Description:
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.
Title
- Brief Title: 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: 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
Clinical Trial IDs
- ORG STUDY ID:
GO28758
- SECONDARY ID:
2013-000868-29
- NCT ID:
NCT01887886
Conditions
- Non-Squamous Non-Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
erlotinib | | Onartuzumab + Erlotinib |
onartuzumab | | Onartuzumab + Erlotinib |
placebo | | Placebo + Erlotinib |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Onartuzumab + Erlotinib | Experimental | | |
Placebo + Erlotinib | Active Comparator | | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival (investigator-assessed according to RECIST v1.1) |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall survival |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Overall response rate |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Safety: Incidence of adverse events |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Pharmacokinetics: Area under the concentration-time curve (AUC) |
Time Frame: | Day 1 Cycles 1, 2 and 4 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Hoffmann-La Roche |
Last Updated
November 2, 2016