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Brief Title: Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)
Official Title: A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants
Study ID: NCT03739710
Brief Summary: This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC. Drug name mentioned as GSK4428859A (belrestotug) and EOS884448 are interchangeable for the same compound and will be referred to as GSK4428859A/EOS884448/belrestotug.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, Saint Louis, Missouri, United States
GSK Investigational Site, Bronx, New York, United States
GSK Investigational Site, Bronx, New York, United States
GSK Investigational Site, Pinehurst, North Carolina, United States
GSK Investigational Site, Chattanooga, Tennessee, United States
GSK Investigational Site, Nashville, Tennessee, United States
GSK Investigational Site, Dallas, Texas, United States
GSK Investigational Site, Edmonton, Alberta, Canada
GSK Investigational Site, Brampton, Ontario, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Bordeaux Cedex, , France
GSK Investigational Site, Caen Cedex 9, , France
GSK Investigational Site, Nantes cedex 1, , France
GSK Investigational Site, Paris Cedex 05, , France
GSK Investigational Site, Paris, , France
GSK Investigational Site, Villejuif Cedex, , France
GSK Investigational Site, Heidelberg, Baden-Wuerttemberg, Germany
GSK Investigational Site, Gauting, Bayern, Germany
GSK Investigational Site, Immenhausen, Hessen, Germany
GSK Investigational Site, Kassel, Hessen, Germany
GSK Investigational Site, Leipzig, Sachsen, Germany
GSK Investigational Site, Grosshansdorf, Schleswig-Holstein, Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Napoli, Campania, Italy
GSK Investigational Site, Meldola (FC), Emilia-Romagna, Italy
GSK Investigational Site, Ravenna, Emilia-Romagna, Italy
GSK Investigational Site, Milano, Lombardia, Italy
GSK Investigational Site, Orbassano (TO), Piemonte, Italy
GSK Investigational Site, Siena, Toscana, Italy
GSK Investigational Site, Cheongju-si, Chungcheongbuk-do, , Korea, Republic of
GSK Investigational Site, Gyeonggi-do, , Korea, Republic of
GSK Investigational Site, Seongnam, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Amsterdam, , Netherlands
GSK Investigational Site, Maastricht, , Netherlands
GSK Investigational Site, Lodz, , Poland
GSK Investigational Site, Poznan, , Poland
GSK Investigational Site, Warszawa, , Poland
GSK Investigational Site, Bucharest, , Romania
GSK Investigational Site, Craiova, , Romania
GSK Investigational Site, Floresti, , Romania
GSK Investigational Site, Otopeni, , Romania
GSK Investigational Site, Timisoara, , Romania
GSK Investigational Site, Chelyabinsk, , Russian Federation
GSK Investigational Site, Saint-Petersburg, , Russian Federation
GSK Investigational Site, Saint-Petersburg, , Russian Federation
GSK Investigational Site, Badajoz, , Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Málaga, , Spain
GSK Investigational Site, Santander, , Spain
GSK Investigational Site, Sevilla, , Spain
GSK Investigational Site, Solna, , Sweden
GSK Investigational Site, Uppsala, , Sweden
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR