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ACTIVE NOT RECRUITING
NCT06448312
PHASE3

A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Official title: A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

406

Start Date

2024-06-07

Completion Date

2026-11

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

SKB264

IV Infusion

DRUG

Pembrolizumab

IV Infusion

Locations (64)

Hebei University Affiliated Hospital

Baoding, China

Beijing Chest Hospital. Capital Medical University

Beijing, China

Beijing Institute for Cancer Research

Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Jilin Cancer Hospital

Changchun, China

The First Hospital of Jilin University

Changchun, China

Hunan Cancer Hospital

Changsha, China

The Second People's Hospital of Hunan Province(Brain Hospital of Hunan Province)

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

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 Southwest Hospital Of AMU

Chongqing, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, China

Dongguan People's Hospital

Dongguan, China

Fujian Cancer Hospital

Fuzhou, China

Fujian Medical University Union Hospital

Fuzhou, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, China

Sun Yat-sen Memorial Hospital Sun Yat-sen University

Guangzhou, China

Sun Yat-sen University Cancer Center

Guangzhou, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Sir Run Run Shaw Hospital (SRRSH)

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, 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 Yunnan Cancer Hospital

Kunming, China

Gansu Provincial Cancer Hospital

Lanzhou, 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

Jiangsu Province Hospital

Nanjing, China

Guangxi Medical University Cancer Hospital

Nanning, China

People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

Shanghai Chest Hospital

Shanghai, China

Shanghai East Hospital, Tongji University

Shanghai, China

Shanghai Pulmonary Hospital

Shanghai, China

Zhongshan Hospital of Fudan University

Shanghai, China

Yuebei People's Hospital

Shaoguan, China

China Medical University First Affiliated Hospital

Shenyang, China

Liaoning Cancer Hospital

Shenyang, China

Shengjing Hospital, China Medical University

Shenyang, China

Shanxi Province Cancer Hospital

Taiyuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Hubei Cancer Hospital

Wuhan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

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

Affiliated Tumor Hospital of Xinjiang Medical University

Xinjiang, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, China

Subei People's Hospital of Jiangsu province

Yangzhou, China

Yibin Second People's Hospital

Yibin, China

The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital,Henan Academy of Innovations in Medical Science

Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

The Second Affiliated Hospital Of Zunyi Medical University

Zunyi, China