcinoma",
                    "criterion": "non-melanoma skin carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "localized prostate cancer",
                    "criterion": "localized prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ductal breast carcinoma in situ",
                    "criterion": "ductal breast carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage I uterine cancer",
                    "criterion": "Stage I uterine cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "I"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled tumor related pain",
                    "criterion": "tumor related pain",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "drainage requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pericardial effusion",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "drainage requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ascites requiring recurrent drainage procedures",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "drainage requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled or symptomatic hypercalcemia",
                    "criterion": "hypercalcemia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only)",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to any of the components of divarasib",
                    "criterion": "hypersensitivity to divarasib components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known hypersensitivity to pemetrexed",
                    "criterion": "hypersensitivity to pemetrexed",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known hypersensitivity to carboplatin",
                    "criterion": "hypersensitivity to carboplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known hypersensitivity to cisplatin",
                    "criterion": "hypersensitivity to cisplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}