{
    "info": {
        "nct_id": "NCT00789373",
        "official_title": "A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment With Pemetrexed + Cisplatin for Advanced Non-squamous Non-Small Cell Lung Cancer.",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria for the Induction Phase:\n\n* You must sign an informed consent document for clinical research.\n* You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer.\n* You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.\n* You are allowed to have had prior radiation therapy as long as it was not to more than 25% of the bone marrow and did not include the whole pelvis. Thoracic radiation must be completed more than 30 days before the study. You must be recovered from the toxic effects (except hair loss).\n* You must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated by computed tomography (CT) Scan.\n* Your test results assessing the function of your blood forming tissue, kidneys, and liver must be satisfactory.\n* You must be 18 years of age or older.\n* Women must be sterile, postmenopausal or on contraception and men must be on contraception or sterile (e.g. post-vasectomy).\n\nExclusion Criteria for the Induction Phase:\n\n* You cannot have squamous cell and/or mixed small cell, non-small cell lung cancer\n* You cannot have received other investigational drugs within the last 30 days of entering the trial.\n* You cannot have previously completed or withdrawn from this study or any other study investigating pemetrexed.\n* You cannot have other serious on-going illnesses including active infections.\n* You cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial.\n* You cannot have had another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years. Patients with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years ago.\n* You cannot have known central nervous system (CNS) metastases, other than treated, stable brain metastasis.\n* You cannot be receiving nor have received any prior systemic anticancer therapy for lung cancer (including chemotherapy given after surgery in early-stage treatment).\n* You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).\n* You cannot have received a recent (within 30 days) or are receiving a yellow fever vaccination.\n* You are unable to stop taking more than 1.3 grams of aspirin on a daily basis or other non-steroidal anti-inflammatory drugs (NSAIDs).\n* You are unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids.\n* You cannot be pregnant or breastfeeding.\n\nInclusion criteria at Randomization for the Maintenance Phase:\n\n* You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.\n* You must have documented radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the patient to be randomized to the maintenance phase."
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "* You must sign an informed consent document for clinical research.",
            "criterions": [
                {
                    "exact_snippets": "sign an informed consent document",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer.",
            "criterions": [
                {
                    "exact_snippets": "Stage IIIB or IV",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIB",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "nonsquamous Non-Small Cell Lung Cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "nonsquamous Non-Small Cell Lung Cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.",
            "criterions": [
                {
                    "exact_snippets": "be physically mobile",
                    "criterion": "physical mobility",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "take care of yourself",
                    "criterion": "self-care ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be up and about",
                    "criterion": "general activity level",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "perform light activities such as light housework or office work",
                    "criterion": "ability to perform light activities",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You are allowed to have had prior radiation therapy as long as it was not to more than 25% of the bone marrow and did not include the whole pelvis. Thoracic radiation must be completed more than 30 days before the study. You must be recovered from the toxic effects (except hair loss).",
            "criterions": [
                {
                    "exact_snippets": "prior radiation therapy",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not to more than 25% of the bone marrow",
                    "criterion": "radiation to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "did not include the whole pelvis",
                    "criterion": "radiation to pelvis",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Thoracic radiation must be completed more than 30 days before the study",
                    "criterion": "thoracic radiation completion",
                    "requirements": [
                        {
                            "requirement_type": "time before study",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered from the toxic effects (except hair loss)",
                    "criterion": "recovery from toxic effects",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated by computed tomography (CT) Scan.",
            "criterions": [
                {
                    "exact_snippets": "at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines",
                    "criterion": "measurable tumor lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "measurement_guideline",
                            "expected_value": "RECIST"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease that can be evaluated by computed tomography (CT) Scan",
                    "criterion": "disease evaluable by CT Scan",
                    "requirements": [
                        {
                            "requirement_type": "evaluation_method",
                            "expected_value": "CT Scan"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Your test results assessing the function of your blood forming tissue, kidneys, and liver must be satisfactory.",
            "criterions": [
                {
                    "exact_snippets": "function of your blood forming tissue",
                    "criterion": "blood forming tissue function",
                    "requirements": [
                        {
                            "requirement_type": "function",
                            "expected_value": "satisfactory"
                        }
                    ]
                },
                {
                    "exact_snippets": "function of your ... kidneys",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "function",
                            "expected_value": "satisfactory"
                        }
                    ]
                },
                {
                    "exact_snippets": "function of your ... liver",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "function",
                            "expected_value": "satisfactory"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You must be 18 years of age or older.",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women must be sterile, postmenopausal or on contraception and men must be on contraception or sterile (e.g. post-vasectomy).",
            "criterions": [
                {
                    "exact_snippets": "Women must be sterile",
                    "criterion": "female sterility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Women must be ... postmenopausal",
                    "criterion": "female postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Women must be ... on contraception",
                    "criterion": "female contraception",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men must be on contraception",
                    "criterion": "male contraception",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men must be ... sterile (e.g. post-vasectomy)",
                    "criterion": "male sterility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You cannot have squamous cell and/or mixed small cell, non-small cell lung cancer",
            "criterions": [
                {
                    "exact_snippets": "squamous cell",
                    "criterion": "squamous cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mixed small cell, non-small cell lung cancer",
                    "criterion": "mixed small cell, non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You cannot have received other investigational drugs within the last 30 days of entering the trial.",
