{
    "info": {
        "nct_id": "NCT00294762",
        "official_title": "A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers",
        "inclusion_criteria": "* Age >= 18\n* Histologically or cytologically documented non-small cell lung cancer (NSCLC)\n* Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2\n* Radiologically measurable or evaluable disease No prior chemotherapy\n* 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening\n* Tumor tissue block or fine needle aspirate\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Any concurrent anticancer therapy or radiation\n* Other active malignancy\n* Uncontrolled brain metastases\n* GI abnormalities\n* Severe abnormalities of the cornea\n* Significant cardiac disease\n* Active infection",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age >= 18",
            "criterions": [
                {
                    "exact_snippets": "Age >= 18",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically documented non-small cell lung cancer (NSCLC)",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically documented non-small cell lung cancer (NSCLC)",
                    "criterion": "non-small cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiologically measurable or evaluable disease No prior chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Radiologically measurable or evaluable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation method",
                            "expected_value": [
                                "radiologically measurable",
                                "evaluable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening",
            "criterions": [
                {
                    "exact_snippets": "1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening",
                    "criterion": "epithelial growth factor receptor (EGFR) pathway markers",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "at screening"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor tissue block or fine needle aspirate",
            "criterions": [
                {
                    "exact_snippets": "Tumor tissue block or fine needle aspirate",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "block",
                                "fine needle aspirate"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Any concurrent anticancer therapy or radiation",
            "criterions": [
                {
                    "exact_snippets": "Any concurrent anticancer therapy",
                    "criterion": "concurrent anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Any concurrent ... radiation",
                    "criterion": "concurrent radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other active malignancy",
            "criterions": [
                {
                    "exact_snippets": "Other active malignancy",
                    "criterion": "active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* GI abnormalities",
            "criterions": [
                {
                    "exact_snippets": "GI abnormalities",
                    "criterion": "GI abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe abnormalities of the cornea",
            "criterions": [
                {
                    "exact_snippets": "Severe abnormalities of the cornea",
                    "criterion": "cornea abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "Significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}