{
    "info": {
        "nct_id": "NCT01244191",
        "official_title": "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of ARQ197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer (NSCLC)",
        "inclusion_criteria": "* Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous non-small-cell lung cancer.\n* Measurable disease and documented disease progression following last prior therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1.\n* Have received one or two prior lines of systemic anti-cancer therapy therapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy. Patients who received only adjuvant treatment will be eligible only if disease progression occurred <6 months after completion of adjuvant therapy. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Resolution of any toxic effects of prior therapy (including radiotherapy) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0, Grade ≤1 (with the exception of alopecia and ≤grade 2 neuropathy). Subject must have recovered from significant surgery-related complications.\n* Demonstrate adequate bone marrow, liver, and renal functions, defined as:\n* ALT, AST, and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN) in subjects with no liver metastasis and ≤5.0 x ULN in subjects with liver metastasis.\n* Total bilirubin ≤ 1.5 × ULN (≤ 4 × ULN total and ≤1.5 × ULN direct bilirubin is acceptable for subjects with Gilbert's syndrome).\n* ANC ≥1.5 × 10^9/L.\n* Platelet count ≥100 × 10^9/L.\n* Hemoglobin ≥9.0 g/dL (transfusion and/or growth factor support allowed).\n* Serum creatinine ≤1.5 × ULN or creatinine clearance ≥ 60 mL/min.\n* Archival and/or fresh biopsy tissue sample must be available for biomarker determination. The status of the following biomarkers will be collected in this study: EGFR and KRAS mutation status prior to randomization, and MET status post randomization\n* If of child-bearing/reproductive potential (female or male), must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received\n* If female and of childbearing potential, must have a negative result of a pregnancy test (serum or urine) within 72 hours prior to initiating study treatment.\n* Must have signed and dated an approved Informed Consent Form (Including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests. Subjects must be fully informed about their illness and the investigational nature of the study protocol (including forseeable risks and possible side effects)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior therapy with an EGFR inhibitor and/or ARQ 197 (or other known c-MET inhibitor).\n* Receipt of any systemic anti-tumor treatment for NSCLC within 3 weeks prior to randomization.\n* Receipt of palliative radiotherapy within 2 weeks or radiotherapy for curative intent of target lesions within 3 weeks prior to randomization. Lesions subjected to radiotherapy within 3 weeks prior to randomization may not be used as target lesions.\n* Major surgical procedure within 3 weeks prior to randomization.\n* History of cardiac disease:\n\nCongestive heart failure defined as Class II to IV per New York Heart Association classification; active coronary artery disease; previously diagnosed symptomatic bradycardia (subjects with asymptomatic bradycardia and heart rate above 50 bpm are allowed) or other cardiac arrhythmia defined as ≥Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension; myocardial infarction that occurred within 6 months prior to study entry (myocardial infarction that occurred > 6 months prior to study entry is permitted).\n\n* Clinically unstable central nervous system (CNS) metastasis (to be enrolled in the study, subjects must have confirmation of stable disease by MRI or computed tomography (CT) scan within 4 weeks of randomization and have CNS metastases well controlled by steroids, anti-epileptics or other symptom-relieving medications).\n* Need to breastfeed a child during or within 12 weeks of completing the study.\n* Significant gastrointestinal disorder that, in the opinion of the investigator, could interfere with absorption of ARQ 197 and/or erlotinib (eg, Crohn's disease, small or large bowel resection, malabsorption syndrome).\n* Inability or unwillingness to swallow the complete doses of ARQ 197 or erlotinib.\n* Any known contraindication to treatment with, including hypersensitivity to, ARQ 197 or erlotinib.\n* History of malignancy other than NSCLC within the 5 years prior to randomization, with the exceptions of adequately treated intraepithelial carcinoma of the cervix uteri; prostate carcinoma with a prostate-specific antigen value <0.2 ng/mL; or basal or squamous-cell carcinoma of the skin.\n* Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).\n* Any other significant co-morbid condition that, in opinion of the investigator, would impair study participation or cooperation.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous non-small-cell lung cancer.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically unresectable",
                    "criterion": "surgical resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic (stage IIIB/IV)",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic",
                                "stage IIIB",
                                "stage IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "non-squamous non-small-cell lung cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-squamous non-small-cell lung cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease and documented disease progression following last prior therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented disease progression following last prior therapy",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "following last prior therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received one or two prior lines of systemic anti-cancer therapy therapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy. Patients who received only adjuvant treatment will be eligible only if disease progression occurred <6 months after completion of adjuvant therapy. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen.",
            "criterions": [
                {
                    "exact_snippets": "Have received one or two prior lines of systemic anti-cancer therapy",
                    "criterion": "prior lines of systemic anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "one of which must be a platinum-doublet therapy",
                    "criterion": "platinum-doublet therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who received only adjuvant treatment will be eligible only if disease progression occurred <6 months after completion of adjuvant therapy",
                    "criterion": "disease progression after adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen",
                    "criterion": "prior maintenance therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "consideration as same line",
                            "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": "* Resolution of any toxic effects of prior therapy (including radiotherapy) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0, Grade ≤1 (with the exception of alopecia and ≤grade 2 neuropathy). Subject must have recovered from significant surgery-related complications.",
            "criterions": [
                {
                    "exact_snippets": "Resolution of any toxic effects of prior therapy (including radiotherapy) ... Grade ≤1",
                    "criterion": "toxic effects of prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "exception"
                        }
                    ]
                },
                {
                    "exact_snippets": "≤grade 2 neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject must have recovered from significant surgery-related complications",
                    "criterion": "surgery-related complications",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Demonstrate adequate bone marrow, liver, and renal functions, defined as:",
            "criterions": [
                {
                    "exact_snippets": "adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... liver",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal functions",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 1.5 × ULN (≤ 4 × ULN total and ≤1.5 × ULN direct bilirubin is acceptable for subjects with Gilbert's syndrome).",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 × ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "≤ 4 × ULN total ... is acceptable for subjects with Gilbert's syndrome",
                    "criterion": "total bilirubin for subjects with Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "≤1.5 × ULN direct bilirubin is acceptable for subjects with Gilbert's syndrome",
                    "criterion": "direct bilirubin for subjects with Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ANC ≥1.5 × 10^9/L.",
            "criterions": [
                {
                    "exact_snippets": "ANC ≥1.5 × 10^9/L",
                    "criterion": "ANC (Absolute Neutrophil Count)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥100 × 10^9/L.",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥100 × 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥9.0 g/dL (transfusion and/or growth factor support allowed).",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "transfusion and/or growth factor support allowed",
                    "criterion": "support methods",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": [
                                "transfusion",
                                "growth factor support"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤1.5 × ULN or creatinine clearance ≥ 60 mL/min.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤1.5 × ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance ≥ 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Archival and/or fresh biopsy tissue sample must be available for biomarker determination. The status of the following biomarkers will be collected in this study: EGFR and KRAS mutation status prior to randomization, and MET status post randomization",
            "criterions": [
                {
                    "exact_snippets": "Archival and/or fresh biopsy tissue sample must be available for biomarker determination.",
                    "criterion": "biopsy tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "EGFR and KRAS mutation status prior to randomization",
                    "criterion": "EGFR and KRAS mutation status",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "MET status post randomization",
                    "criterion": "MET status",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "post randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If of child-bearing/reproductive potential (female or male), must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received",
            "criterions": [
                {
                    "exact_snippets": "If of child-bearing/reproductive potential (female or male)",
                    "criterion": "child-bearing/reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If female and of childbearing potential, must have a negative result of a pregnancy test (serum or urine) within 72 hours prior to initiating study treatment.",
            "criterions": [
                {
                    "exact_snippets": "female and of childbearing potential",
                    "criterion": "gender and childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "childbearing potential",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative result of a pregnancy test (serum or urine) within 72 hours prior to initiating study treatment",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours prior to initiating study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have signed and dated an approved Informed Consent Form (Including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests. Subjects must be fully informed about their illness and the investigational nature of the study protocol (including forseeable risks and possible side effects)",
            "criterions": [
                {
                    "exact_snippets": "Must have signed and dated an approved Informed Consent Form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed and dated",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Including HIPAA authorization, if applicable",
                    "criterion": "HIPAA authorization",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "if applicable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects must be fully informed about their illness",
                    "criterion": "patient information",
                    "requirements": [
                        {
                            "requirement_type": "illness information",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the investigational nature of the study protocol (including forseeable risks and possible side effects)",
                    "criterion": "study protocol information",
                    "requirements": [
                        {
                            "requirement_type": "investigational nature",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "foreseeable risks",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "possible side effects",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Prior therapy with an EGFR inhibitor and/or ARQ 197 (or other known c-MET inhibitor).",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with an EGFR inhibitor",
                    "criterion": "prior therapy with EGFR inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... ARQ 197 (or other known c-MET inhibitor)",
                    "criterion": "prior therapy with c-MET inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of any systemic anti-tumor treatment for NSCLC within 3 weeks prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of any systemic anti-tumor treatment for NSCLC within 3 weeks prior to randomization.",
                    "criterion": "systemic anti-tumor treatment for NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of palliative radiotherapy within 2 weeks or radiotherapy for curative intent of target lesions within 3 weeks prior to randomization. Lesions subjected to radiotherapy within 3 weeks prior to randomization may not be used as target lesions.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of palliative radiotherapy within 2 weeks",
                    "criterion": "palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since receipt",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy for curative intent of target lesions within 3 weeks prior to randomization",
                    "criterion": "curative intent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since receipt",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Lesions subjected to radiotherapy within 3 weeks prior to randomization may not be used as target lesions",
                    "criterion": "lesions subjected to radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since radiotherapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "use as target lesions",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgical procedure within 3 weeks prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure within 3 weeks prior to randomization.",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of cardiac disease:",
            "criterions": [
                {
                    "exact_snippets": "History of cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Congestive heart failure defined as Class II to IV per New York Heart Association classification; active coronary artery disease; previously diagnosed symptomatic bradycardia (subjects with asymptomatic bradycardia and heart rate above 50 bpm are allowed) or other cardiac arrhythmia defined as ≥Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension; myocardial infarction that occurred within 6 months prior to study entry (myocardial infarction that occurred > 6 months prior to study entry is permitted).",
            "criterions": [
                {
                    "exact_snippets": "Congestive heart failure defined as Class II to IV per New York Heart Association classification",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "Class"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "Class"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "active coronary artery disease",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "previously diagnosed symptomatic bradycardia (subjects with asymptomatic bradycardia and heart rate above 50 bpm are allowed)",
                    "criterion": "bradycardia",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "symptomatic"
                        },
                        {
                            "requirement_type": "heart rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "bpm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other cardiac arrhythmia defined as ≥Grade 2 according to NCI CTCAE, version 4.0",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction that occurred within 6 months prior to study entry (myocardial infarction that occurred > 6 months prior to study entry is permitted)",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically unstable central nervous system (CNS) metastasis (to be enrolled in the study, subjects must have confirmation of stable disease by MRI or computed tomography (CT) scan within 4 weeks of randomization and have CNS metastases well controlled by steroids, anti-epileptics or other symptom-relieving medications).",
            "criterions": [
                {
                    "exact_snippets": "Clinically unstable central nervous system (CNS) metastasis",
                    "criterion": "CNS metastasis",
                    "requirements": [
                        {
                            "requirement_type": "clinical stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmation of stable disease by MRI or computed tomography (CT) scan within 4 weeks of randomization",
                    "criterion": "stable disease confirmation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "MRI",
                                "computed tomography (CT) scan"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks of randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "CNS metastases well controlled by steroids, anti-epileptics or other symptom-relieving medications",
                    "criterion": "CNS metastases control",
