{
    "info": {
        "nct_id": "NCT00544960",
        "official_title": "A Phase 2, Randomized, 2-Arm, Double-Blind Study of AT-101 in Combination With Docetaxel Versus Docetaxel Plus Placebo in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)",
        "inclusion_criteria": "* Histologically or cytologically confirmed Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).\n* Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.\n* All patients must have measurable disease.\n* No unstable or progressive brain metastases.\n* Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.\n* ECOG performance status 0-1\n* Adequate hematologic function\n* Adequate liver and renal function\n* Ability to swallow oral medication\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior chemotherapy regimen containing docetaxel.\n* Active secondary malignancy.\n* Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.\n* Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage IIIb with pleural/pericardial effusion",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IIIb"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "pleural/pericardial effusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage IV non-small cell lung cancer (NSCLC)",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "non-small cell lung cancer (NSCLC)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.",
            "criterions": [
                {
                    "exact_snippets": "Progression of disease after one prior systemic chemotherapeutic regimen",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after one prior systemic chemotherapeutic regimen"
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy",
                    "criterion": "adjuvant therapy relapse",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 6 months of the last cycle of therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients may have received erlotinib in any setting",
                    "criterion": "erlotinib treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients must have measurable disease.",
            "criterions": [
                {
                    "exact_snippets": "measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No unstable or progressive brain metastases.",
            "criterions": [
                {
                    "exact_snippets": "No unstable or progressive brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": [
                                "stable",
                                "non-progressive"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.",
            "criterions": [
                {
                    "exact_snippets": "Patients may have received prior radiation therapy",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "they must have recovered from all treatment-related toxicities",
                    "criterion": "treatment-related toxicities",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic function",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate liver and renal function",
            "criterions": [
                {
                    "exact_snippets": "Adequate liver ... function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to swallow oral medication",
            "criterions": [
                {
                    "exact_snippets": "Ability to swallow oral medication",
                    "criterion": "ability to swallow oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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": "* Prior chemotherapy regimen containing docetaxel.",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy regimen containing docetaxel",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "content",
                            "expected_value": "docetaxel"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active secondary malignancy.",
            "criterions": [
                {
                    "exact_snippets": "Active secondary malignancy",
                    "criterion": "secondary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.",
            "criterions": [
                {
                    "exact_snippets": "serious uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure (CHF)",
                    "criterion": "congestive heart failure (CHF)",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illness/social situations that would limit compliance with the study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).",
            "criterions": [
                {
                    "exact_snippets": "Failure to recover from toxicities related to prior therapy",
                    "criterion": "recovery from toxicities related to prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "failure"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}