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)
NCT ID: NCT01456325
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
494 participants
INTERVENTIONAL
2012-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Erlotinib
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
Onartuzumab (MetMab)
Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.
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.
Erlotinib
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
Placebo
Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.
Interventions
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Erlotinib
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
Onartuzumab (MetMab)
Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.
Placebo
Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ivor Caro, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Chandler, Arizona, United States
Hayward, California, United States
Modesto, California, United States
Oakland, California, United States
Orange, California, United States
Roseville, California, United States
Sacramento, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
San Jose, California, United States
Santa Clara, California, United States
South San Francisco, California, United States
Vallejo, California, United States
Walnut Creek, California, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
Urbana, Illinois, United States
Bettendorf, Iowa, United States
Sioux City, Iowa, United States
Louisville, Kentucky, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Ann Arbor, Michigan, United States
Duluth, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Reno, Nevada, United States
Farmington, New Mexico, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Canton, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Bristol, Virginia, United States
Roanoke, Virginia, United States
La Plata, , Argentina
Quilmes, , Argentina
Santa Fe, , Argentina
Camperdown, New South Wales, Australia
Waratah, New South Wales, Australia
Chermside, Queensland, Australia
Adelaide, South Australia, Australia
Parkville, Victoria, Australia
Brussels, , Belgium
Ghent, , Belgium
Gilly (Charleroi), , Belgium
Liège, , Belgium
Namur, , Belgium
Salvador/BA, Estado de Bahia, Brazil
Lajeado, Rio Grande do Sul, Brazil
Novo Hamburgo, Rio Grande do Sul, Brazil
Jaú, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Sorocaba, São Paulo, Brazil
Saint John, New Brunswick, Canada
Sault Ste. Marie, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Santiago, , Chile
Santiago, , Chile
Temuco, , Chile
Čakovec, , Croatia
Dubrovnik, , Croatia
Pula, , Croatia
Zagreb, , Croatia
Besançon, , France
Caen, , France
Grenoble, , France
Limoges, , France
Marseille, , France
Montpellier, , France
Paris, , France
Poitiers, , France
Saint-Herblain, , France
Suresnes, , France
Vandœuvre-lès-Nancy, , France
Bad Berka, , Germany
Berlin, , Germany
Großhansdorf, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Karlsruhe, , Germany
Mainz, , Germany
München, , Germany
Oldenburg, , Germany
Regensburg, , Germany
Ulm, , Germany
Villingen-Schwenningen, , Germany
Pokfulam, , Hong Kong
Shatin, , Hong Kong
Edelény, , Hungary
Miskolc, , Hungary
Szombathely, , Hungary
Cork, , Ireland
Dublin, , Ireland
Beersheba, , Israel
Haifa, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Aviano, Friuli Venezia Giulia, Italy
Genoa, Liguria, Italy
Milan, Lombardy, Italy
Monza, Lombardy, Italy
Rozzano, Lombardy, Italy
Orbassano, Piedmont, Italy
Ancona, The Marches, Italy
Lido di Camaiore, Tuscany, Italy
Perugia, Umbria, Italy
Aichi, , Japan
Chiba, , Japan
Ehime, , Japan
Fukuoka, , Japan
Fukuoka, , Japan
Hyōgo, , Japan
Hyōgo, , Japan
Kanagawa, , Japan
Kyoto, , Japan
Miyagi, , Japan
Miyagi, , Japan
Okayama, , Japan
Okayama, , Japan
Osaka, , Japan
Osaka, , Japan
Osaka, , Japan
Osaka, , Japan
Saitama, , Japan
Shizuoka, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Yamaguchi, , Japan
Amsterdam, , Netherlands
Groningen, , Netherlands
Maastricht, , Netherlands
Lima, , Peru
Lima, , Peru
Lima, , Peru
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Olsztyn, , Poland
Poznan, , Poland
Ivanovo, , Russia
Krasnodar, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Tomsk, , Russia
Belgrade, , Serbia
Belgrade, , Serbia
Kragujevac, , Serbia
Bloemfontein, , South Africa
Johannesburg, , South Africa
Sandton, , South Africa
Gyeonggi-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Sabadell, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain
Changhua, , Taiwan
Kaohsiung City, , Taiwan
Taipei, , Taiwan
Cherkassy, , Ukraine
Chernivtsi, , Ukraine
Dnipropetrovsk, , Ukraine
Sumy, , Ukraine
Zaporizhzhya, , Ukraine
Belfast, , United Kingdom
Grimsby, , United Kingdom
Leicester, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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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.
Other Identifiers
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GO27761
Identifier Type: OTHER
Identifier Source: secondary_id
2011-002224-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OAM4971g
Identifier Type: -
Identifier Source: org_study_id