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Brief Title: A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)
Official Title: A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer
Study ID: NCT03322566
Brief Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Southern Cancer Center, PC, Daphne, Alabama, United States
Western Regional Medical Center, Inc., Goodyear, Arizona, United States
Arizona Oncology Associates PC- HOPE, Tucson, Arizona, United States
Lynn Cancer Institute, Boca Raton, Florida, United States
Florida Cancer Specialists (South Region), Fort Myers, Florida, United States
Florida Cancer Specialists (North Region), Saint Petersburg, Florida, United States
PPG-Oncology, Fort Wayne, Indiana, United States
University of Michigan, Ann Arbor, Michigan, United States
MMCORC, Saint Louis Park, Minnesota, United States
St. Vincent Healthcare Frontier Cancer Center, Billings, Montana, United States
New York Oncology Hematology P.C, Albany, New York, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
Southwestern Regional Medical Center, Inc., Tulsa, Oklahoma, United States
St. Luke's Hospital - Anderson Campus, Easton, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute, Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology-Denton South, Denton, Texas, United States
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care, Blacksburg, Virginia, United States
Emily Couric Clinical Cancer Center, Charlottesville, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
MNCCI Port Macquarie Base Hospital, Port Macquarie, New South Wales (Australia), Australia
Blacktown Hospital, Blacktown, New South Wales, Australia
Chris OBrien Lifehouse, Camperdown, New South Wales, Australia
The Crown Princess Mary Cancer Centre Westmead, Westmead, New South Wales, Australia
Southern Medical Day Care Centre, Wollongong, New South Wales, Australia
Cairns Base Hospital, Cairns, Queensland, Australia
BCCA-Cancer Centre of the Southern Interior, Kelowna, British Columbia, Canada
Lions Gate Hospital, North Vancouver, British Columbia, Canada
CISSS de la Monteregie-Centre, Greenfield Park, Quebec, Canada
CSSS de Laval- Hopital de la Cite de la Sante, Laval, Quebec, Canada
CIUSSS Ouest de l'Ile - St-Mary's Hospital, Montréal, Quebec, Canada
CIUSSS du Nord-de-l'ILe-de-Montreal Hopital du Sacre-Coeur de Montreal, Montréal, Quebec, Canada
CIUSSS de la Mauricie-et-du-Centre-du-Quebec, Trois-Rivières, Quebec, Canada
CHU de Quebec - Hotel-Dieu de Quebec, Quebec, , Canada
Zala Megyei Korhaz Pozvai Telephely, Pozva, Zalaegerszeg, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest, , Hungary
Veszprem Megyei Tudogyogyintezet, Farkasgyepű, , Hungary
Bekes Megyei Pandy Kalman Korhaz, Gyula, , Hungary
CRU Hungary Kft., Miskolc, , Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet, Szolnok, , Hungary
St Vincents University Hospital, Dublin, , Ireland
Ha Emek Medical Center, Afula, , Israel
Soroka Medical Center, Be'er Sheva, , Israel
Rambam Medical Center, Haifa, , Israel
Meir Medical Center, Kfar Saba, , Israel
Rabin Medical Center, Petah Tikva, , Israel
Chaim Sheba Medcal Center, Ramat Gan, , Israel
Centro Di Riferimento Oncologico, Aviano, , Italy
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico, Catania, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Ospedale San Gerardo - ASST Monza, Monza, , Italy
National Cancer Center, Goyang-si, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Medical Care Research S.A. de C.V., Mérida, Yucatan, Mexico
Oaxaca Site Management Organization S.C., Oaxaca, , Mexico
FAICIC Clinical Research, Veracruz, , Mexico
Belgorod Regional Oncology Dispensary, Belgorod, , Russian Federation
Udmurtia Republic Regional Clinical Oncology Dispensary, Izhevsk, , Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH, Kazan, , Russian Federation
Central Clinical Hospital with polyclinic, Moscow, , Russian Federation
Moscow Research Oncology Institute, Moscow, , Russian Federation
SBI of Stavropol region Pyatigorskiy Oncologic dispensary, Pyatigorsk, , Russian Federation
SBHI Leningrad Regional Clinical Hospital, Saint Petersburg, , Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary, Samara, , Russian Federation
Oncological Dispensary #2 of Ministry of Health of Krasnodar region, Sochi, , Russian Federation
Tomsk Scientific Research Institute of Oncology, Tomsk, , Russian Federation
Hospital Universitario Insular de Gran Canaria, Las Palmas De Gran Canaria, Gran Canaria, Spain
Hospital Juan Ramón Jimenez, Huelva, , Spain
Institut Catala Oncologia de Bellvitge - ICO, L'Hospitalet De Llobregat, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain
Chang Gung Medical Foundation, Kaohsiung Branch, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation, Linkou Branch, Taoyuan, , Taiwan
Ege Universitesi Tip Fakultesi Hastanesi, İzmir, Bornova, Turkey
Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi, Adana, , Turkey
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi, Adana, , Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara, , Turkey
Uludag Universitesi Tip Fakultesi, Bursa, , Turkey
Pamukkale Unv. Tip Fak, Denizli, , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul, , Turkey
Samsun Medical Park Hastanesi, Samsun, , Turkey
Namık Kemal University Medical Faculty, Tekirdağ, , Turkey
Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
North Middlesex Hospital, London, , United Kingdom
Freeman Hospital Newcastle upon Tyne Foundation NHS Trust, Newcastle Upon Tyne, , United Kingdom
Name: Lance Leopold, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR