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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT01887886
• Other study ID #: GO28758
• Secondary ID: 2013-000868-29
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2013
• Last updated: November 1, 2016
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• erlotinib
150 mg orally daily
• onartuzumab
15 mg/kg IV every 3 weeks
• placebo
IV every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  France,  Germany,  Japan,  Korea, Republic of,  Malaysia,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (investigator-assessed according to RECIST v1.1)		approximately 3 years	No
Secondary	Overall survival		approximately 3 years	No
Secondary	Overall response rate		approximately 3 years	No
Secondary	Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms		approximately 3 years	No
Secondary	Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires		approximately 3 years	No
Secondary	Safety: Incidence of adverse events		approximately 3 years	No
Secondary	Pharmacokinetics: Area under the concentration-time curve (AUC)		Day 1 Cycles 1, 2 and 4	No