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 February 2013 by Genentech
Sponsor:
Genentech
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01456325
First received: October 18, 2011
Last updated: February 26, 2013
Last verified: February 2013
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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: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: onartuzumab [MetMAb]
Repeating intravenous dose
Other Name: PRO143966
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
Hide Study Locations
Contacts
| Contact: Please reference Study ID Number: GO27761 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
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| United States, Arizona | |
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| Chandler, Arizona, United States, 85224 | |
| United States, California | |
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| Hayward, California, United States, 94545 | |
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| Los Angeles, California, United States, 90095 | |
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| Modesto, California, United States, 95355 | |
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| Oakland, California, United States, 94611 | |
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| Orange, California, United States, 92868 | |
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| Roseville, California, United States, 95661 | |
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| Sacramento, California, United States, 95825 | |
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| Sacramento, California, United States, 95817 | |
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| San Diego, California, United States, 92108 | |
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| San Francisco, California, United States, 94115 | |
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| San Jose, California, United States, 95119 | |
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| Santa Clara, California, United States, 95051 | |
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| South San Francisco, California, United States, 94080 | |
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| Vallejo, California, United States, 94589 | |
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| Walnut Creek, California, United States, 94596 | |
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| Boca Raton, Florida, United States, 33486 | |
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| Clearwater, Florida, United States, 33761 | |
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| Fort Myers, Florida, United States, 33916 | |
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| Jacksonville, Florida, United States, 32256 | |
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| Jacksonville, Florida, United States, 32207 | |
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| Chicago, Illinois, United States, 60637 | |
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| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
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| Bettendorf, Iowa, United States, 52722 | |
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| Sioux City, Iowa, United States, 51101 | |
| United States, Kentucky | |
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| Louisville, Kentucky, United States, 40207 | |
| United States, Maryland | |
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| Annapolis, Maryland, United States, 21401 | |
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| Baltimore, Maryland, United States, 21201 | |
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| Baltimore, Maryland, United States, 21237 | |
| United States, Massachusetts | |
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| Boston, Massachusetts, United States, 02115 | |
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| Boston, Massachusetts, United States, 02114 | |
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| Springfield, Massachusetts, United States, 01107 | |
| United States, Michigan | |
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| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
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| Duluth, Minnesota, United States, 55805 | |
| United States, Missouri | |
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| St. Louis, Missouri, United States, 63110 | |
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| Omaha, Nebraska, United States, 68114 | |
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| Reno, Nevada, United States, 89502 | |
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| Farmington, New Mexico, United States, 87401 | |
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| Syracuse, New York, United States, 13210 | |
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| Canton, Ohio, United States, 44718 | |
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| Cleveland, Ohio, United States, 44106 | |
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| Columbus, Ohio, United States, 43210 | |
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| Columbus, Ohio, United States, 43219 | |
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| Philadelphia, Pennsylvania, United States, 19104 | |
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| Pittsburgh, Pennsylvania, United States, 15232 | |
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| Charleston, South Carolina, United States, 29425 | |
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| Columbia, South Carolina, United States, 29210 | |
| United States, Tennessee | |
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| Bristol, Tennessee, United States, 37620 | |
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| Chattanooga, Tennessee, United States, 37404 | |
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| Knoxville, Tennessee, United States, 37909 | |
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| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
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| Dallas, Texas, United States, 75390 | |
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| Fort Worth, Texas, United States, 76104 | |
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| Houston, Texas, United States, 77030 | |
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| Roanoke, Virginia, United States, 24014 | |
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| Córdoba, Argentina, 5000 | |
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| La Plata, Argentina, B1900BAJ | |
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| Quilmes, Argentina, 1878 | |
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| Santa Fe, Argentina, S3000FFU | |
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| Chermside, Australia, 4032 | |
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| Newcastle, Australia, 2298 | |
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| Parkville, Australia, 3050 | |
| Belgium | |
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| Bruxelles, Belgium, 1200 | |
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| Gent, Belgium, 9000 | |
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| Gilly, Belgium, 6060 | |
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| Liège, Belgium, 4000 | |
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| Namur, Belgium, 5000 | |
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| Barretos, Brazil, 14784-400 | |
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| Botucatu, Brazil, 18618-000 | |
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| JAÚ, Brazil, 17210-120 | |
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| Lajeado, Brazil, 95900-000 | |
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| Novo Hamburgo, Brazil, 93510-250 | |
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| Porto Alegre, Brazil, 90610-000 | |
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| Salvador/ba, Brazil, 41820-021 | |
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| Sao Paulo, Brazil, 04038-001 | |
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| Sao Paulo, Brazil, 01246-000 | |
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| Sao Paulo, Brazil, 08270-070 | |
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| Sorocaba, Brazil, 18030-510 | |
| Canada, New Brunswick | |
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| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Ontario | |
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| Sault Ste Marie, Ontario, Canada, P6A 2C4 | |
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| Toronto, Ontario, Canada, M5G 2M9 | |
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| Toronto, Ontario, Canada, M4N 3M5 | |
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| Montreal, Quebec, Canada, J4B 5Z7 | |
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| Montreal, Quebec, Canada, H3A 1A1 | |
| Chile | |
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| Santiago, Chile | |
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| Santiago, Chile, 664 0166 | |
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| Temuco, Chile, 4810469 | |
| Croatia | |
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| Cakovec, Croatia, 40000 | |
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| Dubrovnik, Croatia, 20000 | |
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| Pula, Croatia, 52100 | |
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| Zagreb, Croatia, 10000 | |
| France | |
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| Besancon, France, 25030 | |
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| Caen, France, 14076 | |
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| Grenoble, France, 38043 | |
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| Limoges, France, 87042 | |
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| Marseille, France, 13915 | |
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| Montpellier, France, 34295 | |
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| Paris, France, 75970 | |
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| Poitiers, France, 86021 | |
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| Saint Herblain, France, 44805 | |
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| Suresnes, France, 92151 | |
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| Vandoeuvre-les-nancy, France, 54510 | |
| Germany | |
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| Bad Berka, Germany, 99437 | |
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| Berlin, Germany, 14165 | |
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| Grosshansdorf, Germany, 22927 | |
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| Hamburg, Germany, 21075 | |
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| Heidelberg, Germany, 69126 | |
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| Karlsruhe, Germany, 76137 | |
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| München, Germany, 80336 | |
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| Oldenburg, Germany, 26121 | |
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| Regensburg, Germany, 93053 | |
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| ULM, Germany, 89081 | |
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| Villingen-schwenningen, Germany, 78050 | |
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| Hungary | |
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| Edeleny, Hungary, 3780 | |
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| Miskolc, Hungary, 3529 | |
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| Szombathely, Hungary, 9700 | |
| India | |
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| Pune, India, 411004 | |
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| Dublin, Ireland, 8 | |
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| Beer Sheva, Israel, 84101 | |
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| Haifa, Israel, 31096 | |
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| Jerusalem, Israel, 91031 | |
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| Jerusalem, Israel, 91120 | |
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| Kfar Saba, Israel, 44281 | |
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| Petach Tikva, Israel, 49100 | |
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| Ramat-gan, Israel, 52621 | |
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| Rehovot, Israel, 76100 | |
| Italy | |
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| Ancona, Italy, 60121 | |
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| Aviano, Italy, 33081 | |
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| Genova, Italy, 16132 | |
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| Lido Di Camaiore, Italy, 55043 | |
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| Milan, Italy, 20141 | |
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| Monza, Italy, 20052 | |
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| Orbassano, Italy, 10043 | |
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| Perugia, Italy, 06123 | |
| Completed | |
| Rozzano, Italy, 20089 | |
| Japan | |
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| Aichi, Japan, 464-8681 | |
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| Chuo-ku, Japan, 103-0004 | |