            "criterions": [
                {
                    "exact_snippets": "You cannot have received other investigational drugs within the last 30 days",
                    "criterion": "receipt of investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since last receipt",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You cannot have previously completed or withdrawn from this study or any other study investigating pemetrexed.",
            "criterions": [
                {
                    "exact_snippets": "You cannot have previously completed or withdrawn from this study",
                    "criterion": "previous participation in this study",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any other study investigating pemetrexed",
                    "criterion": "previous participation in other studies investigating pemetrexed",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You cannot have other serious on-going illnesses including active infections.",
            "criterions": [
                {
                    "exact_snippets": "other serious on-going illnesses",
                    "criterion": "serious on-going illnesses",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active infections",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial.",
            "criterions": [
                {
                    "exact_snippets": "serious cardiac condition, such as a heart attack, angina, or heart disease",
                    "criterion": "serious cardiac condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months of entering the trial",
                    "criterion": "time since serious cardiac condition",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You cannot have had another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years. Patients with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years ago.",
            "criterions": [
                {
                    "exact_snippets": "You cannot have had another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years.",
                    "criterion": "history of cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "superficial basal cell",
                                "superficial squamous (skin) cell",
                                "carcinoma in situ of the cervix"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years ago.",
                    "criterion": "history of prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "Gleason score"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "localization",
                            "expected_value": "localized"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You cannot have known central nervous system (CNS) metastases, other than treated, stable brain metastasis.",
            "criterions": [
                {
                    "exact_snippets": "known central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "treated, stable brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You cannot be receiving nor have received any prior systemic anticancer therapy for lung cancer (including chemotherapy given after surgery in early-stage treatment).",
            "criterions": [
                {
                    "exact_snippets": "You cannot be receiving ... any prior systemic anticancer therapy for lung cancer",
                    "criterion": "systemic anticancer therapy for lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "You cannot ... have received any prior systemic anticancer therapy for lung cancer",
                    "criterion": "prior systemic anticancer therapy for lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You cannot have received a recent (within 30 days) or are receiving a yellow fever vaccination.",
            "criterions": [
                {
                    "exact_snippets": "received a recent (within 30 days) ... yellow fever vaccination",
                    "criterion": "yellow fever vaccination",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        },
                        {
                            "requirement_type": "current status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You are unable to stop taking more than 1.3 grams of aspirin on a daily basis or other non-steroidal anti-inflammatory drugs (NSAIDs).",
            "criterions": [
                {
                    "exact_snippets": "unable to stop taking more than 1.3 grams of aspirin on a daily basis",
                    "criterion": "aspirin intake",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.3,
                                "unit": "grams per day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to stop taking ... other non-steroidal anti-inflammatory drugs (NSAIDs)",
                    "criterion": "NSAID intake",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You are unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids.",
            "criterions": [
                {
                    "exact_snippets": "unable or unwilling to take folic acid",
                    "criterion": "folic acid intake",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable or unwilling to take ... injections of vitamin B12",
                    "criterion": "vitamin B12 injections",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable or unwilling to take ... corticosteroids",
                    "criterion": "corticosteroids intake",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You cannot be pregnant or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "cannot be pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be ... breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.",
            "criterions": [
                {
                    "exact_snippets": "be physically mobile",
                    "criterion": "physical mobility",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "take care of yourself",
                    "criterion": "self-care ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be up and about",
                    "criterion": "general activity level",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "perform light activities such as light housework or office work",
                    "criterion": "ability to perform light activities",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* You must have documented radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the patient to be randomized to the maintenance phase.",
            "criterions": [
                {
                    "exact_snippets": "documented radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines",
                    "criterion": "tumor response",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "documented radiographic evidence"
                        },
                        {
                            "requirement_type": "response type",
                            "expected_value": [
                                "complete response (CR)",
                                "partial response (PR)",
                                "stable disease (SD)"
                            ]
                        },
                        {
                            "requirement_type": "guidelines",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST)"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization",
                    "criterion": "tumor assessment timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "between Cycle 4 (Day 1) of induction therapy and the date of randomization"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria for the Induction Phase:",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria for the Induction Phase:",
            "criterions": []
        },
        {
            "line": "* You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).",
            "criterions": [
                {
                    "exact_snippets": "clinically significant third-space fluid collections (e.g. ascites or pleural effusions)",
                    "criterion": "third-space fluid collections",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be controlled by drainage or other procedures",
                    "criterion": "control of third-space fluid collections",
                    "requirements": [
                        {
                            "requirement_type": "controllability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Inclusion criteria at Randomization for the Maintenance Phase:",
            "criterions": []
        }
    ]
}