A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

November 1, 2016 updated by: Genentech, Inc.

A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is 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.
494

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 3

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
      • La Plata, Argentina, B1900BAJ
      • Quilmes, Argentina, 1878
      • Santa Fe, Argentina, S3000FFU
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Waratah, New South Wales, Australia, 2298
    • Queensland
      • Chermside, Queensland, Australia, 4032
    • South Australia
      • Adelaide, South Australia, Australia, 5041
    • Victoria
      • Parkville, Victoria, Australia, 3050
  • Belgium
      • Bruxelles, Belgium, 1200
      • Gent, Belgium, 9000
      • Gilly (Charleroi), Belgium, 6000
      • Liège, Belgium, 4000
      • Namur, Belgium, 5000
  • Brazil
    • BA
      • Salvador/BA, BA, Brazil, 41820-021
    • RS
      • Lajeado, RS, Brazil, 95900-000
      • Novo Hamburgo, RS, Brazil, 93510-250
    • SP
      • Jau, SP, Brazil, 17210-080
      • Sao Paulo, SP, Brazil, 08270-070
      • Sorocaba, SP, Brazil, 18030-005
  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
    • Ontario
      • Sault Ste Marie, Ontario, Canada, P6A 2C4
      • Toronto, Ontario, Canada, M5G 2M9
      • Toronto, Ontario, Canada, M4N 3M5
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
      • Montreal, Quebec, Canada, J4B 5Z7
  • Chile
      • Santiago, Chile
      • Santiago, Chile, Providencia
      • Temuco, Chile, 4810469
  • Croatia
      • Cakovec, Croatia, 40000
      • Dubrovnik, Croatia, 20000
      • Pula, Croatia, 52100
      • Zagreb, Croatia, 10000
  • France
      • Besancon, France, 25030
      • Caen, France, 14076
      • Grenoble, France, 38 043
      • Limoges, France, 87042
      • Marseille, France, 13915
      • Montpellier, France, 34295
      • Paris, France, 75970
      • Poitiers, France, 86021
      • Saint Herblain, France, 44805
      • Suresnes, France, 92151
      • Vandoeuvre-les-nancy, France, 54511
  • Germany
      • Bad Berka, Germany, 99437
      • Berlin, Germany, 14165
      • Grosshansdorf, Germany, 22927
      • Hamburg, Germany, 21075
      • Heidelberg, Germany, 69126
      • Karlsruhe, Germany, 76137
      • Mainz, Germany, 55131
      • München, Germany, 80336
      • Oldenburg, Germany, 26121
      • Regensburg, Germany, 93053
      • Ulm, Germany, 89081
      • Villingen-Schwenningen, Germany, 78052
  • Hong Kong
      • Pokfulam, Hong Kong
      • Shatin, Hong Kong
  • Hungary
      • Edeleny, Hungary, 3780
      • Miskolc, Hungary, 3529
      • Szombathely, Hungary, 9700
  • Ireland
      • Cork, Ireland
      • Dublin, Ireland, 8
  • Israel
      • Beer Sheva, Israel, 8410101
      • Haifa, Israel, 4959381
      • Jerusalem, Israel, 91120-01
      • Jerusalem, Israel, 9372212
      • Kfar-Saba, Israel, 4428164
      • Petach Tikva, Israel, 49100
      • Ramat Gan, Israel, 5262100
      • Rehovot, Israel, 76100
  • Italy
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italy, 33081
    • Liguria
      • Genova, Liguria, Italy, 16132
    • Lombardia
      • Milan, Lombardia, Italy, 20141
      • Monza, Lombardia, Italy, 20900
      • Rozzano, Lombardia, Italy, 20089
    • Marche
      • Ancona, Marche, Italy, 60121
    • Piemonte
      • Orbassano, Piemonte, Italy, 10043
    • Toscana
      • Lido Di Camaiore, Toscana, Italy, 55043
    • Umbria
      • Perugia, Umbria, Italy, 06123
  • Japan
      • Aichi, Japan, 464-8681
      • Chiba, Japan, 277-8577
      • Ehime, Japan, 791-0280
      • Fukuoka, Japan, 812-8582
      • Fukuoka, Japan, 811-1395
      • Hyogo, Japan, 650-0047
      • Hyogo, Japan, 673-8553
      • Kanagawa, Japan, 236-0051
      • Kyoto, Japan, 606-8507
      • Miyagi, Japan, 980-8574
      • Miyagi, Japan, 981-1293
      • Okayama, Japan, 700-8558
      • Okayama, Japan, 710-8602
      • Osaka, Japan, 534-0021
      • Osaka, Japan, 537-8511
      • Osaka, Japan, 589-8511
      • Osaka, Japan, 591-8555
      • Saitama, Japan, 362-0806
      • Shizuoka, Japan, 411-8777
      • Tokyo, Japan, 113-8677
      • Tokyo, Japan, 135-8550
      • Tokyo, Japan, 104-0045
      • Tokyo, Japan, 160-0023
      • Tokyo, Japan, 173-8605
      • Yamaguchi, Japan, 755-0241
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 443-380
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 05505
      • Seoul, Korea, Republic of, 06591
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
      • Groningen, Netherlands, 9700 RB
      • Maastricht, Netherlands, 6229 HX
  • Peru
      • Lima, Peru, Lima 27
      • Lima, Peru, Lima 1
      • Lima, Peru, L27
  • Poland
      • Gdansk, Poland, 80-952
      • Krakow, Poland, 31-531
      • Lodz, Poland, 93-509
      • Olsztyn, Poland, 10-357
      • Poznan, Poland
  • Russian Federation
      • Ivanovo, Russian Federation, 153040
      • Krasnodar, Russian Federation, 350040
      • Omsk, Russian Federation, 644013
      • Saint-Petersburg, Russian Federation, 197101
      • St. Petersburg, Russian Federation, 197022
      • St. Petersburg, Russian Federation, 189646
      • Tomsk, Russian Federation, 634050
  • Serbia
      • Belgrade, Serbia, 11000
      • Belgrade, Serbia, 11080
      • Kragujevac, Serbia, 34000
  • South Africa
      • Bloemfontein, South Africa, 9301
      • Johannesburg, South Africa, 2193
      • Sandton, South Africa, 2196
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08041
      • Barcelona, Spain, 08916
      • Madrid, Spain, 28034
      • Madrid, Spain, 28007
      • Madrid, Spain, 28222
      • Madrid, Spain, 28050
      • Sevilla, Spain, 41013
      • Valencia, Spain, 41014
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
  • Taiwan
      • Changhua, Taiwan, 500
      • Kaohsiung, Taiwan, 813
      • Taipei, Taiwan, 100
  • Ukraine
      • Cherkassy, Ukraine, 18009
      • Chernivtsi, Ukraine, 58013
      • Dnipropetrovsk, Ukraine, 49102
      • Sumy, Ukraine, 40005
      • Zaporizhzhya, Ukraine, 69040
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
      • Grimsby, United Kingdom, DN33 2BA
      • Leicester, United Kingdom, LE1 5WW
      • London, United Kingdom, SE1 9RT
      • London, United Kingdom, SW10 9NH
      • Manchester, United Kingdom, M2O 4BX
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
    • California
      • Hayward, California, United States, 94545
      • Modesto, California, United States, 95355
      • Oakland, California, United States, 94611
      • Orange, California, United States, 92868
      • Roseville, California, United States, 95661
      • Sacramento, California, United States, 95817
      • Sacramento, California, United States, 95825
      • San Diego, California, United States, 92108
      • San Francisco, California, United States, 94115
      • San Jose, California, United States, 95119
      • Santa Clara, California, United States, 95051
      • South San Francisco, California, United States, 94080
      • Vallejo, California, United States, 94589
      • Walnut Creek, California, United States, 94596
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Clearwater, Florida, United States, 33761
      • Fort Myers, Florida, United States, 33901
      • Jacksonville, Florida, United States, 32256
      • Jacksonville, Florida, United States, 32207
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Urbana, Illinois, United States, 61801
    • Iowa
      • Bettendorf, Iowa, United States, 52722
      • Sioux City, Iowa, United States, 51101
    • Kentucky
      • Louisville, Kentucky, United States, 40207
    • Maryland
      • Annapolis, Maryland, United States, 21401
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21237
      • Baltimore, Maryland, United States, 21231
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02115
      • Springfield, Massachusetts, United States, 01107
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
    • Minnesota
      • Duluth, Minnesota, United States, 55805
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • Nevada
      • Reno, Nevada, United States, 89502
    • New Mexico
      • Farmington, New Mexico, United States, 87401
    • New York
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
    • Ohio
      • Canton, Ohio, United States, 44718
      • Cleveland, Ohio, United States, 44106
      • Columbus, Ohio, United States, 43210
      • Columbus, Ohio, United States, 43219
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15232
    • South Carolina
      • Charleston, South Carolina, United States, 29403
      • Columbia, South Carolina, United States, 29210
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Knoxville, Tennessee, United States, 37909
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Dallas, Texas, United States, 75390
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
    • Virginia
      • Bristol, Virginia, United States, 24201
      • Roanoke, Virginia, United States, 24014

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 participants, greater than or equal to (>/=) 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor
  • Met diagnostic-positive status tested by immunohistochemistry (IHC)
  • Results of endothelial growth factor receptor (EGFR)-activating mutation testing
  • Radiographic evidence of disease
  • Prior treatment with at least one platinum-based line of treatment (for stage IIIb/IV) and no more than one additional line of chemotherapy treatment; the last dose of chemotherapy must have been administered >/= 21 days prior to Day 1
  • availability of tissue sample for diagnostic testing is required

Exclusion Criteria:

  • More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known EGFR-related toxicity resulting in dose modifications (EGFR inhibitors including but not limited to gefitinib, erlotinib and cetuximab)
  • Brain metastases or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease for >/= 14 days
  • History of another malignancy in the previous 3 years, unless cured by surgery alone and continuously disease free for at least 3 years; participants with prior history of non-invasive cancers are eligible
  • Inadequate hematological, biochemical or organ function
  • Significant history of cardiac disease
  • Serious active infection at time of randomization or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment
  • Any inflammatory changes of the surface of the eye
  • Clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases
  • Pregnant or lactating women
  • Positive for human immunodefinciency (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: Quadruple

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: Onartuzumab+Erlotinib
Participants will receive onartuzumab 15 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally once daily (QD) from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.
Drug: Erlotinib
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
Other Names:
  • Tarceva
Drug: Onartuzumab (MetMab)
Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • RO5490258
Placebo Comparator: Placebo+Erlotinib
Participants will receive onartuzumab matching placebo on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally QD from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.
Drug: Erlotinib
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
Other Names:
  • Tarceva
Drug: Placebo
Participants will receive onartuzumab matching placebo on Day 1 of every 3-week 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
Overall Survival
Time Frame: Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)

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
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) Scores
Time Frame: Screening, Day 1 of Cycles 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 (cycle length = 21 days), study drug discontinuation visit (up to approximately 18 months)
Screening, Day 1 of Cycles 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 (cycle length = 21 days), study drug discontinuation visit (up to approximately 18 months)
Onartuzumab Serum Concentrations
Time Frame: 1 hour pre-onartuzumab (Pr-O) infusion on Day 1 of Cycles 1, 2, and 4, 1 hour post-onartuzumab (Po-O) infusion on Day 1 of Cycle 1 (cycle length = 21 days and duration of infusion = 60 minutes), End of treatment (up to approximately 18 months)
1 hour pre-onartuzumab (Pr-O) infusion on Day 1 of Cycles 1, 2, and 4, 1 hour post-onartuzumab (Po-O) infusion on Day 1 of Cycle 1 (cycle length = 21 days and duration of infusion = 60 minutes), End of treatment (up to approximately 18 months)
Percentage of Participants With Disease Progression or Death
Time Frame: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Progression Free Survival (PFS)
Time Frame: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Percentage of Participants with an Objective Response Assessed Using RECIST V 1.1
Time Frame: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)

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.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 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, 2016

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.
January 1, 2016

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).
October 18, 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.
October 19, 2011

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.
October 20, 2011

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.
November 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.
November 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.
November 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.
  • OAM4971g
  • GO27761 (Other Identifier: Hoffmann-La Roche)
  • 2011-002224-40 (EudraCT Number)

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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