Spots Global Cancer Trial Database for Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)
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Trial Identification
Brief Title: Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)
Official Title: A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)
Study ID: NCT03515837
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib \[TAGRISSO®\] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars-Sinai Medical Center ( Site 0070), Los Angeles, California, United States
Pacific Cancer Care ( Site 0058), Monterey, California, United States
UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092), Orange, California, United States
St. Joseph Heritage Healthcare ( Site 0003), Santa Rosa, California, United States
North Shore University Health System ( Site 0030), Evanston, Illinois, United States
Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065), Sioux City, Iowa, United States
Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048), Edina, Minnesota, United States
Saint Lukes Hospital of Kansas City ( Site 0060), Kansas City, Missouri, United States
New York Oncology Hematology P.C ( Site 8000), Albany, New York, United States
Monter Cancer Center ( Site 0054), Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049), New York, New York, United States
White Plains Hospital Center for Cancer Care ( Site 0014), White Plains, New York, United States
Providence Portland Medical Center ( Site 0097), Portland, Oregon, United States
Kaiser Permanente Northwest ( Site 0037), Portland, Oregon, United States
Parkland Health & Hospital System ( Site 2102), Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas ( Site 0035), Dallas, Texas, United States
Utah Cancer Specialists ( Site 0001), Salt Lake City, Utah, United States
Emily Couric Clinical Cancer Center ( Site 0020), Charlottesville, Virginia, United States
Froedtert Hospital & the Medical College of Wisconsin ( Site 0041), Milwaukee, Wisconsin, United States
Chris OBrien Lifehouse ( Site 0200), Camperdown, New South Wales, Australia
Westmead Hospital ( Site 0201), Westmead, New South Wales, Australia
Eastern Health ( Site 0202), Box Hill, Victoria, Australia
Austin Health ( Site 0203), Heidelberg, Victoria, Australia
Liga Norte Riograndense Contra o Cancer ( Site 1909), Natal, Rio Grande Do Norte, Brazil
Hospital de Caridade de Ijui ( Site 1907), Ijui, Rio Grande Do Sul, Brazil
Hospital Bruno Born ( Site 1913), Lajeado, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre ( Site 1905), Porto Alegre, Rio Grande Do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1904), Porto Alegre, Rio Grande Do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1911), Barretos, Sao Paulo, Brazil
Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1912), Ribeirao Preto, Sao Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1903), Sao Paulo, , Brazil
William Osler Health System ( Site 0100), Brampton, Ontario, Canada
Sunnybrook Health Sciences, Odette Cancer Centre ( Site 0102), Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0104), Toronto, Ontario, Canada
Jewish General Hospital ( Site 0105), Montreal, Quebec, Canada
The First Affiliated Hospital of Anhui Medical University ( Site 0721), Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 0717), Beijing, Beijing, China
Peking Union Medical College Hospital ( Site 0703), Beijing, Beijing, China
Beijing Cancer Hospital ( Site 0718), Beijing, Beijing, China
Southwest Hospital, The Third Military Medical University ( Site 0725), Chongqing, Chongqing, China
Fujian Cancer Hospital ( Site 0723), Fuzhou, Fujian, China
The Affiliated Tumour Hospital of Harbin Medical University ( Site 0706), Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 0711), Zhengzhou, Henan, China
Xiangya Hospital of Central South University ( Site 0710), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0722), Changsha, Hunan, China
Jiangsu Cancer Hospital ( Site 0719), Nanjing, Jiangsu, China
The First Hospital of Jilin University ( Site 0702), Chang chun, Jilin, China
