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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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01887886
Collaborator
(none)
10
Enrollment
35
Locations
2
Arms
14
Duration (Months)
0.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Onartuzumab + Erlotinib

Drug: erlotinib
150 mg orally daily

Drug: onartuzumab
15 mg/kg IV every 3 weeks
Active Comparator: Placebo + Erlotinib

Drug: erlotinib
150 mg orally daily

Drug: placebo
IV every 3 weeks

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (investigator-assessed according to RECIST v1.1) [approximately 3 years]

Secondary Outcome Measures

  1. Overall survival [approximately 3 years]

  2. Overall response rate [approximately 3 years]

  3. Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms [approximately 3 years]

  4. Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires [approximately 3 years]

  5. Safety: Incidence of adverse events [approximately 3 years]

  6. Pharmacokinetics: Area under the concentration-time curve (AUC) [Day 1 Cycles 1, 2 and 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bakersfield California United States 93309
2 Fullerton California United States 92835
3 Long Beach California United States 90813
4 Los Angeles California United States 90095-1772
5 Los Angeles California United States 90095
6 San Luis Obispo California United States 93454
7 Fort Myers Florida United States 33905
8 Orlando Florida United States 32803
9 Saint Petersburg Florida United States 33705
10 Chicago Illinois United States 60637
11 Marrero Louisiana United States 70072
12 Metairie Louisiana United States 70006
13 St. Louis Missouri United States 63110
14 Canton Ohio United States 44718
15 Nashville Tennessee United States 37203
16 Caen France 14076
17 Lyon France 69373
18 Nantes France 44805
19 Grosshansdorf Germany 22927
20 Oldenburg Germany 26121
21 Villingen-Schwenningen Germany 78052
22 Ehime Japan 791-0280
23 Okayama Japan 700-8558
24 Yamaguchi Japan 755-0241
25 Gwangju Korea, Republic of 501-757
26 Suwon-si, Korea, Republic of 442-723
27 Tanjung Bungah Malaysia 11200
28 Barcelona Spain 08025
29 Barcelona Spain 08035
30 Madrid Spain 28007
31 Madrid Spain 28050
32 Madrid Spain 28222
33 Taichung Taiwan 40447
34 Taipei Taiwan 00112
35 Taipei Taiwan 100

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01887886
Other Study ID Numbers:
  • GO28758
  • 2013-000868-29
First Posted:
Jun 27, 2013
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Erlotinib Hydrochloride

Study Results

No Results Posted as of Nov 2, 2016