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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

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ClinicalTrials.gov Identifier: NCT01496742
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE December 19, 2011
First Posted Date  ICMJE December 21, 2011
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2011)
  • Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 23 months ]
  • Progression-free survival: Subgroup of patients with Met diagnostic positive tumors [ Time Frame: up to approximately 23 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2011)
  • Overall survival [ Time Frame: up to approximately 23 months ]
  • Overall response rate (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 23 months ]
  • Duration of response (time from first documented objective response to disease progression) [ Time Frame: up to approximately 23 months ]
  • 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 ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 23 months ]
  • Pharmacokinetics: serum concentration (Cmin/Cmax) [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and at study termination ]
  • 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 ]
  • Serum levels of anti-therapeutic antibodies (MetMAb ATAs) [ Time Frame: Pre-dose Day 1 of Cycles 1, 2 and 4 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Non-Squamous Non-Small Cell Lung Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2016)
259
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2011)
260
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   France,   Germany,   Israel,   Italy,   Latvia,   Malaysia,   Mexico,   Philippines,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Brazil,   Portugal,   Russian Federation
 
Administrative Information
NCT Number  ICMJE NCT01496742
Other Study ID Numbers  ICMJE GO27821
2011-003719-42 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date September 2016

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