Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-03-29 @ 7:11 AM
Study NCT ID:
NCT01519804
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2011-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'C584058', 'term': 'onartuzumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'dispFirstSubmitDate': '2016-06-29', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-01', 'studyFirstSubmitDate': '2011-12-19', 'dispFirstSubmitQcDate': '2016-06-29', 'studyFirstSubmitQcDate': '2012-01-24', 'dispFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (tumor assessments according to RECIST criteria)', 'timeFrame': 'up to approximately 32 months'}, {'measure': 'Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC', 'timeFrame': 'up to approximately 32 months'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'up to approximately 32 months'}, {'measure': 'Overall response rate (tumor assessments according to RECIST criteria)', 'timeFrame': 'up to approximately 32 months'}, {'measure': 'Duration of response (time from first documented objective response to disease progression)', 'timeFrame': 'up to approximately 32 months'}, {'measure': 'Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)', 'timeFrame': 'up to approximately 32 months'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'up to approximately 32 months'}, {'measure': 'Pharmacokinetics: serum concentration (Cmin/Cmax)', 'timeFrame': 'Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years'}, {'measure': 'Plasma concentrations of paclitaxel/platinum', 'timeFrame': 'Pre- and post-dose on Day 1 of Cycles 1 and 4'}, {'measure': 'Serum levels of anti-therapeutic antibodies (MetMAb ATAs)', 'timeFrame': 'Pre-dose Day 1 of Cycles 1, 2 and 4'}]}, 'conditionsModule': {'conditions': ['Non-Squamous Non-Small Cell Lung Cancer']}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* No prior chemotherapy for squamous NSCLC\n* Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown\n* Radiographic evidence of disease\n\nExclusion Criteria:\n\n* Prior systemic treatment for Stage IIIB or IV squamous NSCLC\n* NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)\n* Prior exposure to experimental treatment targeting either the HGF or Met pathway\n* Patients 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\n* Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1\n* History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer\n* Pregnant or lactating women\n* Uncontrolled diabetes\n* Impaired bone marrow, liver or renal function as defined by protocol\n* Significant history of cardiovascular disease\n* Positive for HIV infection'}, 'identificationModule': {'nctId': 'NCT01519804', 'briefTitle': 'A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, '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)', 'orgStudyIdInfo': {'id': 'GO27820'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MetMAb+paclitaxel+platinum', 'interventionNames': ['Drug: cisplatin/carboplatin', 'Drug: onartuzumab', 'Drug: paclitaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo+paclitaxel+platinum', 'interventionNames': ['Drug: Placebo', 'Drug: cisplatin/carboplatin', 'Drug: paclitaxel']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle', 'armGroupLabels': ['Placebo+paclitaxel+platinum']}, {'name': 'cisplatin/carboplatin', 'type': 'DRUG', 'description': 'standard dose iv, Day 1 of each 21-day cycle, 4 cycles', 'armGroupLabels': ['MetMAb+paclitaxel+platinum', 'Placebo+paclitaxel+platinum']}, {'name': 'onartuzumab', 'type': 'DRUG', 'otherNames': ['MetMAb'], 'description': '15 mg/kg iv, Day 1 of each 21-day cycle', 'armGroupLabels': ['MetMAb+paclitaxel+platinum']}, {'name': 'paclitaxel', 'type': 'DRUG', 'description': '200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles', 'armGroupLabels': ['MetMAb+paclitaxel+platinum', 'Placebo+paclitaxel+platinum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92835', 'city': 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