{
    "info": {
        "nct_id": "NCT01639001",
        "official_title": "PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF CRIZOTINIB VERSUS PEMETREXED/CISPLATIN OR PEMETREXED/CARBOPLATIN IN PREVIOUSLY UNTREATED EAST ASIAN PATIENTS WITH NON-SQUAMOUS CARCINOMA OF THE LUNG HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS",
        "inclusion_criteria": "* Histologically or cytologically proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung.\n* Positive for translocation or inversion events involving the ALK gene locus.\n* No prior systemic treatment for locally advanced or metastatic disease. Patients with brain metastases only if treated and neurologically stable for at least 2 weeks and are not taking any medications contraindicated in Exclusion Criteria\n* Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Current treatment on another therapeutic clinical trial.\n* Prior therapy directly targeting ALK.\n* Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. Appropriate treatment with anticoagulants is permitted.\n* Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.\n* Pregnancy or breastfeeding.\n* Use of drugs or foods that are known potent CYP3A inducers/inhibitors Concurrent use of drugs that are CYP3A substrates with narrow therapeutic indices.\n* Known HIV infection\n* History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.\n* Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or end-stage renal disease on hemodialysis, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically proven diagnosis",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced not suitable for local treatment",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        },
                        {
                            "requirement_type": "treatment suitability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent",
                    "criterion": "cancer recurrence",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic",
                    "criterion": "cancer metastasis",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-squamous cell carcinoma of the lung",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-squamous cell carcinoma of the lung"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive for translocation or inversion events involving the ALK gene locus.",
            "criterions": [
                {
                    "exact_snippets": "Positive for translocation or inversion events involving the ALK gene locus.",
                    "criterion": "ALK gene locus",
                    "requirements": [
                        {
                            "requirement_type": "translocation or inversion events",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic treatment for locally advanced or metastatic disease. Patients with brain metastases only if treated and neurologically stable for at least 2 weeks and are not taking any medications contraindicated in Exclusion Criteria",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic treatment for locally advanced or metastatic disease",
                    "criterion": "prior systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases only if treated and neurologically stable for at least 2 weeks",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "neurological stability",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not taking any medications contraindicated in Exclusion Criteria",
                    "criterion": "medications contraindicated in Exclusion Criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of a personally signed and dated informed consent document",
                    "criterion": "informed consent document",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness and ability to comply with scheduled visits",
                    "criterion": "compliance with scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness and ability to comply with ... treatment plans",
                    "criterion": "compliance with treatment plans",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness and ability to comply with ... laboratory tests",
                    "criterion": "compliance with laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness and ability to comply with ... other study procedures",
                    "criterion": "compliance with other study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness and ability to comply with ... completion of patient reported outcome [PRO] measures",
                    "criterion": "completion of patient reported outcome [PRO] measures",
                    "requirements": [
                        {
                            "requirement_type": "willingness and 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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Current treatment on another therapeutic clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "Current treatment on another therapeutic clinical trial.",
                    "criterion": "current treatment on another therapeutic clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy directly targeting ALK.",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy directly targeting ALK",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "ALK"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. Appropriate treatment with anticoagulants is permitted.",
            "criterions": [
                {
                    "exact_snippets": "myocardial infarction ... within the 3 months prior to starting study treatment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "severe/unstable angina ... within the 3 months prior to starting study treatment",
                    "criterion": "severe/unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "coronary/peripheral artery bypass graft ... within the 3 months prior to starting study treatment",
                    "criterion": "coronary/peripheral artery bypass graft",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure ... within the 3 months prior to starting study treatment",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accident including transient ischemic attack ... within the 3 months prior to starting study treatment",
                    "criterion": "cerebrovascular accident including transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2",
                    "criterion": "cardiac dysrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NCI CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled atrial fibrillation of any grade",
                    "criterion": "atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc interval >470 msec",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of drugs or foods that are known potent CYP3A inducers/inhibitors Concurrent use of drugs that are CYP3A substrates with narrow therapeutic indices.",
            "criterions": [
                {
                    "exact_snippets": "Use of drugs or foods that are known potent CYP3A inducers/inhibitors",
                    "criterion": "use of CYP3A inducers/inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent use of drugs that are CYP3A substrates with narrow therapeutic indices",
                    "criterion": "use of CYP3A substrates with narrow therapeutic indices",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known HIV infection",
            "criterions": [
                {
                    "exact_snippets": "Known HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or end-stage renal disease on hemodialysis, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.",
            "criterions": [
                {
                    "exact_snippets": "severe acute or chronic medical conditions",
                    "criterion": "severe acute or chronic medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe gastrointestinal conditions such as diarrhea or ulcer",
                    "criterion": "severe gastrointestinal conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric conditions",
                    "criterion": "psychiatric conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "end-stage renal disease on hemodialysis",
                    "criterion": "end-stage renal disease on hemodialysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormalities",
                    "criterion": "laboratory abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.",
            "criterions": [
                {
                    "exact_snippets": "History of extensive disseminated/bilateral ... interstitial fibrosis or interstitial lung disease",
                    "criterion": "extensive disseminated/bilateral interstitial fibrosis or interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease",
                    "criterion": "Grade 3 or 4 interstitial fibrosis or interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypersensitivity pneumonitis",
                    "criterion": "hypersensitivity pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of interstitial pneumonia",
                    "criterion": "interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of obliterative bronchiolitis",
                    "criterion": "obliterative bronchiolitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of pulmonary fibrosis",
                    "criterion": "pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not history of prior radiation pneumonitis",
                    "criterion": "prior radiation pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}