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Spots Global Cancer Trial Database for 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)

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Medical Director

Affiliation: Merck Sharp & Dohme LLC

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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