{
    "info": {
        "nct_id": "NCT00965731",
        "official_title": "Phase 1/2, Open Label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Erlotinib With Or Without Pf 02341066 In Patients With Advanced Non Small Cell Adenocarcinoma Of The Lung.",
        "inclusion_criteria": "* histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)\n* evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease\n* tumors must have measurable disease as per RECIST\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* known interstitial lung disease\n* prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)",
            "criterions": [
                {
                    "exact_snippets": "histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC)",
                    "criterion": "Non-Small Cell Lung Cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma subtype (including mixed adenosquamous histology)",
                    "criterion": "adenocarcinoma subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "adenocarcinoma",
                                "mixed adenosquamous histology"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease",
            "criterions": [
                {
                    "exact_snippets": "evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST)",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "evaluation method",
                            "expected_value": "Response Evaluation Criterion in Solid Tumors (RECIST)"
                        }
                    ]
                },
                {
                    "exact_snippets": "after at least one but no more than 2 chemotherapy regimens for advanced disease",
                    "criterion": "chemotherapy regimens for advanced disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "regimens"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "regimens"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* tumors must have measurable disease as per RECIST",
            "criterions": [
                {
                    "exact_snippets": "tumors must have measurable disease as per RECIST",
                    "criterion": "tumors",
                    "requirements": [
                        {
                            "requirement_type": "measurable disease",
                            "expected_value": "as per RECIST"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* known interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "known interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)",
            "criterions": [
                {
                    "exact_snippets": "prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase",
                    "criterion": "prior treatment with EGFR tyrosine kinase agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior treatment with an agent that is known or proposed to be active by action on ... c-Met/HGF",
                    "criterion": "prior treatment with c-Met/HGF agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}