{
    "info": {
        "nct_id": "NCT01091376",
        "official_title": "A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer",
        "inclusion_criteria": "* Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)\n* Tumor EGFR mutation\n* Presence of measurable disease by RECIST\n* stage IIIA or IIIB, non-resectable\n* ECOG performance status 0-2\n* No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy\n* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Carcinoid tumor, small cell carcinoma of lung\n* Patients with any distant metastasis\n* History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix\n* Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)\n* Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women\n* Women and men of childbearing potential who have no willing of employing adequate contraception\n* Tumor EGFR wild",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "histological proof",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "large cell carcinoma",
                    "criterion": "large cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor EGFR mutation",
            "criterions": [
                {
                    "exact_snippets": "Tumor EGFR mutation",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of measurable disease by RECIST",
            "criterions": [
                {
                    "exact_snippets": "Presence of measurable disease by RECIST",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurement method",
                            "expected_value": "RECIST"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* stage IIIA or IIIB, non-resectable",
            "criterions": [
                {
                    "exact_snippets": "stage IIIA or IIIB",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIA",
                                "IIIB"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "non-resectable",
                    "criterion": "resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... radiation therapy to chest",
                    "criterion": "prior radiation therapy to chest",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... immunotherapy",
                    "criterion": "prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... biologic therapy",
                    "criterion": "prior biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.",
            "criterions": [
                {
                    "exact_snippets": "Patients must sign an informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "indicating that they are aware of the investigational nature of the study",
                    "criterion": "awareness of investigational nature",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Carcinoid tumor, small cell carcinoma of lung",
            "criterions": [
                {
                    "exact_snippets": "Carcinoid tumor",
                    "criterion": "carcinoid tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "small cell carcinoma of lung",
                    "criterion": "small cell carcinoma of lung",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with any distant metastasis",
            "criterions": [
                {
                    "exact_snippets": "any distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix",
            "criterions": [
                {
                    "exact_snippets": "History of another malignancy",
                    "criterion": "history of another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except cured basal cell carcinoma of skin",
                    "criterion": "cured basal cell carcinoma of skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... cured carcinoma in-situ of uterine cervix",
                    "criterion": "cured carcinoma in-situ of uterine cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)",
            "criterions": [
                {
                    "exact_snippets": "active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction preceding 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias",
                    "criterion": "symptomatic heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "immunosuppressive treatment",
                    "criterion": "immunosuppressive treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant ... pregnant women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women who has not taken test of pregnancy (within 7 days before the first administration)",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days before the first administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women and men of childbearing potential who have no willing of employing adequate contraception",
            "criterions": [
                {
                    "exact_snippets": "Women and men of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no willing of employing adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor EGFR wild",
            "criterions": [
                {
                    "exact_snippets": "Tumor EGFR wild",
                    "criterion": "tumor EGFR",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "wild"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}