{
    "info": {
        "nct_id": "NCT01999673",
        "official_title": "SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Previously Treated Stage IIIb/IV Non-Squamous Non Small-Cell Lung Cancer",
        "inclusion_criteria": "* Male or female at least 18 years of age\n* Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)\n* Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate hematologic, renal and hepatic function\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC\n* Known history of bleeding disorders, eg, von Willebrand disease or hemophilia\n* Cavitary tumors or tumors invading or abutting large blood vessels\n* Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening\n* Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening\n* Grade 2 or higher peripheral neuropathy",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "* Male or female at least 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "documented stage IIIb/IV non-squamous NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIb",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "non-squamous NSCLC",
                    "criterion": "NSCLC type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-squamous"
                        }
                    ]
                },
                {
                    "exact_snippets": "according to the American Joint Committee on Cancer Staging Manual (7th Edition)",
                    "criterion": "staging manual edition",
                    "requirements": [
                        {
                            "requirement_type": "edition",
                            "expected_value": "7th"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.",
            "criterions": [
                {
                    "exact_snippets": "Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy.",
                    "criterion": "radiographic disease recurrence or progression",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during or after front-line platinum-based doublet chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with known epidermal growth factor receptor (EGFR) activating mutations",
                    "criterion": "epidermal growth factor receptor (EGFR) activating mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with ... anaplastic lymphoma kinase (ALK) translocations",
                    "criterion": "anaplastic lymphoma kinase (ALK) translocations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "appropriate targeted treatment should have been used",
                    "criterion": "appropriate targeted treatment",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic, renal and hepatic function",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic ... function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC",
            "criterions": [
                {
                    "exact_snippets": "Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC",
                    "criterion": "NSCLC histology",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "Squamous",
                                "small cell",
                                "carcinoid",
                                "adenosquamous",
                                "large-cell neuroendocrine",
                                "mixed histology containing small-cell",
                                "mixed histology containing squamous-cell"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of bleeding disorders, eg, von Willebrand disease or hemophilia",
            "criterions": [
                {
                    "exact_snippets": "Known history of bleeding disorders",
                    "criterion": "bleeding disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "von Willebrand disease",
                    "criterion": "von Willebrand disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemophilia",
                    "criterion": "hemophilia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cavitary tumors or tumors invading or abutting large blood vessels",
            "criterions": [
                {
                    "exact_snippets": "Cavitary tumors",
                    "criterion": "cavitary tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors invading ... large blood vessels",
                    "criterion": "tumor invasion of large blood vessels",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors ... abutting large blood vessels",
                    "criterion": "tumor abutting large blood vessels",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant bleeding such as gross hematuria",
                    "criterion": "gross hematuria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the 6 months before screening"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant bleeding such as ... GI bleeding",
                    "criterion": "GI bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the 6 months before screening"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant bleeding such as ... hemoptysis",
                    "criterion": "hemoptysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the 6 months before screening"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening",
            "criterions": [
                {
                    "exact_snippets": "Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening",
                    "criterion": "thromboembolic events",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Grade 2 or higher peripheral neuropathy",
            "criterions": [
                {
                    "exact_snippets": "Grade 2 or higher peripheral neuropathy",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Key",
                    "criterion": "key",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}