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A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Summary
The study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.
Official title: A Randomized, Open-Label, Multicenter Phase 3 Clinical Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
432
Start Date
2024-10-30
Completion Date
2028-12
Last Updated
2026-07-08
Healthy Volunteers
No
Conditions
Interventions
SKB264
IV Infusion
Pembrolizumab
IV Infusion
pemetrexed
IV Infusion
carboplatin or cisplatin
IV Infusion
Locations (81)
Beijing Cancer Hospital
Beijing, China
Beijing Chest Hospital. Capital Medical University
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking University Third Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
Jilin Cancer Hospital
Changcun, China
Hunan Cancer Hospital
Changsha, China
Xiangya Hospital, Central South University
Changsha, China
Xiangya Second Hospital of Central South University
Changsha, China
Chengdu Fifth People's Hospital
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
The General Hospital of Western Theater Command
Chengdu, China
University of Electronic Science and Technology of China, Sichuan Cancer Hospital and Institute & Cancer, The Second People's Hospital of Sichuan Province
Chengdu, China
West China Hospital of Sichuan University
Chengdu, China
Army Medical Center of PLA (Daping Hospital)
Chongqing, China
Chongqing University Cancer Hospital
Chongqing, China
The Second Affiliated Hospital of Army Medical University
Chongqing, China
The Southwest Hospial Of AMU
Chongqing, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
Fujian Cancer Hospital
Fuzhou, China
The 900 Hospital of the Joint Logistics Support Force of the People's Liberation Army of China
Fuzhou, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Affiliated Hospital of Guilin Medical University
Guilin, China
Sir Run Run Shaw Hospital (SRRSH)
Hangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Ha’erbin, China
The 2nd Affiliated Hospital of Harbin Medical University
Ha’erbin, China
Anhui Provincial Chest Hospital
Hefei, China
The Second Affiliated Hospital Of Anhui Medical University
Hefei, China
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, China
Shandong Provincial Hospital
Jinan, China
The Third Affiliated Hospital of Kunming Medical University
Kunming, China
Gansu Provincial Cancer Hospital
Lanzhou, China
Linyi Cancer Hospital
Linyi, China
The First Affiliated Hospital of Henan University of Science & Technology,
Luoyang, China
Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China
Mianyang, China
Jiangxi Cancer Hospital
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, China
Jiangsu Cancer Hospital
Nanjing, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Guangxi Medical University Cancer Hospital
Nanning, China
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
The Second People's Hospital of Neijiang
Neijiang, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Huashan Hospital Affiliated to Fudan University
Shanghai, China
Shanghai Chest Hospital
Shanghai, China
Shanghai Oriental Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
Zhongshan Hospital of Fudan University
Shanghai, China
Yuebei People's Hospital
Shaoguan, China
Shengjing Hospital, China Medical University
Shengyang, China
China Medical University First Affiliated Hospital
Shenyang, China
Liaoning Cancer Hospital
Shenyang, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Shanxi Province Cancer Hospital
Taiyuan, China
Taizhou Hospital of Zhejiang Province
Taizhou, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, China
Weifang People's Hospital
Weifang, China
Hubei Cancer Hospital
Wuhan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Zhongnan Hospital of Wuhan University
Wuhan, China
The First Affiliated Hospital of XiAn Jiaotong University
Xi'an, China
The Second Affiliated Hospital of XiAn Jiaotong University
Xi'an, China
The First Affiliated Hospital Of Xiamen University
Xiamen, China
Xiangyang Central Hospital
Xiangyang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
Yibin Second People's Hospital
Yibin, China
General Hospital of Ningxia Medical University
Yinchuan, China
Henan Cancer Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
The Second Affiliated Hospital Of Zunyi Medical University
Zunyi, China