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
Phase 3
Completed
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT01887886
- Lead Sponsor
- Hoffmann-La Roche
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Erlotinib placebo - Onartuzumab + Erlotinib erlotinib - Placebo + Erlotinib erlotinib - Onartuzumab + Erlotinib onartuzumab -
- Primary Outcome Measures
Name Time Method Progression-free survival (investigator-assessed according to RECIST v1.1) approximately 3 years
- Secondary Outcome Measures
Name Time Method Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms approximately 3 years Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires approximately 3 years Overall survival approximately 3 years Pharmacokinetics: Area under the concentration-time curve (AUC) Day 1 Cycles 1, 2 and 4 Overall response rate approximately 3 years Safety: Incidence of adverse events approximately 3 years