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A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01496742
First received: December 19, 2011
Last updated: September 21, 2016
Last verified: September 2016
History of Changes

December 19, 2011
September 21, 2016
April 2012
November 2015   (final data collection date for primary outcome measure)
  • Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
  • Progression-free survival: Subgroup of patients with Met diagnostic positive tumors [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01496742 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
  • Overall response rate (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
  • Duration of response (time from first documented objective response to disease progression) [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
  • Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks) [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: serum concentration (Cmin/Cmax) [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and at study termination ] [ Designated as safety issue: No ]
  • Serum concentrations of bevacizumab/paclitaxel/pemetrexed/platinum in combination with MetMAb [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1 and 4 ] [ Designated as safety issue: No ]
  • Serum levels of anti-therapeutic antibodies (MetMAb ATAs) [ Time Frame: Pre-dose Day 1 of Cycles 1, 2 and 4 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer
A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Metmab Vs. Placebo in Combination With Either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum in Patients With Untreated Stage IIIb or IV Non-Squamous NSCLC
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive 4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Non-Squamous Non-Small Cell Lung Cancer
  • Drug: Placebo
    Matching RO5490258 (MetMAb) placebo iv, Day 1 of each 21-day cycle
  • Drug: RO5490258
    15 mg/kg iv, Day 1 of each 21-day cycle
    Other Name: MetMAb
  • Drug: bevacizumab [Avastin]
    15 mg/kg iv, Day 1 of each 21-day cycle
  • Drug: cisplatin/carboplatin
    standard dose iv, Day 1 of each 21-day cycle, 4 cycles
  • Drug: paclitaxel
    200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
  • Drug: pemetrexed
    500 mg/m2, Day 1 of each 21-day cycle
  • Experimental: Bevacizumab+MetMAb
    Interventions:
    • Drug: RO5490258
    • Drug: bevacizumab [Avastin]
    • Drug: cisplatin/carboplatin
    • Drug: paclitaxel
  • Active Comparator: Bevacizumab+Placebo
    Interventions:
    • Drug: Placebo
    • Drug: bevacizumab [Avastin]
    • Drug: cisplatin/carboplatin
    • Drug: paclitaxel
  • Experimental: Pemetrexed+MetMAb
    Interventions:
    • Drug: RO5490258
    • Drug: cisplatin/carboplatin
    • Drug: pemetrexed
  • Active Comparator: Pemetrexed+Placebo
    Interventions:
    • Drug: Placebo
    • Drug: cisplatin/carboplatin
    • Drug: pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
259
November 2015
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically or cytologically confirmed Stage IIIB or Stage IV non-squamous non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • For patients who received prior adjuvant chemotherapy or chemoradiotherapy: a treatment-free interval of at least 12 months since last chemotherapy or chemoradiotherapy cycle
  • Adequate tissue for central immunohistochemical (IHC) assay of Met receptor, and epidermal growth factor receptor (EGFR) testing if EGFR status is unknown
  • Radiographic evidence of disease

Exclusion Criteria:

  • Prior systemic treatment for Stage IIIB or IV non-squamous NSCLC
  • Evidence of mixed NSCLC with a predominance of the squamous cell type
  • Prior exposure to experimental treatment targeting either the hepatocyte growth factor (HGF) or Met pathway
  • 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, unless that treatment is unavailable or refused by the patient
  • Known central nervous system (CNS) disease, other than stable, treated brain metastases
  • History of another malignancy in the previous 3 years, except for history of in situ cancer that was treated surgically with curative intent, localized prostate cancer that has been treated surgically with curative intent, or basal or squamous cell skin cancer
  • Uncontrolled diabetes
  • Pregnant or lactating women
  • Impaired bone marrow, liver or renal function (as defined by protocol)
  • Significant history of cardiovascular disease
  • Positive for HIV infection
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   France,   Germany,   Israel,   Italy,   Latvia,   Malaysia,   Mexico,   Philippines,   Spain,   Taiwan,   United Kingdom
Brazil,   Portugal,   Russian Federation
 
NCT01496742
GO27821, 2011-003719-42
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP