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Brief Title: Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)
Official Title: A Biomarker-directed Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Whose Disease Has Progressed on First-Line Osimertinib Therapy.
Study ID: NCT03944772
Brief Summary: Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.
Detailed Description: This is an open-label, multicentre, multi-drug, biomarker-directed Phase 2 platform study in patients with advanced non-small cell lung cancer (NSCLC) harbouring an epidermal growth factor receptor (EGFR)-sensitizing mutation whose disease has progressed on first-line monotherapy with osimertinib.Treatment options for these patients are limited. Novel treatments for these patients are urgently required. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Duarte, California, United States
Research Site, Los Angeles, California, United States
Research Site, Sacramento, California, United States
Research Site, Santa Monica, California, United States
Research Site, New Haven, Connecticut, United States
Research Site, Chicago, Illinois, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Boston, Massachusetts, United States
Research Site, Grand Rapids, Michigan, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, Portland, Oregon, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Houston, Texas, United States
Research Site, Seattle, Washington, United States
Research Site, Odense C, , Denmark
Research Site, Catania, , Italy
Research Site, Napoli, , Italy
Research Site, Orbassano, , Italy
Research Site, Padova, , Italy
Research Site, Varese, , Italy
Research Site, Chuo-ku, , Japan
Research Site, Fukuoka-shi, , Japan
Research Site, Koto-ku, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Wakayama-shi, , Japan
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Amsterdam, , Netherlands
Research Site, Amsterdam, , Netherlands
Research Site, Maastricht, , Netherlands
Research Site, Nijmegen, , Netherlands
Research Site, Rotterdam, , Netherlands
Research Site, Drammen, , Norway
Research Site, Oslo, , Norway
Research Site, Trondheim, , Norway
Research Site, A Coruña, , Spain
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Sevilla, , Spain
Research Site, Stockholm, , Sweden
Name: Helena A Yu, MD
Affiliation: Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA
Role: PRINCIPAL_INVESTIGATOR