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Spots Global Cancer Trial Database for Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)

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Trial Identification

Brief Title: Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)

Official Title: Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center, Two-Part Study of Patritumab (U3-1287) In Combination With Erlotinib in EGFR Wild-type Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Systemic Therapy

Study ID: NCT02134015

Study Description

Brief Summary: 1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin. 2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.

Detailed Description:

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, Glendale, Arizona, United States

, Duarte, California, United States

, La Verne, California, United States

, Los Angeles, California, United States

, San Francisco, California, United States

, Port Saint Lucie, Florida, United States

, Tampa, Florida, United States

, Chicago, Illinois, United States

, Maywood, Illinois, United States

, Goshen, Indiana, United States

, Louisville, Kentucky, United States

, Grand Rapids, Michigan, United States

, Saint Cloud, Minnesota, United States

, Saint Louis, Missouri, United States

, Las Vegas, Nevada, United States

, Columbus, Ohio, United States

, Bend, Oregon, United States

, Portland, Oregon, United States

, Redmond, Oregon, United States

, Chattanooga, Tennessee, United States

, Knoxville, Tennessee, United States

, Nashville, Tennessee, United States

, Dallas, Texas, United States

, Salt Lake City, Utah, United States

, Arlington, Virginia, United States

, Seattle, Washington, United States

, Brasschaat, Antwerpen, Belgium

, Bruxelles, Brussels, Belgium

, Charleroi, Hainaut, Belgium

, Charleroi, , Belgium

, Gent, , Belgium

, Liege, , Belgium

, Yvoir, , Belgium

, Hamilton, Ontario, Canada

, Kingston, Ontario, Canada

, Toronto, Ontario, Canada

, Levis, Quebec, Canada

, Montreal, Quebec, Canada

, Ostava-Poruba, , Czechia

, Ostrava-Poruba, , Czechia

, Esslingen am Neckar, Baden-Wurttemberg, Germany

, Gerlingen, Baden-Wurttemberg, Germany

, Heidelberg, Baden-Württemberg, Germany

, Ulm, Baden-Württemberg, Germany

, Villingen-Schwenningen, Baden-Württemberg, Germany

, Gauting, Bayern, Germany

, Muenchen, Bayern, Germany

, Frankfurt am Main, Hessen, Germany

, Immenhausen, Hessen, Germany

, Koln, Nordrhein-Westfalen, Germany

, Rheine, Nordrhein-Westfalen, Germany

, Mainz, Rheinland-Pfalz, Germany

, Halle, Sachsen-Anhalt, Germany

, Grosshansdorf, Schleswig-Holstein, Germany

, Gießen, , Germany

, Szekesfehervar, Fejer, Hungary

, Gyor, Gyor-Moson-Sopron, Hungary

, Szolnok, Jasz-Nagykun-Szolnok, Hungary

, Tatabanya, , Hungary

, Meldola, Forli, Italy

, Sora, Frosinone, Italy

, Lecco, Lombardia, Italy

, Benevento, , Italy

, Bologna, , Italy

, Cremona, , Italy

, Faenza, , Italy

, Genova, , Italy

, Milano, , Italy

, Napoli, , Italy

, Perugia, , Italy

, Ravenna, , Italy

, Rimini, , Italy

, Roma, , Italy

, Rozzano, , Italy

, Torun, Kujawsko-pomorskie, Poland

, Otwock, Mazowieckie, Poland

, Gdansk, Pomorskie, Poland

, Szczecin, Zachodniopomorskie, Poland

, Krakow, , Poland

, Prabuty, , Poland

, Warszawa, , Poland

, La Coruna, A Coruña, Spain

, Sevilla, Andalucia, Spain

, Valencia, Valenciana, Comunidad, Spain

, Alicante, , Spain

, Barcelona (2), , Spain

, Barcelona (3), , Spain

, Barcelona (4), , Spain

, Barcelona (5), , Spain

, Barcelona (6), , Spain

, Barcelona, , Spain

, Burgos (2), , Spain

, Burgos, , Spain

, Madrid (2), , Spain

, Madrid (3), , Spain

, Madrid (4), , Spain

, Madrid, , Spain

, Manresa (2), , Spain

, Manresa, , Spain

, Palma de Mallorca, , Spain

, Valencia, , Spain

, Zaragoza (2), , Spain

, Zaragoza, , Spain

, Stevenage, Hertfordshire, United Kingdom

, London (2), , United Kingdom

, London (3), , United Kingdom

, London, , United Kingdom

, Northwood, , United Kingdom

, Rickmansworth, , United Kingdom

, Southampton, , United Kingdom

, Wirral, , United Kingdom

Contact Details

Name: Global Clinical Leader

Affiliation: Daiichi Sankyo

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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