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