{
    "info": {
        "nct_id": "NCT00050960",
        "official_title": "Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer",
        "inclusion_criteria": "Healthy volunteers allowed",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Patients must have:\n\n* Pathologic (histologic or cytologic) confirmation of NSCLC\n* Stage IIIB with malignant pleural effusion or Stage IV disease\n* At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy\n* ECOG performance status 0 or 1\n* Adequate organ system function\n* Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).\n\nPatients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)\n\nPatients must not have had:\n\n* Brain metastasis\n* Prior chemotherapy for NSCLC\n* Prior platinum-based chemotherapy for any indication"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Pathologic (histologic or cytologic) confirmation of NSCLC",
            "criterions": [
                {
                    "exact_snippets": "Pathologic (histologic or cytologic) confirmation of NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologic (histologic or cytologic)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage IIIB with malignant pleural effusion or Stage IV disease",
            "criterions": [
                {
                    "exact_snippets": "Stage IIIB with malignant pleural effusion",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IIIB"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "malignant pleural effusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage IV disease",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable or evaluable NSCLC lesion",
                    "criterion": "NSCLC lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "NSCLC lesion ... that has not been previously irradiated",
                    "criterion": "NSCLC lesion irradiation status",
                    "requirements": [
                        {
                            "requirement_type": "irradiation status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "NSCLC lesion ... unless radiation therapy was more than three weeks prior to entry in the study",
                    "criterion": "NSCLC lesion irradiation timing",
                    "requirements": [
                        {
                            "requirement_type": "irradiation timing",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "NSCLC lesion ... the lesion has been shown to have progressed subsequent to the radiation therapy",
                    "criterion": "NSCLC lesion progression post-radiation",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ system function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ system function",
                    "criterion": "organ system function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).",
            "criterions": [
                {
                    "exact_snippets": "Fasting serum triglycerides that are within the age-adjusted normal range",
                    "criterion": "fasting serum triglycerides",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "age-adjusted normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "normalized with appropriate intervention such as antilipid therapy",
                    "criterion": "fasting serum triglycerides",
                    "requirements": [
                        {
                            "requirement_type": "normalization",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to complete at least four cycles of combination chemotherapy",
                    "criterion": "ability to complete chemotherapy cycles",
                    "requirements": [
                        {
                            "requirement_type": "minimum number of cycles",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "cycles"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Brain metastasis",
            "criterions": [
                {
                    "exact_snippets": "Brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy for NSCLC",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy for NSCLC",
                    "criterion": "chemotherapy for NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior platinum-based chemotherapy for any indication",
            "criterions": [
                {
                    "exact_snippets": "Prior platinum-based chemotherapy",
                    "criterion": "platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Patients must have:",
            "criterions": []
        },
        {
            "line": "Patients must not have had:",
            "criterions": []
        }
    ]
}