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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

494

Phase

  • 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

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
Intervention / Treatment
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

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

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

Genentech, Inc.

Collaborators

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

January 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

October 18, 2011

First Submitted That Met QC Criteria

October 19, 2011

First Posted (Estimate)

October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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