Jilin Cancer Hospital ( Site 0705), Changchun, Jilin, China
Shanghai Chest Hospital ( Site 0700), Shanghai, Shanghai, China
Zhongshan Hospital Fudan University ( Site 0712), Shanghai, Shanghai, China
Tangdu Hospital ( Site 0708), XI An, Shanxi, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0709), XI An, Shanxi, China
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0701), Urumqi, Xinjiang, China
The First Affiliated Hospital.Zhejiang University ( Site 0713), Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital School of Medicine, Zhejiang University ( Site 0715), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0716), Hangzhou, Zhejiang, China
Centre Leon Berard ( Site 0801), Lyon, Auvergne, France
CHU Caen Service de Pneumologie ( Site 0804), Caen, Calvados, France
Centre Georges Francois Leclerc ( Site 0809), Dijon, Cote-d'Or, France
Hopital Jean Minjoz Besancon ( Site 0805), Besancon, Doubs, France
Hopital Prive d'Antony ( Site 0811), Antony, Hauts-de-Seine, France
C.H.U. de Tours - Hopital Bretonneau ( Site 0806), Tours, Indre-et-Loire, France
Centre D Oncologie de Gentilly ( Site 0810), Nancy, Meurthe-et-Moselle, France
Clinique Victor Hugo ( Site 0802), Le Mans, Sarthe, France
CHU Poitiers ( Site 0803), Poitiers, Vienne, France
Robert Bosch Krankenhaus Klinik Schillerhoehe ( Site 0904), Gerlingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Mannheim ( Site 0911), Mannheim, Baden-Wurttemberg, Germany
Klinikum Wuerzburg Mitte gGmbH ( Site 0901), Wuerzburg, Bayern, Germany
Pius Hospital Oldenburg ( Site 0905), Oldenburg, Niedersachsen, Germany
Florence Nightingale Krankenhaus ( Site 0912), Duesseldorf, Nordrhein-Westfalen, Germany
Kliniken Essen-Mitte ( Site 0900), Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Muenster ( Site 0906), Muenster, Nordrhein-Westfalen, Germany
Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0907), Dresden, Sachsen, Germany
Asklepios Klinikum Hamburg ( Site 0908), Hamburg, , Germany
Hong Kong Integrated Oncology Centre ( Site 0304), Hong Kong, , Hong Kong
Queen Mary Hospital ( Site 0301), Hong Kong, , Hong Kong
Queen Mary Hospital ( Site 0303), Hong Kong, , Hong Kong
Hong Kong United Oncology Centre ( Site 0306), Kowloon, , Hong Kong
Tuen Mun Hospital ( Site 0305), Tuen Mun, , Hong Kong
Barzilai Medical Center ( Site 1706), Ashkelon, HaDarom, Israel
Soroka Medical Center ( Site 1702), Beer-Sheva, HaDarom, Israel
Meir Medical Center ( Site 1701), Kfar-Saba, HaMerkaz, Israel
Rabin Medical Center ( Site 1704), Petah Tikva, HaMerkaz, Israel
Ha Emek Medical Center ( Site 1707), Afula, HaTsafon, Israel
Rambam Medical Center ( Site 1703), Haifa, Heifa, Israel
Chaim Sheba Medical Center. ( Site 1700), Ramat Gan, Tell Abib, Israel
Sourasky Medical Center ( Site 1705), Tel Aviv, Tell Abib, Israel
Istituto Europeo di Oncologia ( Site 1303), Milano, Lombardia, Italy
Ospedale San Vincenzo di Taormina ( Site 1302), Taormina, Messina, Italy
AOU San Luigi Gonzaga di Orbassano ( Site 1300), Orbassano, Torino, Italy
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1305), Bari, , Italy
Azienda Ospedaliero Universitaria Careggi ( Site 1301), Firenze, , Italy
Azienda Ospedaliera dei Colli V. Monaldi ( Site 1306), Napoli, , Italy
Universita Campus Bio-Medico di Roma ( Site 1304), Roma, , Italy
National Hospital Organization Nagoya Medical Center ( Site 0608), Nagoya, Aichi, Japan
Aichi Cancer Center Hospital ( Site 0612), Nagoya, Aichi, Japan
Fujita Health University Hospital ( Site 0619), Toyoake, Aichi, Japan
National Cancer Center Hospital East ( Site 0601), Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0616), Matsuyama, Ehime, Japan
Hyogo Cancer Center ( Site 0604), Akashi, Hyogo, Japan
Kanazawa University Hospital ( Site 0617), Kanazawa, Ishikawa, Japan
Kanagawa Cancer Center ( Site 0609), Yokohama, Kanagawa, Japan
Kansai Medical University Hospital ( Site 0606), Hirakata, Osaka, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0602), Sunto-gun, Shizuoka, Japan
National Hospital Organization Kyushu Medical Center ( Site 0621), Fukuoka, , Japan