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| Fukuoka, Japan, 812-8582 | |
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| Fukuoka, Japan, 811-1395 | |
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| Hyogo, Japan, 673-8558 | |
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| Itabashi-ku, Japan, 173-0806 | |
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| Kanagawa, Japan, 236-0051 | |
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| Kashiwa, Japan, 277-8577 | |
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| Kyoto, Japan, 606-8507 | |
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| Matsuyama, Japan, 791-0280 | |
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| Natori, Japan, 981-1293 | |
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| Okayama, Japan, 700-8558 | |
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| Okayama, Japan, 710-8602 | |
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| Osaka, Japan, 537-8511 | |
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| Osaka, Japan, 589-8511 | |
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| Osaka, Japan, 534-0021 | |
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| Saitama, Japan, 362-0806 | |
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| Sakai, Japan, 591-8555 | |
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| Sendai-shi, Japan, 980-8574 | |
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| Shizuoka, Japan, 411-8777 | |
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| Tokyo, Japan, 104-0045 | |
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| Tokyo, Japan, 135-8550 | |
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| Tokyo, Japan, 113-8677 | |
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| Tokyo, Japan, 160-0023 | |
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| UBE, Japan, 775-0241 | |
| Korea, Republic of | |
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| Seoul, Korea, Republic of, 138-736 | |
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| Seoul, Korea, Republic of, 137-807 | |
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| Seoul, Korea, Republic of, 120-752 | |
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| Suwon City, Korea, Republic of, 443-721 | |
| Netherlands | |
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| Amsterdam, Netherlands, 1081 HV | |
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| Groningen, Netherlands, 9713 GZ | |
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| Maastricht, Netherlands, 6229 HX | |
| Peru | |
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| Lima, Peru, Lima 27 | |
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| Lima, Peru, Lima 1 | |
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| Lima, Peru, L27 | |
| Poland | |
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| Gdansk, Poland, 80-952 | |
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| Krakow, Poland, 31-531 | |
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| Lodz, Poland, 93-509 | |
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| Olsztyn, Poland, 10-357 | |
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| Poznan, Poland | |
| Russian Federation | |
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| Ivanovo, Russian Federation, 153040 | |
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| Krasnodar, Russian Federation, 350040 | |
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| Omsk, Russian Federation, 644013 | |
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| St Petersburg, Russian Federation, 197089 | |
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| St. Petersburg, Russian Federation, 197022 | |
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| St. Petersburg, Russian Federation, 189646 | |
| Terminated | |
| Tyumen, Russian Federation, 625041 | |
| Serbia | |
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| Belgrade, Serbia, 11080 | |
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| Belgrade, Serbia, 11000 | |
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| Kragujevac, Serbia, 34000 | |
| South Africa | |
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| Bloemfontein, South Africa, 9301 | |
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| Johannesburg, South Africa, 2193 | |
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| Johannesburg, South Africa, 2199 | |
| Spain | |
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| Barcelona, Spain, 08035 | |
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| Barcelona, Spain, 08041 | |
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| Barcelona, Spain, 08036 | |
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| Barcelona, Spain, 08916 | |
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| Madrid, Spain, 28007 | |
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| Madrid, Spain, 28050 | |
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| Madrid, Spain, 28034 | |
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| Madrid, Spain, 28222 | |
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| Sabadell, Barcelona, Spain, 08208 | |
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| Sevilla, Spain, 41013 | |
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| Valencia, Spain, 41014 | |
| Taiwan | |
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| Changhua, Taiwan, 500 | |
| Not yet recruiting | |
| Kaohsiung, Taiwan, 813 | |
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| Taipei, Taiwan, 100 | |
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| Taoyuan, Taiwan, 333 | |
| Ukraine | |
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| Cherkassy, Ukraine, 18009 | |
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| Chernivtsi, Ukraine, 58013 | |
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| Dnipropetrovsk, Ukraine, 49102 | |
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| Sumy, Ukraine, 40005 | |
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| Zaporizhzhya, Ukraine, 69040 | |
| United Kingdom | |
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| Belfast, United Kingdom, BT9 7AB | |
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| Grimsby, United Kingdom, DN33 2BA | |
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| Leicester, United Kingdom, LE1 5WW | |
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| London, United Kingdom, SE1 9RT | |
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| London, United Kingdom, SW10 9NH | |
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| 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: | February 26, 2013 |
| 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 May 23, 2013