{ "FullStudy":{ "Rank":217560, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519804", "OrgStudyIdInfo":{ "OrgStudyId":"GO27820" }, "Organization":{ "OrgFullName":"Genentech, Inc.", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer", "OfficialTitle":"A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)" }, "StatusModule":{ "StatusVerifiedDate":"September 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 19, 2011", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"June 29, 2016", "DispFirstSubmitQCDate":"June 29, 2016", "DispFirstPostDateStruct":{ "DispFirstPostDate":"July 1, 2016", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"September 1, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 2, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Genentech, Inc.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Non-Squamous Non-Small Cell Lung Cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"108", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"MetMAb+paclitaxel+platinum", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: cisplatin/carboplatin", "Drug: onartuzumab", "Drug: paclitaxel" ] } },{ "ArmGroupLabel":"Placebo+paclitaxel+platinum", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo", "Drug: cisplatin/carboplatin", "Drug: paclitaxel" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo+paclitaxel+platinum" ] } },{ "InterventionType":"Drug", "InterventionName":"cisplatin/carboplatin", "InterventionDescription":"standard dose iv, Day 1 of each 21-day cycle, 4 cycles", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "MetMAb+paclitaxel+platinum", "Placebo+paclitaxel+platinum" ] } },{ "InterventionType":"Drug", "InterventionName":"onartuzumab", "InterventionDescription":"15 mg/kg iv, Day 1 of each 21-day cycle", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "MetMAb+paclitaxel+platinum" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "MetMAb" ] } },{ "InterventionType":"Drug", "InterventionName":"paclitaxel", "InterventionDescription":"200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "MetMAb+paclitaxel+platinum", "Placebo+paclitaxel+platinum" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Progression-free survival (tumor assessments according to RECIST criteria)", "PrimaryOutcomeTimeFrame":"up to approximately 32 months" },{ "PrimaryOutcomeMeasure":"Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC", "PrimaryOutcomeTimeFrame":"up to approximately 32 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Overall survival", "SecondaryOutcomeTimeFrame":"up to approximately 32 months" },{ "SecondaryOutcomeMeasure":"Overall response rate (tumor assessments according to RECIST criteria)", "SecondaryOutcomeTimeFrame":"up to approximately 32 months" },{ "SecondaryOutcomeMeasure":"Duration of response (time from first documented objective response to disease progression)", "SecondaryOutcomeTimeFrame":"up to approximately 32 months" },{ "SecondaryOutcomeMeasure":"Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)", "SecondaryOutcomeTimeFrame":"up to approximately 32 months" },{ "SecondaryOutcomeMeasure":"Safety: Incidence of adverse events", "SecondaryOutcomeTimeFrame":"up to approximately 32 months" },{ "SecondaryOutcomeMeasure":"Pharmacokinetics: serum concentration (Cmin/Cmax)", "SecondaryOutcomeTimeFrame":"Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years" },{ "SecondaryOutcomeMeasure":"Plasma concentrations of paclitaxel/platinum", "SecondaryOutcomeTimeFrame":"Pre- and post-dose on Day 1 of Cycles 1 and 4" },{ "SecondaryOutcomeMeasure":"Serum levels of anti-therapeutic antibodies (MetMAb ATAs)", "SecondaryOutcomeTimeFrame":"Pre-dose Day 1 of Cycles 1, 2 and 4" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAdult patients, >/= 18 years of age\nHistologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)\nEastern Cooperative Oncology Group (ECOG) performance status 0 or 1\nNo prior chemotherapy for squamous NSCLC\nAdequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown\nRadiographic evidence of disease\n\nExclusion Criteria:\n\nPrior systemic treatment for Stage IIIB or IV squamous NSCLC\nNSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)\nPrior exposure to experimental treatment targeting either the HGF or Met pathway\nPatients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator\nUncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1\nHistory of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer\nPregnant or lactating women\nUncontrolled diabetes\nImpaired bone marrow, liver or renal function as defined by protocol\nSignificant history of cardiovascular disease\nPositive for HIV infection", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Clinical Trials", "OverallOfficialAffiliation":"Genentech, Inc.", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Huntsville", "LocationState":"Alabama", "LocationZip":"35805", 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