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)
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
3 other identifiers
interventional
494
27 countries
213
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2012
Typical duration for phase_3
213 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedNovember 2, 2016
November 1, 2016
4 years
October 18, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Secondary Outcomes (5)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) Scores
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
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
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)
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
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)
Study Arms (2)
Onartuzumab+Erlotinib
EXPERIMENTALParticipants 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.
Placebo+Erlotinib
PLACEBO COMPARATORParticipants 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.
Interventions
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.
Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
- Hoffmann-La Rochecollaborator
Study Sites (213)
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Chandler, Arizona, 85224, United States
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Hayward, California, 94545, United States
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Modesto, California, 95355, United States
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Oakland, California, 94611, United States
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Orange, California, 92868, United States
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Roseville, California, 95661, United States
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Sacramento, California, 95817, United States
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Sacramento, California, 95825, United States
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San Diego, California, 92108, United States
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San Francisco, California, 94115, United States
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San Jose, California, 95119, United States
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Santa Clara, California, 95051, United States
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South San Francisco, California, 94080, United States
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Vallejo, California, 94589, United States
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Walnut Creek, California, 94596, United States
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Boca Raton, Florida, 33486, United States
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Clearwater, Florida, 33761, United States
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Fort Myers, Florida, 33901, United States
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Jacksonville, Florida, 32207, United States
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Jacksonville, Florida, 32256, United States
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Chicago, Illinois, 60637, United States
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Urbana, Illinois, 61801, United States
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Bettendorf, Iowa, 52722, United States
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Sioux City, Iowa, 51101, United States
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Louisville, Kentucky, 40207, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21231, United States
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Baltimore, Maryland, 21237, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02115, United States
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Springfield, Massachusetts, 01107, United States
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Ann Arbor, Michigan, 48106, United States
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Duluth, Minnesota, 55805, United States
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St Louis, Missouri, 63110, United States
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Omaha, Nebraska, 68114, United States
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Reno, Nevada, 89502, United States
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Farmington, New Mexico, 87401, United States
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Syracuse, New York, 13210, United States
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Chapel Hill, North Carolina, 27514, United States
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Canton, Ohio, 44718, United States
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Cleveland, Ohio, 44106, United States
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Columbus, Ohio, 43210, United States
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Columbus, Ohio, 43219, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Charleston, South Carolina, 29403, United States
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Columbia, South Carolina, 29210, United States
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Chattanooga, Tennessee, 37404, United States
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Knoxville, Tennessee, 37909, United States
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Nashville, Tennessee, 37203, United States
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Dallas, Texas, 75390, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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Bristol, Virginia, 24201, United States
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Roanoke, Virginia, 24014, United States
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La Plata, B1900BAJ, Argentina
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Quilmes, 1878, Argentina
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Santa Fe, S3000FFU, Argentina
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Camperdown, New South Wales, 2050, Australia
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Waratah, New South Wales, 2298, Australia
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Chermside, Queensland, 4032, Australia
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Adelaide, South Australia, 5041, Australia
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Parkville, Victoria, 3050, Australia
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Gilly (Charleroi), 6000, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Salvador/BA, Estado de Bahia, 41820-021, Brazil
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Lajeado, Rio Grande do Sul, 95900-000, Brazil
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Novo Hamburgo, Rio Grande do Sul, 93510-250, Brazil
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Jaú, São Paulo, 17210-080, Brazil
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São Paulo, São Paulo, 08270-070, Brazil
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Sorocaba, São Paulo, 18030-005, Brazil
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Saint John, New Brunswick, E2L 4L2, Canada
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Sault Ste. Marie, Ontario, P6A 2C4, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Montreal, Quebec, J4B 5Z7, Canada
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Santiago, 0, Chile
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Santiago, Providencia, Chile
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Temuco, 4810469, Chile
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Čakovec, 40000, Croatia
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Dubrovnik, 20000, Croatia
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Pula, 52100, Croatia
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Zagreb, 10000, Croatia
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Besançon, 25030, France
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Caen, 14076, France
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Grenoble, 38 043, France
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Limoges, 87042, France
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Marseille, 13915, France
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Montpellier, 34295, France
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Paris, 75970, France
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Poitiers, 86021, France
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Saint-Herblain, 44805, France
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Suresnes, 92151, France
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Vandœuvre-lès-Nancy, 54511, France
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Bad Berka, 99437, Germany
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Berlin, 14165, Germany
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Großhansdorf, 22927, Germany
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Hamburg, 21075, Germany
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Heidelberg, 69126, Germany
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Karlsruhe, 76137, Germany
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Mainz, 55131, Germany
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München, 80336, Germany
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Oldenburg, 26121, Germany
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Regensburg, 93053, Germany
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Ulm, 89081, Germany
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Villingen-Schwenningen, 78052, Germany
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Pokfulam, Hong Kong
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Shatin, Hong Kong
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Edelény, 3780, Hungary
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Miskolc, 3529, Hungary
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Szombathely, 9700, Hungary
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Cork, Ireland
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Dublin, 8, Ireland
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Beersheba, 8410101, Israel
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Haifa, 4959381, Israel
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Jerusalem, 91120-01, Israel
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Jerusalem, 9372212, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 5262100, Israel
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Rehovot, 76100, Israel
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Aviano, Friuli Venezia Giulia, 33081, Italy
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Genoa, Liguria, 16132, Italy
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Milan, Lombardy, 20141, Italy
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Monza, Lombardy, 20900, Italy
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Rozzano, Lombardy, 20089, Italy
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Orbassano, Piedmont, 10043, Italy
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Ancona, The Marches, 60121, Italy
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Lido di Camaiore, Tuscany, 55043, Italy
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Perugia, Umbria, 06123, Italy
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Aichi, 464-8681, Japan
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Chiba, 277-8577, Japan
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Ehime, 791-0280, Japan
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Fukuoka, 811-1395, Japan
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Fukuoka, 812-8582, Japan
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Hyōgo, 650-0047, Japan
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Hyōgo, 673-8553, Japan
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Kanagawa, 236-0051, Japan
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Kyoto, 606-8507, Japan
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Miyagi, 980-8574, Japan
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Miyagi, 981-1293, Japan
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Okayama, 700-8558, Japan
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Okayama, 710-8602, Japan
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Osaka, 534-0021, Japan
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Osaka, 537-8511, Japan
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Osaka, 589-8511, Japan
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Osaka, 591-8555, Japan
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Saitama, 362-0806, Japan
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Shizuoka, 411-8777, Japan
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Tokyo, 104-0045, Japan
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Tokyo, 113-8677, Japan
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Tokyo, 135-8550, Japan
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Tokyo, 160-0023, Japan
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Tokyo, 173-8605, Japan
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Yamaguchi, 755-0241, Japan
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Amsterdam, 1081 HV, Netherlands
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Groningen, 9700 RB, Netherlands
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Maastricht, 6229 HX, Netherlands
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Lima, L27, Peru
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Lima, Lima 1, Peru
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Lima, Lima 27, Peru
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Gdansk, 80-952, Poland
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Krakow, 31-531, Poland
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Lodz, 93-509, Poland
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Olsztyn, 10-357, Poland
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Poznan, Poland
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Ivanovo, 153040, Russia
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Krasnodar, 350040, Russia
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Omsk, 644013, Russia
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Saint Petersburg, 189646, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197101, Russia
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Tomsk, 634050, Russia
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Belgrade, 11000, Serbia
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Belgrade, 11080, Serbia
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Kragujevac, 34000, Serbia
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Bloemfontein, 9301, South Africa
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Johannesburg, 2193, South Africa
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Sandton, 2196, South Africa
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Gyeonggi-do, 443-380, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Seoul, 120-752, South Korea
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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Barcelona, Barcelona, 08041, Spain
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Barcelona, Barcelona, 08916, Spain
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Sabadell, Barcelona, 08208, Spain
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Madrid, Madrid, 28007, Spain
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Madrid, Madrid, 28034, Spain
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Madrid, Madrid, 28050, Spain
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Madrid, Madrid, 28222, Spain
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Seville, Sevilla, 41013, Spain
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Valencia, Valencia, 41014, Spain
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Changhua, 500, Taiwan
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Kaohsiung City, 813, Taiwan
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Taipei, 100, Taiwan
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Cherkassy, 18009, Ukraine
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Chernivtsi, 58013, Ukraine
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Dnipropetrovsk, 49102, Ukraine
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Sumy, 40005, Ukraine
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Zaporizhzhya, 69040, Ukraine
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Belfast, BT9 7AB, United Kingdom
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Grimsby, DN33 2BA, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SW10 9NH, United Kingdom
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Manchester, M2O 4BX, United Kingdom
Related Publications (1)
Koeppen H, Yu W, Zha J, Pandita A, Penuel E, Rangell L, Raja R, Mohan S, Patel R, Desai R, Fu L, Do A, Parab V, Xia X, Januario T, Louie SG, Filvaroff E, Shames DS, Wistuba I, Lipkind M, Huang J, Lazarov M, Ramakrishnan V, Amler L, Phan SC, Patel P, Peterson A, Yauch RL. Biomarker analyses from a placebo-controlled phase II study evaluating erlotinib+/-onartuzumab in advanced non-small cell lung cancer: MET expression levels are predictive of patient benefit. Clin Cancer Res. 2014 Sep 1;20(17):4488-98. doi: 10.1158/1078-0432.CCR-13-1836. Epub 2014 Mar 31.
PMID: 24687921DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ivor Caro, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2011
First Posted
October 20, 2011
Study Start
January 1, 2012
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
November 2, 2016
Record last verified: 2016-11