Kyushu University Hospital ( Site 0605), Fukuoka, , Japan
Niigata Cancer Center Hospital ( Site 0610), Niigata, , Japan
Okayama University Hospital ( Site 0614), Okayama, , Japan
Osaka International Cancer Institute ( Site 0611), Osaka, , Japan
National Cancer Center Hospital ( Site 0603), Tokyo, , Japan
Toranomon Hospital ( Site 0615), Tokyo, , Japan
Tokyo Metropolitan Komagome Hospital ( Site 0618), Tokyo, , Japan
Wakayama Medical University Hospital ( Site 0613), Wakayama, , Japan
Chungbuk National University Hospital ( Site 0404), Cheongju si, Chungcheongbuk-do [Chungbuk], Korea, Republic of
Gachon University Gil Medical Center ( Site 0408), Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of
National Cancer Center ( Site 0400), Gyeonggi-do, Kyonggi-do, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0405), Seongnam-si, Kyonggi-do, Korea, Republic of
Seoul National University Hospital ( Site 0402), Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Asan Medical Center ( Site 0407), Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center ( Site 0403), Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0406), Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Ulsan University Hospital ( Site 0401), Ulsan, Ulsan-Kwangyokshi, Korea, Republic of
Instituto Jaliscience de Cancerologia ( Site 2000), Guadalajara, Jalisco, Mexico
Medica Sur S.A.B de C.V. ( Site 2003), Mexico City, , Mexico
Oaxaca Site Management Organization SC ( Site 2001), Oaxaca, , Mexico
Instituto Nacional de Cancerologia. ( Site 2007), Tlalpan, , Mexico
Hospitalo Univ. Germans Trias i Pujol ( Site 1100), Badalona, Barcelona [Barcelona], Spain
Hospital de la Santa Creu i Sant Pau ( Site 1102), Barcelona, Barcelona [Barcelona], Spain
Hospital Universitari Vall d Hebron ( Site 1106), Barcelona, Barcelona [Barcelona], Spain
Hospital Ramon y Cajal ( Site 1101), Madrid, , Spain
Hospital Universitario 12 de Octubre ( Site 1103), Madrid, , Spain
Complejo Hospitalario Carlos Haya de Malaga ( Site 1107), Malaga, , Spain
Hospital Universitario Virgen Macarena ( Site 1104), Sevilla, , Spain
Linkopings Universitetssjukhus ( Site 1504), Linkoping, Ostergotlands Lan [se-05], Sweden
Skanes Universitetssjukhus Lund ( Site 1503), Lund, Skane Lan [se-12], Sweden
Karolinska Universitetssjukhuset Solna ( Site 1500), Solna, Stockholms Lan [se-01], Sweden
Sahlgrenska Universitetssjukhuset ( Site 1502), Goteborg, Vastra Gotalands Lan [se-14], Sweden
Taipei Tzu Chi Hospital ( Site 0512), New Taipei City, New Taipei, Taiwan
Changhua Christian Hospital ( Site 0509), Changhua, , Taiwan
National Taiwan University Hospital Hsin-Chu Branch ( Site 0511), Hsinchu, , Taiwan
Hualien Tzu Chi Medical Center-Hospital ( Site 0510), Hualien, , Taiwan
Kaohsiung Chang Gung Memorial Hospital ( Site 0507), Kaohsiung, , Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 0508), New Taipei, , Taiwan
China Medical University Hospital ( Site 0505), Taichung, , Taiwan
Taichung Veterans General Hospital ( Site 0504), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 0506), Tainan, , Taiwan
National Taiwan University Hospital ( Site 0500), Taipei, , Taiwan
Mackay Memorial Hospital ( Site 0503), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 0501), Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0502), Taoyuan, , Taiwan
Sussex University Hospitals ( Site 1003), Brighton, Brighton And Hove, United Kingdom
Western General Hospital ( Site 1009), Edinburgh, Edinburgh, City Of, United Kingdom
Leicester Royal Infirmary ( Site 1000), Leicester, Leicestershire, United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 1006), London, London, City Of, United Kingdom
Chelsea & Westminster Hospital ( Site 1001), London, London, City Of, United Kingdom
Birmingham Heartlands Hospital ( Site 1002), Birmingham, , United Kingdom
St James s University Hospital ( Site 1008), Leeds, , United Kingdom
Barking Havering and Redbridge University Hospitals NHS Trust Queen s Hospital ( Site 1004), Romford, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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