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Brief Title: Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
Official Title: A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations
Study ID: NCT06074588
Brief Summary: The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mid Florida Hematology and Oncology Center ( Site 0005), Orange City, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003), Marietta, Georgia, United States
Hattiesburg Clinic Hematology/Oncology ( Site 0010), Hattiesburg, Mississippi, United States
Capital Health Medical Center - Hopewell ( Site 0006), Pennington, New Jersey, United States
St. George Private Hospital ( Site 3004), Kogarah, New South Wales, Australia
Westmead Hospital-Department of Medical Oncology ( Site 3000), Westmead, New South Wales, Australia
Monash Health-Oncology Research ( Site 3001), Clayton, Victoria, Australia
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003), Melbourne, Victoria, Australia
William Osler Health System ( Site 0205), Brampton, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0204), Toronto, Ontario, Canada
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
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0502), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 0507), Santiago, Region M. De Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 0500), Viña del Mar, Valparaiso, Chile
Chongqing University Cancer Hospital-Medical Oncology ( Site 2814), Chongqing, Chongqing, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (, Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital-Respiratory Oncology ( Site 2816), Nanning, Guangxi, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 2805), Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 2809), Wuhan, Hubei, China
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817), Xi'an, Shaanxi, China
Shanghai Chest Hospital-Oncology department ( Site 2800), Shanghai, Shanghai, China
Yunnan Province Cancer Hospital ( Site 2824), Kunming, Yunnan, China
Hong Kong Integrated Oncology Centre ( Site 3200), Central, , Hong Kong
Queen Mary Hospital ( Site 3203), Hksar, , Hong Kong
Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204), Kowloon, , Hong Kong
Princess Margaret Hospital-Department of Oncology ( Site 3201), Lai Chi Kok, , Hong Kong
Rambam Health Care Campus-Oncology Division ( Site 1702), Haifa, , Israel
Shaare Zedek Medical Center ( Site 1700), Jerusalem, , Israel
Rabin Medical Center ( Site 1703), Petah Tikva, , Israel
Chungbuk National University Hospital-Internal medicine ( Site 3809), Cheongju-si, Chungbuk, Korea, Republic of
Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807), Hwasun, Jeonranamdo, Korea, Republic of
National Cancer Center-Lung Cancer Center ( Site 3810), Goyang-si, Kyonggi-do, Korea, Republic of
Seoul National University Bundang Hospital ( Site 3806), Seongnam, Kyonggi-do, Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3803), Suwon-si, Kyonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3811), Yangsan, Kyongsangnam-do, Korea, Republic of
Pusan National University Hospital ( Site 3805), Busan, Pusan-Kwangyokshi, Korea, Republic of
Chungnam national university hospital ( Site 3808), Jung-gu, Taejon-Kwangyokshi, Korea, Republic of
Kangbuk Samsung Hospital ( Site 3813), Seoul, , Korea, Republic of
Konkuk University Medical Center ( Site 3812), Seoul, , Korea, Republic of
Asan Medical Center ( Site 3801), Seoul, , Korea, Republic of
Samsung Medical Center-Division of Hematology/Oncology ( Site 3802), Seoul, , Korea, Republic of
Korea University Guro Hospital-Internal Medicine ( Site 3800), Seoul, , Korea, Republic of
National Cancer Institute-Radiotherapy and Oncology ( Site 3504), Putrajaya, Kuala Lumpur, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 3500), Kuching, Sarawak, Malaysia
Changhua Christian Hospital ( Site 3908), Changhua County, Changhua, Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 3906), Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Chi Mei Medical Center ( Site 3910), Tainan City, Tainan, Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 3903), Taipei City, Taipei, Taiwan
National Taiwan University Hospital - Hsinchu branch ( Site 3907), Hsinchu, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3912), Kaohsiung, , Taiwan
E-Da hospital ( Site 3911), Kaohsiung, , Taiwan
National Cheng Kung University Hospital ( Site 3909), Tainan, , Taiwan
National Taiwan University Hospital-Oncology ( Site 3904), Taipei, , Taiwan
Mackay Memorial Hospital-Chest Medicine ( Site 3902), Taipei, , Taiwan
Taipei Medical University Hospital ( Site 3900), Taipei, , Taiwan
Maharaj Nakorn Chiang Mai Hospital ( Site 4003), Chiang Mai, , Thailand
Faculty of Medicine - Khon Kaen University ( Site 4004), Khon Kaen, , Thailand
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR