{
    "info": {
        "nct_id": "NCT01703091",
        "official_title": "A Randomized, Double-Blind, Phase 2 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy",
        "inclusion_criteria": "* Non-Small Cell Lung Cancer disease\n* Clinical stage IV or recurrent disease\n* One prior first-line platinum-based chemotherapy regimen with or without maintenance therapy\n* For Non-Small Cell Lung Cancer (NSCLC) tumors other than squamous cell histology, the epidermal growth factor receptor (EGFR) mutation status is known prior to randomization\n* For participants with activating epidermal growth factor receptor (EGFR) mutation only, prior epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) monotherapy (only one regimen in the setting of single use) should be utilized\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version RECIST version 1.1\n* Adequate organ function\n* Estimated life expectancy of at least 3 months.\nHealthy volunteers allowed\nMust have minimum age of 20 Years",
        "exclusion_criteria": "* Have undergone major surgery within 28 days prior to randomization or have planned major surgery during study treatment\n* Receiving concurrent treatment with other anticancer therapy\n* Central nervous system disease other than stable and treated brain metastasis\n* Has major blood vessel invasion or encasement by cancer\n* Has intratumor cavitation\n* Has a history of uncontrolled thrombotic disorder\n* Is receiving therapeutic anticoagulation with drugs\n* Is receiving chronic therapy with nonsteroidal anti-inflammatory drugs\n* Has a history of hemoptysis within 2 months prior to randomization\n* Has clinically relevant congestive heart failure\n* Has experienced any arterial thromboembolic event\n* Has uncontrolled arterial hypertension\n* Has had a serious or nonhealing wound or, ulcer\n* Has significant existing conditions",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Non-Small Cell Lung Cancer disease",
            "criterions": [
                {
                    "exact_snippets": "Non-Small Cell Lung Cancer",
                    "criterion": "Non-Small Cell Lung Cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical stage IV or recurrent disease",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage IV",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent disease",
                    "criterion": "disease recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* One prior first-line platinum-based chemotherapy regimen with or without maintenance therapy",
            "criterions": [
                {
                    "exact_snippets": "One prior first-line platinum-based chemotherapy regimen",
                    "criterion": "prior chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "platinum-based"
                        },
                        {
                            "requirement_type": "line",
                            "expected_value": "first-line"
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without maintenance therapy",
                    "criterion": "maintenance therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "optional"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Non-Small Cell Lung Cancer (NSCLC) tumors other than squamous cell histology, the epidermal growth factor receptor (EGFR) mutation status is known prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "Non-Small Cell Lung Cancer (NSCLC) tumors other than squamous cell histology",
                    "criterion": "NSCLC tumor histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-squamous"
                        }
                    ]
                },
                {
                    "exact_snippets": "epidermal growth factor receptor (EGFR) mutation status is known prior to randomization",
                    "criterion": "EGFR mutation status",
                    "requirements": [
                        {
                            "requirement_type": "knowledge",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For participants with activating epidermal growth factor receptor (EGFR) mutation only, prior epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) monotherapy (only one regimen in the setting of single use) should be utilized",
            "criterions": [
                {
                    "exact_snippets": "activating epidermal growth factor receptor (EGFR) mutation",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "activating"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) monotherapy",
                    "criterion": "EGFR-TKI monotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "only one regimen in the setting of single use",
                    "criterion": "EGFR-TKI monotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version RECIST version 1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version RECIST version 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated life expectancy of at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy of at least 3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Have undergone major surgery within 28 days prior to randomization or have planned major surgery during study treatment",
            "criterions": [
                {
                    "exact_snippets": "Have undergone major surgery within 28 days prior to randomization",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "have planned major surgery during study treatment",
                    "criterion": "planned major surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receiving concurrent treatment with other anticancer therapy",
            "criterions": [
                {
                    "exact_snippets": "Receiving concurrent treatment with other anticancer therapy",
                    "criterion": "concurrent anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Central nervous system disease other than stable and treated brain metastasis",
            "criterions": [
                {
                    "exact_snippets": "Central nervous system disease other than stable and treated brain metastasis",
                    "criterion": "central nervous system disease",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "other than stable and treated brain metastasis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has major blood vessel invasion or encasement by cancer",
            "criterions": [
                {
                    "exact_snippets": "major blood vessel invasion",
                    "criterion": "major blood vessel invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "encasement by cancer",
                    "criterion": "encasement by cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has intratumor cavitation",
            "criterions": [
                {
                    "exact_snippets": "Has intratumor cavitation",
                    "criterion": "intratumor cavitation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a history of uncontrolled thrombotic disorder",
            "criterions": [
                {
                    "exact_snippets": "history of uncontrolled thrombotic disorder",
                    "criterion": "thrombotic disorder",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is receiving therapeutic anticoagulation with drugs",
            "criterions": [
                {
                    "exact_snippets": "receiving therapeutic anticoagulation with drugs",
                    "criterion": "therapeutic anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is receiving chronic therapy with nonsteroidal anti-inflammatory drugs",
            "criterions": [
                {
                    "exact_snippets": "receiving chronic therapy with nonsteroidal anti-inflammatory drugs",
                    "criterion": "chronic therapy with nonsteroidal anti-inflammatory drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a history of hemoptysis within 2 months prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "history of hemoptysis within 2 months prior to randomization",
                    "criterion": "history of hemoptysis",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 months prior to randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has clinically relevant congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "clinically relevant congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "clinical relevance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has experienced any arterial thromboembolic event",
            "criterions": [
                {
                    "exact_snippets": "Has experienced any arterial thromboembolic event",
                    "criterion": "arterial thromboembolic event",
                    "requirements": [
                        {
                            "requirement_type": "experience",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has uncontrolled arterial hypertension",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled arterial hypertension",
                    "criterion": "arterial hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has had a serious or nonhealing wound or, ulcer",
            "criterions": [
                {
                    "exact_snippets": "serious or nonhealing wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": [
                                "serious",
                                "nonhealing"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has significant existing conditions",
            "criterions": [
                {
                    "exact_snippets": "significant existing conditions",
                    "criterion": "existing conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}