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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

Primary Purpose

Non-Squamous Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
erlotinib
onartuzumab
placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Onartuzumab + Erlotinib

Placebo + Erlotinib

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival (investigator-assessed according to RECIST v1.1)

Secondary Outcome Measures

Overall survival
Overall response rate
Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms
Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires
Safety: Incidence of adverse events
Pharmacokinetics: Area under the concentration-time curve (AUC)

Full Information

First Posted
June 25, 2013
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01887886
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Onartuzumab + Erlotinib
Arm Type
Experimental
Arm Title
Placebo + Erlotinib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
erlotinib
Intervention Description
150 mg orally daily
Intervention Type
Drug
Intervention Name(s)
onartuzumab
Intervention Description
15 mg/kg IV every 3 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
IV every 3 weeks
Primary Outcome Measure Information:
Title
Progression-free survival (investigator-assessed according to RECIST v1.1)
Time Frame
approximately 3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
approximately 3 years
Title
Overall response rate
Time Frame
approximately 3 years
Title
Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms
Time Frame
approximately 3 years
Title
Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires
Time Frame
approximately 3 years
Title
Safety: Incidence of adverse events
Time Frame
approximately 3 years
Title
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time Frame
Day 1 Cycles 1, 2 and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1772
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93454
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Caen
ZIP/Postal Code
14076
Country
France
City
Lyon
ZIP/Postal Code
69373
Country
France
City
Nantes
ZIP/Postal Code
44805
Country
France
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
City
Yamaguchi
ZIP/Postal Code
755-0241
Country
Japan
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
City
Suwon-si,
ZIP/Postal Code
442-723
Country
Korea, Republic of
City
Tanjung Bungah
ZIP/Postal Code
11200
Country
Malaysia
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28050
Country
Spain
City
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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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