{
    "info": {
        "nct_id": "NCT01850147",
        "official_title": "Study of Efficacy and Safety of Sequential Low-dose Sunitinib With Chemotherapy in Advanced Non-small Cell Lung Cancer After Failure of Conventional Regimen",
        "inclusion_criteria": "* Histologic or cytologic diagnosis of stage IIIB/IV NSCLC\n* ECOG PS: 0,1\n* Unidimensional or bi-dimensional measurable disease\n* Receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor\n* Evidence of disease progression\n* Life expectancy >12 weeks\n* Neutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 9g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL, Creatinine < 1 UNL\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pre-existing hemoptysis of a severity > grade 3 by NCI CTCAE criteria within 4 weeks prior to study entry\n* Uncontrolled hypertension\n* CHF, angina or arrhythmias\n* LVEF < 1 UNL\n* Existing a second malignancy within 5 years\n* Infected with HIV",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologic or cytologic diagnosis of stage IIIB/IV NSCLC",
            "criterions": [
                {
                    "exact_snippets": [
                        "Histologic or cytologic diagnosis"
                    ],
                    "criterion": "diagnosis method",
                    "requirement_type": "type",
                    "expected_value": [
                        "histologic",
                        "cytologic"
                    ]
                },
                {
                    "exact_snippets": [
                        "stage IIIB/IV NSCLC"
                    ],
                    "criterion": "NSCLC stage",
                    "requirement_type": "stage",
                    "expected_value": [
                        "IIIB",
                        "IV"
                    ]
                }
            ]
        },
        {
            "line": "* ECOG PS: 0,1",
            "criterions": [
                {
                    "exact_snippets": [
                        "ECOG PS"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "value",
                    "expected_value": [
                        "0",
                        "1"
                    ]
                }
            ]
        },
        {
            "line": "* Unidimensional or bi-dimensional measurable disease",
            "criterions": [
                {
                    "exact_snippets": [
                        "Unidimensional or bi-dimensional measurable disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "measurability",
                    "expected_value": [
                        "unidimensional",
                        "bi-dimensional"
                    ]
                }
            ]
        },
        {
            "line": "* Receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor",
            "criterions": [
                {
                    "exact_snippets": [
                        "Receive prior treatment including first-line platinum-based chemotherapy"
                    ],
                    "criterion": "first-line platinum-based chemotherapy",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Receive prior treatment including",
                        "standard second-line chemotherapy"
                    ],
                    "criterion": "standard second-line chemotherapy",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Receive prior treatment including",
                        "1 EGF/EGFR inhibitor"
                    ],
                    "criterion": "EGF/EGFR inhibitor",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Evidence of disease progression",
            "criterions": [
                {
                    "exact_snippets": [
                        "Evidence of disease progression"
                    ],
                    "criterion": "disease progression",
                    "requirement_type": "evidence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Life expectancy >12 weeks",
            "criterions": [
                {
                    "exact_snippets": [
                        "Life expectancy >12 weeks"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 12
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Neutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 9g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL, Creatinine < 1 UNL",
            "criterions": [
                {
                    "exact_snippets": [
                        "Neutrophils > 1.5 109/l"
                    ],
                    "criterion": "neutrophils",
                    "requirement_type": "count",
                    "expected_value": {
                        "operator": ">",
                        "value": 1.5
                    }
                },
                {
                    "exact_snippets": [
                        "Platelets > 100 109/l"
                    ],
                    "criterion": "platelets",
                    "requirement_type": "count",
                    "expected_value": {
                        "operator": ">",
                        "value": 100
                    }
                },
                {
                    "exact_snippets": [
                        "Hemoglobin > 9g/dl"
                    ],
                    "criterion": "hemoglobin",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": ">",
                        "value": 9
                    }
                },
                {
                    "exact_snippets": [
                        "Total bilirubin < 1.5 UNL"
                    ],
                    "criterion": "total bilirubin",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 1.5
                    }
                },
                {
                    "exact_snippets": [
                        "AST (SGOT) and ALT (SGPT) < 2.5 UNL"
                    ],
                    "criterion": "AST (SGOT)",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 2.5
                    }
                },
                {
                    "exact_snippets": [
                        "AST (SGOT) and ALT (SGPT) < 2.5 UNL"
                    ],
                    "criterion": "ALT (SGPT)",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 2.5
                    }
                },
                {
                    "exact_snippets": [
                        "Alkaline phosphatases < 5 UNL"
                    ],
                    "criterion": "alkaline phosphatases",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 5
                    }
                },
                {
                    "exact_snippets": [
                        "Creatinine < 1 UNL"
                    ],
                    "criterion": "creatinine",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 1
                    }
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pre-existing hemoptysis of a severity > grade 3 by NCI CTCAE criteria within 4 weeks prior to study entry",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pre-existing hemoptysis",
                        "severity > grade 3"
                    ],
                    "criterion": "hemoptysis",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 3
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "within 4 weeks prior to study entry"
                    ],
                    "criterion": "time since hemoptysis",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": [
                        "Uncontrolled hypertension"
                    ],
                    "criterion": "hypertension",
                    "requirement_type": "control status",
                    "expected_value": "uncontrolled"
                }
            ]
        },
        {
            "line": "* CHF, angina or arrhythmias",
            "criterions": [
                {
                    "exact_snippets": [
                        "CHF"
                    ],
                    "criterion": "CHF",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "angina"
                    ],
                    "criterion": "angina",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "arrhythmias"
                    ],
                    "criterion": "arrhythmias",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* LVEF < 1 UNL",
            "criterions": [
                {
                    "exact_snippets": [
                        "LVEF < 1 UNL"
                    ],
                    "criterion": "LVEF",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "operator": "<",
                        "value": 1
                    }
                }
            ]
        },
        {
            "line": "* Existing a second malignancy within 5 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "Existing a second malignancy within 5 years"
                    ],
                    "criterion": "second malignancy",
                    "requirement_type": "existence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within 5 years"
                    ],
                    "criterion": "time since second malignancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Infected with HIV",
            "criterions": [
                {
                    "exact_snippets": [
                        "Infected with HIV"
                    ],
                    "criterion": "HIV infection",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}