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Trial record 1 of 1 for:    cell lung cancer AND maryland AND metmab
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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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01456325
First received: October 18, 2011
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

This randomized, multicenter, double-blind, placebo-controlled study will evalua te the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva ( erlotinib) in patients with incurable non-small cell lung cancer identified to b e Met diagnostic-positive. Patients will be randomized to receive either onartuz umab (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: Placebo
Drug: erlotinib [Tarceva]
Drug: onartuzumab [MetMAb]
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, Inc.:

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 ]

Enrollment: 499
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: erlotinib [Tarceva]
Repeating oral dose
Drug: onartuzumab [MetMAb]
Repeating intravenous dose
Other Name: PRO143966
Active Comparator: B Drug: Placebo
Repeating intravenous dose
Drug: erlotinib [Tarceva]
Repeating oral 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456325

  Hide Study Locations
Locations
United States, Arizona
Chandler, Arizona, United States, 85224
United States, 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, 95825
Sacramento, California, United States, 95817
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
United States, 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
United States, Illinois
Chicago, Illinois, United States, 60637
Urbana, Illinois, United States, 61801
United States, Iowa
Bettendorf, Iowa, United States, 52722
Sioux City, Iowa, United States, 51101
United States, Kentucky
Louisville, Kentucky, United States, 40207
United States, Maryland
Annapolis, Maryland, United States, 21401
Baltimore, Maryland, United States, 21237
Baltimore, Maryland, United States, 21201
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02114
Springfield, Massachusetts, United States, 01107
United States, Michigan
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
Duluth, Minnesota, United States, 55805
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, Nevada
Reno, Nevada, United States, 89502
United States, New Mexico
Farmington, New Mexico, United States, 87401
United States, New York
Syracuse, New York, United States, 13210
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Canton, Ohio, United States, 44718
Cleveland, Ohio, United States, 44106
Columbus, Ohio, United States, 43210
Columbus, Ohio, United States, 43219
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Charleston, South Carolina, United States, 29403
Columbia, South Carolina, United States, 29210
United States, Tennessee
Bristol, Tennessee, United States, 37620
Chattanooga, Tennessee, United States, 37404
Knoxville, Tennessee, United States, 37909
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas, Texas, United States, 75390
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77030
United States, Virginia
Roanoke, Virginia, United States, 24014
Argentina
La Plata, Argentina, B1900BAJ
Quilmes, Argentina, 1878
Santa Fe, Argentina, S3000FFU
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Newcastle, New South Wales, Australia, 2298
Australia, Queensland
Chermside, Queensland, Australia, 4032
Australia, South Australia
Adelaide, South Australia, Australia, 5041
Australia, Victoria
Parkville, Victoria, Australia, 3050
Belgium
Bruxelles, Belgium, 1200
Gent, Belgium, 9000
Gilly, Belgium, 6060
Liège, Belgium, 4000
Namur, Belgium, 5000
Brazil
Salvador/BA, BA, Brazil, 41820-021
Lajeado, RS, Brazil, 95900-000
Novo Hamburgo, RS, Brazil, 93510-250
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
Canada, Ontario
Sault Ste Marie, Ontario, Canada, P6A 2C4
Toronto, Ontario, Canada, M5G 2M9
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal, Quebec, Canada, J4B 5Z7
Montreal, Quebec, Canada, H3A 1A1
Chile
Santiago, Chile, Providencia
Santiago, Chile, 0
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
Hong Kong, Hong Kong
Pokfulam, 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, 9372212
Jerusalem, Israel, 91120-01
Kfar-Saba, Israel, 4428164
Petach Tikva, Israel, 49100
Ramat Gan, Israel, 52620-00
Rehovot, Israel, 76100
Italy
Aviano, Friuli-Venezia Giulia, Italy, 33081
Genova, Liguria, Italy, 16132
Milan, Lombardia, Italy, 20141
Monza, Lombardia, Italy, 20052
Rozzano, Lombardia, Italy, 20089
Ancona, Marche, Italy, 60121
Orbassano, Piemonte, Italy, 10043
Lido Di Camaiore, Toscana, Italy, 55043
Perugia, Umbria, Italy, 06123
Japan
Aichi, Japan, 464-8681
Fukuoka, Japan, 811-1395
Fukuoka, Japan, 812-8582
Hyogo, Japan, 673-8558
Hyogo, Japan, 650-0047
Kanagawa, Japan, 236-0051
Kashiwa, Japan, 277-8577
Kyoto, Japan, 606-8507
Matsuyama, Japan, 791-0280
Miyagi, Japan, 981-1293
Okayama, Japan, 700-8558
Okayama, Japan, 710-8602
Osaka, Japan, 589-8511
Osaka, Japan, 591-8555
Osaka, Japan, 534-0021
Osaka, Japan, 537-8511
Saitama, Japan, 362-0806
Sendai-shi, Japan, 980-8574
Shizuoka, Japan, 411-8777
Tokyo, Japan, 135-8550
Tokyo, Japan, 104-0045
Tokyo, Japan, 113-8677
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, 138-736
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 137-701
Netherlands
Amsterdam, Netherlands, 1081 HV
Groningen, Netherlands, 9700 RB
Maastricht, Netherlands, 6229 HX
Peru
Lima, Peru, Lima 1
Lima, Peru, Lima 27
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, 189646
St. Petersburg, Russian Federation, 197022
Tomsk, Russian Federation, 634050
Serbia
Belgrade, Serbia, 11080
Belgrade, Serbia, 11000
Kragujevac, Serbia, 34000
South Africa
Bloemfontein, South Africa, 9301
Johannesburg, South Africa, 2193
Sandton, South Africa, 2196
Spain
Sabadell, Barcelona, Barcelona, Spain, 08208
Barcelona, Spain, 08035
Barcelona, Spain, 08041
Barcelona, Spain, 08036
Barcelona, Spain, 08916
Madrid, Spain, 28050
Madrid, Spain, 28034
Madrid, Spain, 28222
Madrid, Spain, 28007
Sevilla, Spain, 41013
Valencia, Spain, 41014
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
Sponsors and Collaborators
Genentech, Inc.
Hoffmann-La Roche
Investigators
Study Director: Holger Thurm, M.D. Genentech, Inc.
  More Information

No publications provided by Genentech, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01456325     History of Changes
Other Study ID Numbers: OAM4971g, GO27761, 2011-002224-40
Study First Received: October 18, 2011
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014