{
    "info": {
        "nct_id": "NCT01498562",
        "official_title": "Randomized Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Patients With Advanced Non-small Cell Lung Cancer: Dual-agent Molecular Targeting of EGFR (DATE)",
        "inclusion_criteria": "* Provision of written informed consent prior to any study specific procedures\n* Unresectable non-small cell lung cancer\n* ECOG performance status of 0 to 2\n* Male or female; ≥ 20 years of age\n* Subjects whose disease has progressed after platinum-based chemotherapy\n* Subjects with measurable lesion\nHealthy volunteers allowed\nMust have minimum age of 20 Years",
        "exclusion_criteria": "* Inadequate organ functions\n* Disease progression after 2 or more previous chemotherapy regimens\n* Prior therapy with EGFR-tyrosine kinase inhibitor or Anti-EGFR Monoclonal Ab\n* Any clinically significant gastrointestinal abnormalities\n* Past medical history of interstitial lung disease\n* Pregnant or lactating female",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Provision of written informed consent prior to any study specific procedures",
            "criterions": [
                {
                    "exact_snippets": "Provision of written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unresectable non-small cell lung cancer",
            "criterions": [
                {
                    "exact_snippets": "Unresectable non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status of 0 to 2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 to 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": "* Male or female; ≥ 20 years of age",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 20 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects whose disease has progressed after platinum-based chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "disease has progressed after platinum-based chemotherapy",
                    "criterion": "disease progression after platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with measurable lesion",
            "criterions": [
                {
                    "exact_snippets": "measurable lesion",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "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 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Inadequate organ functions",
            "criterions": [
                {
                    "exact_snippets": "Inadequate organ functions",
                    "criterion": "organ functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease progression after 2 or more previous chemotherapy regimens",
            "criterions": [
                {
                    "exact_snippets": "Disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "2 or more previous chemotherapy regimens",
                    "criterion": "previous chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy with EGFR-tyrosine kinase inhibitor or Anti-EGFR Monoclonal Ab",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with EGFR-tyrosine kinase inhibitor",
                    "criterion": "EGFR-tyrosine kinase inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... Anti-EGFR Monoclonal Ab",
                    "criterion": "Anti-EGFR Monoclonal Ab therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior therapy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any clinically significant gastrointestinal abnormalities",
            "criterions": [
                {
                    "exact_snippets": "clinically significant gastrointestinal abnormalities",
                    "criterion": "gastrointestinal abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Past medical history of interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "Past medical history of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating female",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating female",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}