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Brief Title: A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
Official Title: A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
Study ID: NCT06312137
Brief Summary: This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mid Florida Hematology and Oncology Center ( Site 0018), Orange City, Florida, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027), Minneapolis, Minnesota, United States
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037), Reno, Nevada, United States
Queen Mary Hospital ( Site 3400), Hksar, , Hong Kong
Rambam Health Care Campus-Oncology Division ( Site 2203), Haifa, , Israel
Shaare Zedek Medical Center ( Site 2206), Jerusalem, , Israel
Rabin Medical Center ( Site 2204), Petah Tikva, , Israel
Sheba Medical Center ( Site 2200), Ramat Gan, , Israel
Chungbuk National University Hospital-Internal medicine ( Site 1000), Cheongju-si, Chungbuk, Korea, Republic of
National Cancer Center-Lung Cancer Center ( Site 1002), Goyang-si, Kyonggi-do, Korea, Republic of
Keimyung University Dongsan Hospital CRC room 1 ( Site 1006), Daegu, Taegu-Kwangyokshi, Korea, Republic of
Samsung Medical Center-Division of Hematology/Oncology ( Site 1004), Seoul, , Korea, Republic of
Kantonsspital Graubünden-Medizin ( Site 3006), Chur, Grisons, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1103), Kaohsiung, , Taiwan
Taichung Veterans General Hospital-Chest ( Site 1101), Taichung, , Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 1102), Tainan, , Taiwan
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR