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

This study is currently recruiting participants.
Verified April 2014 by Genentech
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01456325
First received: October 18, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: onartuzumab [MetMAb]
Drug: erlotinib [Tarceva]
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Overall survival [ Time Frame: time from randomization to death due to any cause, up to approximately 40 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival, tumor assessments according to RECIST criteria [ Time Frame: time between date of randomization and the date of first documented disease progression or death, whichever occurs first, up to approximately 40 months ] [ Designated as safety issue: No ]
  • Overall response rate (complete response + partial response) [ Time Frame: up to approximately 40 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 40 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 490
Study Start Date: July 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: onartuzumab [MetMAb]
Repeating intravenous dose
Drug: erlotinib [Tarceva]
Repeating oral dose
Active Comparator: B Drug: erlotinib [Tarceva]
Repeating oral dose
Drug: Placebo
Repeating intravenous dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 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 IHC
  • Results of 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; patients 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 patient 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 HIV infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456325

Contacts
Contact: Reference Study ID Number: GO27761 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Arizona
Completed
Chandler, Arizona, United States, 85224
United States, California
Recruiting
Hayward, California, United States, 94545
Terminated
Modesto, California, United States, 95355
Recruiting
Oakland, California, United States, 94611
Recruiting
Orange, California, United States, 92868
Recruiting
Roseville, California, United States, 95661
Completed
Sacramento, California, United States, 95825
Completed
Sacramento, California, United States, 95817
Completed
San Diego, California, United States, 92108
Recruiting
San Francisco, California, United States, 94115
Terminated
San Francisco, California, United States, 94115
Completed
San Jose, California, United States, 95119
Recruiting
Santa Clara, California, United States, 95051
Recruiting
South San Francisco, California, United States, 94080
Active, not recruiting
Vallejo, California, United States, 94589
Recruiting
Walnut Creek, California, United States, 94596
United States, Florida
Completed
Boca Raton, Florida, United States, 33486
Completed
Clearwater, Florida, United States, 33761
Completed
Fort Myers, Florida, United States, 33901
Active, not recruiting
Jacksonville, Florida, United States, 32256
Completed
Jacksonville, Florida, United States, 32207
United States, Illinois
Completed
Chicago, Illinois, United States, 60637
Completed
Urbana, Illinois, United States, 61801
United States, Iowa
Active, not recruiting
Bettendorf, Iowa, United States, 52722
Terminated
Sioux City, Iowa, United States, 51101
United States, Kentucky
Completed
Louisville, Kentucky, United States, 40207
United States, Maryland
Completed
Annapolis, Maryland, United States, 21401
Completed
Baltimore, Maryland, United States, 21237
Terminated
Baltimore, Maryland, United States, 21231
Terminated
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Completed
Boston, Massachusetts, United States, 02115
Completed
Boston, Massachusetts, United States, 02114
Terminated
Springfield, Massachusetts, United States, 01107
United States, Michigan
Completed
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
Terminated
Duluth, Minnesota, United States, 55805
United States, Missouri
Completed
St. Louis, Missouri, United States, 63110
United States, Nebraska
Completed
Omaha, Nebraska, United States, 68114
United States, Nevada
Terminated
Reno, Nevada, United States, 89502
United States, New Mexico
Terminated
Farmington, New Mexico, United States, 87401
United States, New York
Completed
Syracuse, New York, United States, 13210
United States, North Carolina
Completed
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Completed
Canton, Ohio, United States, 44718
Completed
Cleveland, Ohio, United States, 44106
Completed
Columbus, Ohio, United States, 43210
Completed
Columbus, Ohio, United States, 43219
United States, Pennsylvania
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Recruiting
Philadelphia, Pennsylvania, United States, 19104
Completed
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Terminated
Charleston, South Carolina, United States, 29403
Completed
Columbia, South Carolina, United States, 29210
United States, Tennessee
Terminated
Bristol, Tennessee, United States, 37620
Completed
Chattanooga, Tennessee, United States, 37404
Completed
Knoxville, Tennessee, United States, 37909
Completed
Nashville, Tennessee, United States, 37203
United States, Texas
Completed
Dallas, Texas, United States, 75390
Completed
Fort Worth, Texas, United States, 76104
Recruiting
Houston, Texas, United States, 77030
Completed
Houston, Texas, United States, 77030
United States, Virginia
Completed
Roanoke, Virginia, United States, 24014
Argentina
Terminated
La Plata, Argentina, B1900BAJ
Completed
Quilmes, Argentina, 1878
Recruiting
Santa Fe, Argentina, S3000FFU
Australia, New South Wales
Active, not recruiting
Camperdown, New South Wales, Australia, 2050
Active, not recruiting
Newcastle, New South Wales, Australia, 2298
Australia, Queensland
Active, not recruiting
Chermside, Queensland, Australia, 4032
Australia, South Australia
Terminated
Adelaide, South Australia, Australia, 5041
Australia, Victoria
Active, not recruiting
Parkville, Victoria, Australia, 3050
Belgium
Completed
Bruxelles, Belgium, 1200
Completed
Gent, Belgium, 9000
Active, not recruiting
Gilly, Belgium, 6060
Terminated
Liège, Belgium, 4000
Completed
Namur, Belgium, 5000
Brazil
Terminated
Salvador/BA, BA, Brazil, 41820-021
Terminated
Lajeado, RS, Brazil, 95900-000
Terminated
Novo Hamburgo, RS, Brazil, 93510-250
Terminated
Jau, SP, Brazil, 17210-080
Terminated
Sao Paulo, SP, Brazil, 08270-070
Terminated
Sorocaba, SP, Brazil, 18030-005
Canada, New Brunswick
Active, not recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Terminated
Sault Ste Marie, Ontario, Canada, P6A 2C4
Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Terminated
Montreal, Quebec, Canada, J4B 5Z7
Active, not recruiting
Montreal, Quebec, Canada, H3A 1A1
Chile
Terminated
Santiago, Chile, Providencia
Completed
Santiago, Chile, 0
Active, not recruiting
Temuco, Chile, 4810469
Croatia
Completed
Cakovec, Croatia, 40000
Terminated
Dubrovnik, Croatia, 20000
Completed
Pula, Croatia, 52100
Active, not recruiting
Zagreb, Croatia, 10000
France
Terminated
Besancon, France, 25030
Terminated
Caen, France, 14076
Completed
Grenoble, France, 38 043
Completed
Limoges, France, 87042
Active, not recruiting
Marseille, France, 13915
Active, not recruiting
Montpellier, France, 34295
Active, not recruiting
Paris, France, 75970
Terminated
Poitiers, France, 86021
Completed
Saint Herblain, France, 44805
Completed
Suresnes, France, 92151
Completed
Vandoeuvre-les-nancy, France, 54511
Germany
Terminated
Bad Berka, Germany, 99437
Completed
Berlin, Germany, 14165
Active, not recruiting
Grosshansdorf, Germany, 22927
Completed
Hamburg, Germany, 21075
Completed
Heidelberg, Germany, 69126
Completed
Karlsruhe, Germany, 76137
Completed
Mainz, Germany, 55131
Completed
München, Germany, 80336
Completed
Oldenburg, Germany, 26121
Completed
Regensburg, Germany, 93053
Active, not recruiting
Ulm, Germany, 89081
Completed
Villingen-Schwenningen, Germany, 78052
Hong Kong
Terminated
Hong Kong, Hong Kong
Completed
Pokfulam, Hong Kong
Hungary
Active, not recruiting
Edeleny, Hungary, 3780
Completed
Miskolc, Hungary, 3529
Terminated
Szombathely, Hungary, 9700
Ireland
Completed
Cork, Ireland
Terminated
Dublin, Ireland, 8
Israel
Active, not recruiting
Beer Sheva, Israel, 8410101
Completed
Haifa, Israel, 34354
Terminated
Jerusalem, Israel, 91031
Terminated
Jerusalem, Israel, 91120-01
Completed
Kfar-Saba, Israel, 4428164
Completed
Petach Tikva, Israel, 49100
Active, not recruiting
Ramat Gan, Israel, 52620-00
Terminated
Rehovot, Israel, 76100
Italy
Completed
Aviano, Friuli-Venezia Giulia, Italy, 33081
Active, not recruiting
Genova, Liguria, Italy, 16132
Active, not recruiting
Milan, Lombardia, Italy, 20141
Active, not recruiting
Monza, Lombardia, Italy, 20052
Active, not recruiting
Rozzano, Lombardia, Italy, 20089
Completed
Ancona, Marche, Italy, 60121
Active, not recruiting
Orbassano, Piemonte, Italy, 10043
Completed
Lido Di Camaiore, Toscana, Italy, 55043
Active, not recruiting
Perugia, Umbria, Italy, 06123
Japan
Active, not recruiting
Aichi, Japan, 464-8681
Terminated
Fukuoka, Japan, 812-8582
Active, not recruiting
Fukuoka, Japan, 811-1395
Active, not recruiting
Hyogo, Japan, 650-0047
Completed
Hyogo, Japan, 673-8558
Terminated
Kanagawa, Japan, 236-0051
Terminated
Kashiwa, Japan, 277-8577
Completed
Kyoto, Japan, 606-8507
Active, not recruiting
Matsuyama, Japan, 791-0280
Active, not recruiting
Miyagi, Japan, 981-1293
Active, not recruiting
Okayama, Japan, 700-8558
Recruiting
Okayama, Japan, 710-8602
Completed
Osaka, Japan, 589-8511
Active, not recruiting
Osaka, Japan, 591-8555
Active, not recruiting
Osaka, Japan, 534-0021
Active, not recruiting
Osaka, Japan, 537-8511
Active, not recruiting
Saitama, Japan, 362-0806
Terminated
Sendai-shi, Japan, 980-8574
Active, not recruiting
Shizuoka, Japan, 411-8777
Completed
Tokyo, Japan, 160-0023
Active, not recruiting
Tokyo, Japan, 104-0045
Active, not recruiting
Tokyo, Japan, 113-8677
Completed
Tokyo, Japan, 173-8605
Active, not recruiting
Tokyo, Japan, 135-8550
Active, not recruiting
Ube, Japan, 775-0241
Korea, Republic of
Completed
Gyeonggi-do, Korea, Republic of, 443-380
Completed
Seoul, Korea, Republic of, 120-752
Completed
Seoul, Korea, Republic of, 137-701
Terminated
Seoul, Korea, Republic of, 138-736
Netherlands
Completed
Amsterdam, Netherlands, 1081 HV
Active, not recruiting
Groningen, Netherlands, 9713 GZ
Completed
Maastricht, Netherlands, 6229 HX
Peru
Terminated
Lima, Peru, Lima 27
Terminated
Lima, Peru, Lima 1
Terminated
Lima, Peru, L27
Poland
Active, not recruiting
Gdansk, Poland, 80-952
Terminated
Krakow, Poland, 31-531
Completed
Lodz, Poland, 93-509
Active, not recruiting
Olsztyn, Poland, 10-357
Completed
Poznan, Poland
Russian Federation
Completed
Ivanovo, Russian Federation, 153040
Terminated
Krasnodar, Russian Federation, 350040
Terminated
Omsk, Russian Federation, 644013
Completed
St Petersburg, Russian Federation, 197089
Completed
St. Petersburg, Russian Federation, 197022
Completed
St. Petersburg, Russian Federation, 189646
Terminated
Tomsk, Russian Federation, 634050
Serbia
Completed
Belgrade, Serbia, 11080
Completed
Belgrade, Serbia, 11000
Active, not recruiting
Kragujevac, Serbia, 34000
South Africa
Completed
Bloemfontein, South Africa, 9301
Active, not recruiting
Johannesburg, South Africa, 2193
Active, not recruiting
Sandton, South Africa, 2196
Spain
Completed
Sabadell, Barcelona, Barcelona, Spain, 08208
Active, not recruiting
Barcelona, Spain, 08035
Terminated
Barcelona, Spain, 08916
Active, not recruiting
Barcelona, Spain, 08036
Active, not recruiting
Barcelona, Spain, 08041
Active, not recruiting
Madrid, Spain, 28041
Active, not recruiting
Madrid, Spain, 28034
Active, not recruiting
Madrid, Spain, 28222
Completed
Madrid, Spain, 28050
Recruiting
Sevilla, Spain, 41013
Terminated
Valencia, Spain, 41014
Taiwan
Terminated
Changhua, Taiwan, 500
Terminated
Kaohsiung, Taiwan, 813
Active, not recruiting
Taipei, Taiwan, 100
Ukraine
Terminated
Cherkassy, Ukraine, 18009
Terminated
Chernivtsi, Ukraine, 58013
Completed
Dnipropetrovsk, Ukraine, 49102
Completed
Sumy, Ukraine, 40005
Completed
Zaporizhzhya, Ukraine, 69040
United Kingdom
Terminated
Belfast, United Kingdom, BT9 7AB
Completed
Grimsby, United Kingdom, DN33 2BA
Terminated
Leicester, United Kingdom, LE1 5WW
Active, not recruiting
London, United Kingdom, SE1 9RT
Completed
London, United Kingdom, SW10 9NH
Completed
Manchester, United Kingdom, M2O 4BX
Sponsors and Collaborators
Genentech
Hoffmann-La Roche
Investigators
Study Director: Holger Thurm, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01456325     History of Changes
Other Study ID Numbers: OAM4971g, GO27761, 2011-002224-40
Study First Received: October 18, 2011
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014