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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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