                    "requirements": [
                        {
                            "requirement_type": "control method",
                            "expected_value": [
                                "steroids",
                                "anti-epileptics",
                                "other symptom-relieving medications"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Need to breastfeed a child during or within 12 weeks of completing the study.",
            "criterions": [
                {
                    "exact_snippets": "Need to breastfeed a child during or within 12 weeks of completing the study.",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during or within 12 weeks of completing the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant gastrointestinal disorder that, in the opinion of the investigator, could interfere with absorption of ARQ 197 and/or erlotinib (eg, Crohn's disease, small or large bowel resection, malabsorption syndrome).",
            "criterions": [
                {
                    "exact_snippets": "Significant gastrointestinal disorder ... could interfere with absorption of ARQ 197 and/or erlotinib",
                    "criterion": "gastrointestinal disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "interference with drug absorption",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Crohn's disease",
                    "criterion": "Crohn's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "small or large bowel resection",
                    "criterion": "bowel resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability or unwillingness to swallow the complete doses of ARQ 197 or erlotinib.",
            "criterions": [
                {
                    "exact_snippets": "Inability ... to swallow the complete doses of ARQ 197 or erlotinib.",
                    "criterion": "ability to swallow medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwillingness to swallow the complete doses of ARQ 197 or erlotinib.",
                    "criterion": "willingness to swallow medication",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any known contraindication to treatment with, including hypersensitivity to, ARQ 197 or erlotinib.",
            "criterions": [
                {
                    "exact_snippets": "Any known contraindication to treatment with ... ARQ 197",
                    "criterion": "contraindication to ARQ 197",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Any known contraindication to treatment with ... erlotinib",
                    "criterion": "contraindication to erlotinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... ARQ 197",
                    "criterion": "hypersensitivity to ARQ 197",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... erlotinib",
                    "criterion": "hypersensitivity to erlotinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of malignancy other than NSCLC within the 5 years prior to randomization, with the exceptions of adequately treated intraepithelial carcinoma of the cervix uteri; prostate carcinoma with a prostate-specific antigen value <0.2 ng/mL; or basal or squamous-cell carcinoma of the skin.",
            "criterions": [
                {
                    "exact_snippets": "History of malignancy other than NSCLC within the 5 years prior to randomization",
                    "criterion": "history of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than NSCLC"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the 5 years prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated intraepithelial carcinoma of the cervix uteri",
                    "criterion": "intraepithelial carcinoma of the cervix uteri",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate carcinoma with a prostate-specific antigen value <0.2 ng/mL",
                    "criterion": "prostate carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "prostate-specific antigen value",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.2,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "basal or squamous-cell carcinoma of the skin",
                    "criterion": "basal or squamous-cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).",
            "criterions": [
                {
                    "exact_snippets": "Known infection with human immunodeficiency virus (HIV)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known infection with ... hepatitis B virus (HBV)",
                    "criterion": "HBV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known infection with ... hepatitis C virus (HCV)",
                    "criterion": "HCV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other significant co-morbid condition that, in opinion of the investigator, would impair study participation or cooperation.",
            "criterions": [
                {
                    "exact_snippets": "Any other significant co-morbid condition",
                    "criterion": "co-morbid condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "in opinion of the investigator, would impair study participation or cooperation",
                    "criterion": "investigator's opinion on impairment",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": "would impair study participation or cooperation"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* ALT, AST, and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN) in subjects with no liver metastasis and ≤5.0 x ULN in subjects with liver metastasis.",
            "criterions": [
                {
                    "exact_snippets": "ALT, AST, and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN) in subjects with no liver metastasis",
                    "criterion": "ALT, AST, and alkaline phosphatase levels in subjects with no liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT, AST, and alkaline phosphatase ≤5.0 x ULN in subjects with liver metastasis",
                    "criterion": "ALT, AST, and alkaline phosphatase levels in subjects with liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5.0,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}