A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

September 1, 2016 updated by: Genentech, Inc.

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
      • La Rioja, Argentina, F5300COE
      • Santa Rosa, Argentina, L6304BOC
  • France
      • Grenoble, France, 38043
      • Lyon, France, 69373
      • Paris, France, 75674
      • Rennes, France, 35033
  • Germany
      • Berlin, Germany, 12203
      • Göttingen, Germany, 37075
      • Halle (Saale), Germany, 06120
      • Immenhausen, Germany, 34376
      • München, Germany, 81925
      • Münster, Germany, 48149
  • Israel
      • Afula, Israel, 18101
      • Ashkelon, Israel, 78278
      • Tel Aviv, Israel, 6423906
      • Zerifin, Israel, 6093000
  • Italy
    • Campania
      • Avellino, Campania, Italy, 83100
      • Napoli, Campania, Italy, 80131
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
    • Lombardia
      • Cremona, Lombardia, Italy, 26100
      • Milano, Lombardia, Italy, 20133
  • Latvia
      • Daugavpils, Latvia, 5417
      • Liepaja, Latvia, LV 3401
      • Riga, Latvia, LV-1002
      • Riga, Latvia, LV 1079
  • Spain
      • Barcelona, Spain, 08036
      • Madrid, Spain, 28007
      • Madrid, Spain, 28050
      • Zaragoza, Spain, 50009
    • Navarra
      • Pamplona, Navarra, Spain, 31008
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
      • Birmingham, United Kingdom, B9 5SS
      • Bournemouth, United Kingdom, BH7 7DW
      • Leeds, United Kingdom, LS9 7TF
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
    • Arizona
      • Scottsdale, Arizona, United States, 85259
    • California
      • Bakersfield, California, United States, 93309
      • Fullerton, California, United States, 92835
      • Los Angeles, California, United States, 90024
      • Los Angeles, California, United States, 90095-1772
      • Northridge, California, United States, 91328
      • Sacramento, California, United States, 95817
      • San Luis Obispo, California, United States, 93454
      • Santa Barbara, California, United States, 93105
      • Stanford, California, United States, 94305
    • Colorado
      • Grand Junction, Colorado, United States, 81502-1628
    • Florida
      • Boynton Beach, Florida, United States, 33435
      • Orlando, Florida, United States, 32804
      • Weston, Florida, United States, 33331
    • Georgia
      • Marietta, Georgia, United States, 30060
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Harvey, Illinois, United States, 60426
    • Indiana
      • Fort Wayne, Indiana, United States, 46815
      • Fort Wayne, Indiana, United States, 46845
      • Indianapolis, Indiana, United States, 46260
      • Muncie, Indiana, United States, 47303
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02114
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nevada
      • Las Vegas, Nevada, United States, 89148
    • North Carolina
      • Hickory, North Carolina, United States, 28602
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Middletown, Ohio, United States, 45042
    • Oregon
      • Bend, Oregon, United States, 97701
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
    • Washington
      • Seattle, Washington, United States, 98195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • No prior chemotherapy for squamous NSCLC
  • Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
  • Radiographic evidence of disease

Exclusion Criteria:

  • Prior systemic treatment for Stage IIIB or IV squamous NSCLC
  • NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
  • Prior exposure to experimental treatment targeting either the HGF or Met pathway
  • Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
  • Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1
  • History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer
  • Pregnant or lactating women
  • Uncontrolled diabetes
  • Impaired bone marrow, liver or renal function as defined by protocol
  • Significant history of cardiovascular disease
  • Positive for HIV infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MetMAb+paclitaxel+platinum
Drug: cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
Drug: onartuzumab
15 mg/kg iv, Day 1 of each 21-day cycle
Other Names:
  • MetMAb
Drug: paclitaxel
200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
Active Comparator: Placebo+paclitaxel+platinum
Drug: cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
Drug: paclitaxel
200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
Drug: Placebo
Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (tumor assessments according to RECIST criteria)
Time Frame: up to approximately 32 months
up to approximately 32 months
Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC
Time Frame: up to approximately 32 months
up to approximately 32 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: up to approximately 32 months
up to approximately 32 months
Overall response rate (tumor assessments according to RECIST criteria)
Time Frame: up to approximately 32 months
up to approximately 32 months
Duration of response (time from first documented objective response to disease progression)
Time Frame: up to approximately 32 months
up to approximately 32 months
Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)
Time Frame: up to approximately 32 months
up to approximately 32 months
Safety: Incidence of adverse events
Time Frame: up to approximately 32 months
up to approximately 32 months
Pharmacokinetics: serum concentration (Cmin/Cmax)
Time Frame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years
Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years
Plasma concentrations of paclitaxel/platinum
Time Frame: Pre- and post-dose on Day 1 of Cycles 1 and 4
Pre- and post-dose on Day 1 of Cycles 1 and 4
Serum levels of anti-therapeutic antibodies (MetMAb ATAs)
Time Frame: Pre-dose Day 1 of Cycles 1, 2 and 4
Pre-dose Day 1 of Cycles 1, 2 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO27820

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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