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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
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:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, 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
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR