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A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)
Sponsor: Klus Pharma Inc.
Summary
The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.
Official title: A Phase II Study of SKB264 as Monotherapy or as Combination Therapy in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
356
Start Date
2023-04-19
Completion Date
2026-12-30
Last Updated
2026-01-27
Healthy Volunteers
No
Conditions
Interventions
SKB264
intravenous (IV) infusion (Q2W or Q3W)
Pembrolizumab
intravenous (IV) infusion (400mg, Q6W)
Carboplatin
intravenous (IV) infusion (AUC5, Q3W)
Osimertinib
80mg, QD
Locations (50)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital (Chongqing Cancer Hospital)
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yatsen University Cancer Center Huangpu Hos
Guangzhou, Guangdong, China
Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University(Heyi Compus)
Zhengzhou, Henan, China
Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Hospital of Chinese Medical University(Heping Compus)
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
ISR-GEO Med Res Clin Healthycore
Tbilisi, Georgia
LLC "Todua Clinic"
Tbilisi, Georgia
Ltd New Hospitals
Tbilisi, Georgia
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Sf. Nectarie
Craiova, Dolj, Romania
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggido, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitario QuirónSalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Micancer Center S.L.P.
Barcelona, Spain
Hospital Universitari Dexeus Grupo Quironsalud
Barcelona, Spain
Hospital Universitari Vall D Hebron
Barcelona, Spain
Hospital Quironsalud Malaga
Málaga, Spain
Hospital Universitario Virgen de Valme
Seville, Spain
Hospital Clinico Universitario De Valencia
Valencia, Spain
Medical Park Seyhan Hospital
Adana, Turkey (Türkiye)
Adana City Training and Research Hospital
Adana, Turkey (Türkiye)
Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
Ankara, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, Turkey (Türkiye)