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
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
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 hypothesis is that sacituzumab tirumotecan is superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
Jacksonville, Florida 32224, United States
Marietta, Georgia 30060, United States
Rochester, Minnesota 55905, United States
Morristown, New Jersey 07960, United States
Cincinnati, Ohio 45219, United States
Melbourne, Victoria 3021, Australia
Natal, Rio Grande do Norte 59075-740, Brazil
Porto Alegre, Rio Grande do Sul 91350-200, Brazil
São Paulo, 01246-000, Brazil
Beijing, Beijing Municipality 100142, China
Beijing, Beijing Municipality 100730, China
Chongqing, Chongqing Municipality 400030, China
Guangzhou, Guangdong 510515, China
Nanning, Guangxi 530200, China
Harbin, Heilongjiang 150000, China
Nangjing, Jiangsu 210008, China
Nanchang, Jiangxi 330006, China
Xi'an, Shaanxi 710061, China
Shanghai, Shanghai Municipality 200030, China
Shanghai, Shanghai Municipality 200032, China
Chengdu, Sichuan 610041, China
Hangzhou, Zhejiang 310016, China
Brno, Brno-mesto 656 53, Czechia
Ostrava, Ostrava Mesto 703 00, Czechia
Olomouc, 779 00, Czechia
Bordeaux, Aquitaine 33076, France
Lyon Cedex08, Auvergne-Rhône-Alpes 69373, France
Rouen, Haute-Normandie 76031, France
Freiburg, Brandenburg 79106, Germany
Göttingen, Lower Saxony 37075, Germany
Essen, North Rhine-Westphalia 45136, Germany
Athens, Attica 115 26, Greece
Athens, Attica 115 27, Greece
Chaidari, Athens, Attica 124 62, Greece
Thessaloniki, Central Macedonia 540 07, Greece
Hksar, Hong Kong
Meldola, Emilia-Romagna 47014, Italy
Rome, Lazio 00168, Italy
Milan, Lombardy 20133, Italy
Otashi, Gunma 373-8550, Japan
Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777, Japan
Koto, Tokyo 135-8550, Japan
Kota Bharu, Kelantan 15586, Malaysia
Putrajaya, Kuala Lumpur 62250, Malaysia
Monterrey, Nuevo León 66460, Mexico
Iloilo City, Iloilo 5000, Philippines
Manila, National Capital Region 1000, Philippines
Muntinlupa, National Capital Region 1780, Philippines
Pasig, National Capital Region 1604, Philippines
San Juan City, Metro Manila, National Capital Region 1502, Philippines
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
Torun, Kuyavian-Pomeranian Voivodeship 87-100, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Przemyśl, Podkarpackie Voivodeship 37-700, Poland
Gliwice, Silesian Voivodeship 44-102, Poland
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Hwasun, Jeonranamdo 58128, South Korea
Suwon, Kyonggi-do 16247, South Korea
Yangsan, Kyongsangnam-do 50612, South Korea
Cheongju-si, North Chungcheong 28644, South Korea
Seoul, 03722, South Korea
Barcelona, Catalonia 08036, Spain
Las Palmas de Gran Canaria, Las Palmas 35016, Spain
Pozuelo de Alarcón, Madrid 28223, Spain
Madrid, Madrid, Comunidad de 28009, Spain
Barcelona, 08035, Spain
Taipei City, Taipei 106, Taiwan
Muang, Changwat Lampang 52000, Thailand
Muang, Chiang Mai 50200, Thailand
Stanbul, Istanbul 34214, Turkey (Türkiye)
Bornova, İzmir 35100, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
London, London, City of EC1A 7BE, United Kingdom
London, London, City of SE1 9RT, United Kingdom
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom