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A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation

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ClinicalTrials.gov Identifier: NCT01887886
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Progression-free survival (investigator-assessed according to RECIST v1.1) [ Time Frame: approximately 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • Overall survival [ Time Frame: approximately 3 years ]
  • Overall response rate [ Time Frame: approximately 3 years ]
  • Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms [ Time Frame: approximately 3 years ]
  • Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires [ Time Frame: approximately 3 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Day 1 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 in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation
Official Title  ICMJE A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Erlotinib as First-Line Treatment for Patients With MET-Positive Unresectable Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation
Brief Summary This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. 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 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-Squamous Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: erlotinib
    150 mg orally daily
  • Drug: onartuzumab
    15 mg/kg IV every 3 weeks
  • Drug: placebo
    IV every 3 weeks
Study Arms  ICMJE
  • Experimental: Onartuzumab + Erlotinib
    Interventions:
    • Drug: erlotinib
    • Drug: onartuzumab
  • Active Comparator: Placebo + Erlotinib
    Interventions:
    • Drug: erlotinib
    • Drug: placebo
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 1, 2015)
10
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
300
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patient, >/= 18 years of age
  • Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
  • No prior treatment for unresectable Stage IIIB or IV NSCLC
  • Measurable radiographic evidence of disease according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Prior exposure to agents targeting either the Hepatocyte Growth Factor (HGF) or MET pathway
  • Exposure to an investigational or marketed agent that can act by EGFR inhibition
  • Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
  • Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for >/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for >/= 14 days prior to randomization are eligible.
  • History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease-free
  • Radiographically evident interstitial lung disease , concurrent infection, or a history of any of these conditions
  • Inadequate hematologic, biochemical, and organ function
  • Pregnant or lactating women
  • Life expectancy of < 12 weeks
  • Receipt of an investigational drug within 28 days prior to initiation of study treatment
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 France,   Germany,   Japan,   Korea, Republic of,   Malaysia,   Spain,   Taiwan,   United States
Removed Location Countries Hong Kong,   Italy,   Philippines,   Singapore,   Thailand,   Vietnam
 
Administrative Information
NCT Number  ICMJE NCT01887886
Other Study ID Numbers  ICMJE GO28758
2013-000868-29 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

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