{
    "info": {
        "nct_id": "NCT06249282",
        "official_title": "A Phase I Clinical Trial of Carfilzomib in Combination With Sotorasib in Patients With KRASG12C Mutated Advanced Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* Documented informed consent of the participant and/or legally authorized representative\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed NSCLC that is metastatic or advanced. The tumor must exhibit evidence of KRASG12C mutation which is determined by either a Clinical Laboratory Improvement Act (CLIA) certified ctDNA assay or by a CLIA certified tumor tissue assay\n* Measurable disease by RECIST v1.1\n* Failed prior KRAS inhibitor\n* Fully recovered from the acute toxic effects (except alopecia) from prior anti-cancer therapy\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Absolute neutrophil count (ANC) ≥ 1,500/mm^3 (performed within 14 days prior to day 1 of protocol therapy)\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin (Hb) ≥ 9 g/dL (performed within 14 days prior to day 1 of protocol therapy)\n* Platelets ≥ 100,000/mm^3 (performed within 14 days prior to day 1 of protocol therapy)\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease) (performed within 14 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) ≤ 3 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease) (performed within 14 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) ≤ 5 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease) (performed within 14 days prior to day 1 of protocol therapy)\n* Creatinine clearance of ≤ 1.5 x ULN or glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 (performed within 14 days prior to day 1 of protocol therapy)\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 14 days prior to day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 120 days after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Chemotherapy or immunotherapy within 21 days prior to day 1 of protocol therapy\n* Radiation therapy within 14 days prior to day 1 of protocol therapy\n* KRAS inhibitor within 14 days prior to day 1 of protocol therapy\n* Investigational therapy within 28 days prior to day 1 of protocol therapy (or 5 half-lives, use whichever is shorter)\n* Inability to previously tolerate (240 mg, QD) sotorasib\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Evidence of chronic hepatitis B virus (HBV) infection and HBV viral load detectable\n* Evidence of untreated chronic hepatitis C virus (HCV) infection. Patients with HCV infection currently on treatment are eligible if they have an undetectable HCV viral load\n* Active infection requiring antibiotics (not to be completed by day 1 of protocol therapy)\n* Known history of immunodeficiency virus (HIV) with detectable viral load\n* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* New York Heart Association (NYHA) class III or IV heart failure, myocardial infarction in the preceding 6 months, conduction abnormalities uncontrolled by medications\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Documented informed consent of the participant and/or legally authorized representative",
            "criterions": [
                {
                    "exact_snippets": "Documented informed consent of the participant",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "legally authorized representative",
                    "criterion": "legally authorized representative",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age: ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age: ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) ≤ 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed NSCLC that is metastatic or advanced. The tumor must exhibit evidence of KRASG12C mutation which is determined by either a Clinical Laboratory Improvement Act (CLIA) certified ctDNA assay or by a CLIA certified tumor tissue assay",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or advanced",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "advanced"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor must exhibit evidence of KRASG12C mutation",
                    "criterion": "KRASG12C mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "determined by either a Clinical Laboratory Improvement Act (CLIA) certified ctDNA assay or by a CLIA certified tumor tissue assay",
                    "criterion": "KRASG12C mutation determination method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "CLIA certified ctDNA assay",
                                "CLIA certified tumor tissue assay"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease by RECIST v1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease by RECIST v1.1",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failed prior KRAS inhibitor",
            "criterions": [
                {
                    "exact_snippets": "Failed prior KRAS inhibitor",
                    "criterion": "KRAS inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "treatment outcome",
                            "expected_value": "failed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fully recovered from the acute toxic effects (except alopecia) from prior anti-cancer therapy",
            "criterions": [
                {
                    "exact_snippets": "Fully recovered from the acute toxic effects ... from prior anti-cancer therapy",
                    "criterion": "recovery from acute toxic effects",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fully recovered"
                        }
                    ]
                },
                {
                    "exact_snippets": "except alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better",
            "criterions": [
                {
                    "exact_snippets": "known history or current symptoms of cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "history or symptoms",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of treatment with cardiotoxic agents",
                    "criterion": "treatment with cardiotoxic agents",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical risk assessment of cardiac function using the New York Heart Association Functional Classification ... class 2B or better",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "NYHA class",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "B"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy",
            "criterions": [
                {
                    "exact_snippets": "new or progressive brain metastases (active brain metastases)",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "new",
                                "progressive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treating physician determines that immediate central nervous system (CNS) specific treatment is not required",
                    "criterion": "CNS specific treatment requirement",
                    "requirements": [
                        {
                            "requirement_type": "immediacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unlikely to be required during the first cycle of therapy",
                    "criterion": "CNS specific treatment requirement",
                    "requirements": [
                        {
                            "requirement_type": "likelihood during first cycle",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥ 1,500/mm^3 (performed within 14 days prior to day 1 of protocol therapy)",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1,500/mm^3",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement",
            "criterions": [
                {
                    "exact_snippets": "Growth factor is not permitted within 14 days of ANC assessment",
                    "criterion": "growth factor administration",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cytopenia is secondary to disease involvement",
                    "criterion": "cytopenia",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "secondary to disease involvement"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin (Hb) ≥ 9 g/dL (performed within 14 days prior to day 1 of protocol therapy)",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin (Hb) ≥ 9 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100,000/mm^3 (performed within 14 days prior to day 1 of protocol therapy)",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement",
            "criterions": [
                {
                    "exact_snippets": "Platelet transfusions are not permitted within 14 days of platelet assessment",
                    "criterion": "platelet transfusion",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless cytopenia is secondary to disease involvement",
                    "criterion": "cytopenia",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "secondary to disease involvement"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease) (performed within 14 days prior to day 1 of protocol therapy)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 x upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless has Gilbert's disease",
                    "criterion": "Gilbert's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST) ≤ 3 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease) (performed within 14 days prior to day 1 of protocol therapy)",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ≤ 3 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease)",
                    "criterion": "Aspartate aminotransferase (AST) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level in the setting of liver metastatic disease",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alanine aminotransferase (ALT) ≤ 5 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease) (performed within 14 days prior to day 1 of protocol therapy)",
            "criterions": [
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ≤ 5 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease)",
                    "criterion": "Alanine aminotransferase (ALT) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 14 days prior to day 1 of protocol therapy",
                    "criterion": "Timing of ALT test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days prior to day 1 of protocol therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance of ≤ 1.5 x ULN or glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 (performed within 14 days prior to day 1 of protocol therapy)",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance of ≤ 1.5 x ULN",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2",
                    "criterion": "glomerular filtration rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min/1.73 m^2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 14 days prior to day 1 of protocol therapy)",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential (WOCBP)",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative urine or serum pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 14 days prior to day 1 of protocol therapy",
                    "criterion": "pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days prior to day 1 of protocol therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required",
            "criterions": [
                {
                    "exact_snippets": "urine test is positive",
                    "criterion": "urine test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "urine test ... cannot be confirmed as negative",
                    "criterion": "urine test result",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "cannot be confirmed as negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 120 days after the last dose of protocol therapy.",
            "criterions": [
                {
                    "exact_snippets": "Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity",
                    "criterion": "birth control or abstinence",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "females and males of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for the course of the study through at least 120 days after the last dose of protocol therapy",
                    "criterion": "duration of birth control or abstinence",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "course of the study through at least 120 days after the last dose of protocol therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)",
            "criterions": [
                {
                    "exact_snippets": "Childbearing potential defined as not being surgically sterilized (men and women)",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Childbearing potential defined as ... have not been free from menses for > 1 year (women only)",
                    "criterion": "menses",
                    "requirements": [
                        {
                            "requirement_type": "absence duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Chemotherapy or immunotherapy within 21 days prior to day 1 of protocol therapy",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy ... within 21 days prior to day 1 of protocol therapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "immunotherapy within 21 days prior to day 1 of protocol therapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiation therapy within 14 days prior to day 1 of protocol therapy",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy within 14 days prior to day 1 of protocol therapy",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* KRAS inhibitor within 14 days prior to day 1 of protocol therapy",
            "criterions": [
                {
                    "exact_snippets": "KRAS inhibitor within 14 days prior to day 1 of protocol therapy",
                    "criterion": "KRAS inhibitor usage",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Investigational therapy within 28 days prior to day 1 of protocol therapy (or 5 half-lives, use whichever is shorter)",
            "criterions": [
                {
                    "exact_snippets": "Investigational therapy within 28 days prior to day 1 of protocol therapy (or 5 half-lives, use whichever is shorter)",
                    "criterion": "investigational therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to previously tolerate (240 mg, QD) sotorasib",
            "criterions": [
                {
                    "exact_snippets": "Inability to previously tolerate (240 mg, QD) sotorasib",
                    "criterion": "sotorasib tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent",
                    "criterion": "allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "attribution",
                            "expected_value": "compounds of similar chemical or biologic composition to study agent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant uncontrolled illness",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant uncontrolled illness",
                    "criterion": "uncontrolled illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of chronic hepatitis B virus (HBV) infection and HBV viral load detectable",
            "criterions": [
                {
                    "exact_snippets": "Evidence of chronic hepatitis B virus (HBV) infection",
                    "criterion": "chronic hepatitis B virus (HBV) infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HBV viral load detectable",
                    "criterion": "HBV viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of untreated chronic hepatitis C virus (HCV) infection. Patients with HCV infection currently on treatment are eligible if they have an undetectable HCV viral load",
            "criterions": [
                {
                    "exact_snippets": "Evidence of untreated chronic hepatitis C virus (HCV) infection.",
                    "criterion": "chronic hepatitis C virus (HCV) infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with HCV infection currently on treatment ... undetectable HCV viral load",
                    "criterion": "HCV viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": "undetectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection requiring antibiotics (not to be completed by day 1 of protocol therapy)",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring antibiotics",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "antibiotics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of immunodeficiency virus (HIV) with detectable viral load",
            "criterions": [
                {
                    "exact_snippets": "Known history of immunodeficiency virus (HIV)",
                    "criterion": "immunodeficiency virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "detectable viral load",
                    "criterion": "viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen",
            "criterions": [
                {
                    "exact_snippets": "Prior or concurrent malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "temporal",
                            "expected_value": [
                                "prior",
                                "concurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen",
                    "criterion": "interference with investigational regimen",
                    "requirements": [
                        {
                            "requirement_type": "potential to interfere",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* New York Heart Association (NYHA) class III or IV heart failure, myocardial infarction in the preceding 6 months, conduction abnormalities uncontrolled by medications",
            "criterions": [
                {
                    "exact_snippets": "New York Heart Association (NYHA) class III or IV heart failure",
                    "criterion": "NYHA heart failure class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction in the preceding 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "conduction abnormalities uncontrolled by medications",
                    "criterion": "conduction abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "control by medications",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females only: Pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Females only",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "breastfeeding"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures",
            "criterions": [
                {
                    "exact_snippets": "Any other condition ... contraindicate the patient's participation ... due to safety concerns",
                    "criterion": "condition contraindicating participation",
                    "requirements": [
                        {
                            "requirement_type": "safety concern",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)",
            "criterions": [
                {
                    "exact_snippets": "may not be able to comply with all study procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "compliance issues related to feasibility/logistics",
                    "criterion": "feasibility/logistics",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}