Spots Global Cancer Trial Database for Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
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Trial Identification
Brief Title: Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
Official Title: A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50%
Study ID: NCT06170788
Conditions
Study Description
Brief Summary: The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130), Burbank, California, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106), Marietta, Georgia, United States
The University of Louisville, James Graham Brown Cancer Center ( Site 0121), Louisville, Kentucky, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115), Minneapolis, Minnesota, United States
Hattiesburg Clinic Hematology/Oncology ( Site 0104), Hattiesburg, Mississippi, United States
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134), Reno, Nevada, United States
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117), Corvallis, Oregon, United States
Oncology Consultants P.A. ( Site 0129), Houston, Texas, United States
Hospital Aleman-Oncology ( Site 0300), Buenos Aires, Caba, Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0304), Ciudad autónoma de Buenos Aires, Caba, Argentina
Centro Privado de RMI Río Cuarto S.A. II ( Site 0310), Río Cuarto, Cordoba, Argentina
Instituto de Oncología de Rosario ( Site 0301), Rosario, Santa Fe, Argentina
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002), Port Macquarie, New South Wales, Australia
Westmead Hospital-Department of Medical Oncology ( Site 3000), Westmead, New South Wales, Australia
Grampians Health-Medical Oncology ( Site 3001), Ballarat Central, Victoria, Australia
Northern Hospital ( Site 3003), Epping, Victoria, Australia
Clinica Universidad Catolica del Maule-Oncology ( Site 0501), Talca, Maule, Chile
Orlandi Oncologia-Oncology ( Site 0504), Santiago, Region M. De Santiago, Chile
FALP-UIDO ( Site 0509), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 0507), Santiago, Region M. De Santiago, Chile
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3100), Beijing, Beijing, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (, Guangzhou, Guangdong, China
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3113), Wuxi, Jiangsu, China
The Second People's Hospital of Neijiang ( Site 3140), Neijiang, Sichuan, China
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 3114), Taizhou, Zhejiang, China
Regionshospitalet Gødstrup-Kræftklinikken ( Site 1204), Herning, Midtjylland, Denmark
Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1201), Aalborg, Nordjylland, Denmark
Odense Universitetshospital ( Site 1200), Odense, Syddanmark, Denmark
Hôpital Saint Joseph-ONCOLOGY ( Site 1308), Marseille, Bouches-du-Rhone, France
Institut Régional du Cancer Montpellier-Medical Oncology ( Site 1309), Montpellier, Herault, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané, Limoges, Limousin, France
Centre d'Oncologie de Gentilly ( Site 1301), Nancy, Meurthe-et-Moselle, France
Centre Hospitalier de la Côte Basque ( Site 1300), Bayonne, Pyrenees-Atlantiques, France
L HOPITAL NORD OUEST ( Site 1310), Gleize, Rhone, France
Clinique de l'Europe-Service de pneumologie ( Site 1304), Amiens, Somme, France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1806), Roma, , Italy
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3800), Suwon-si, Kyonggi-do, Korea, Republic of
Ajou University Hospital-Hematology-Oncology ( Site 3806), Suwon-si, Kyonggi-do, Korea, Republic of
ETZ Elisabeth-Department of Pulmonary Diseases ( Site 1902), Tilburg, Noord-Brabant, Netherlands
Hospital Jerez de la Frontera-UGC Oncología ( Site 2333), Jerez de la Frontera, Cadiz, Spain
CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2335), A Coruña, La Coruna, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2331), Pozuelo de Alarcon, Madrid, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 2330), Barcelona, , Spain
Chang Gung Memorial Hospital at Kaohsiung ( Site 3902), Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Chi Mei Hospital - Liouying Branch ( Site 3908), Tainan City, Tainan, Taiwan
National Taiwan University Hospital - Hsinchu branch ( Site 3901), Hsinchu, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3904), Kaohsiung, , Taiwan
Taichung Veterans General Hospital-Chest ( Site 3905), Taichung, , Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3903), Tainan, , Taiwan
Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 4001), Chiang Mai, , Thailand
Medipol Mega Universite Hastanesi-oncology ( Site 2508), Stanbul, Istanbul, Turkey
Erciyes University ( Site 2511), Talas, Kayseri, Turkey
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2507), Adana, , Turkey
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501), Ankara, , Turkey
Memorial Ankara Hastanesi-Medical Oncology ( Site 2505), Ankara, , Turkey
Ankara Bilkent Şehir Hastanesi ( Site 2500), Ankara, , Turkey
Ondokuz Mayıs Universitesi ( Site 2509), Samsun, , Turkey
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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