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A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer
Sponsor: Akeso
Summary
This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS \< 1%.
Official title: A Randomized, Double-blind, Phase III Trial to Compare the Efficacy and Safety of AK104 Combined With Chemotherapy to Tislelizumab Combined With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer (NSCLC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
642
Start Date
2023-11-14
Completion Date
2026-11-28
Last Updated
2023-08-14
Healthy Volunteers
No
Conditions
Interventions
AK104
AK104 IV, q3w
Tislelizumab
Tislelizumab IV, q3w
carboplatin
carboplatin IV, q3w
Pemetrexed
Pemetrexed IV, q3w (for Nonsquamous NSCLC)
Paclitaxel
Paclitaxel IV, q3w (for squamous NSCLC)
Locations (62)
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Anhui provincial hospital
Hefei, Anhui, China
Anhui provincial cancer hospital
Hefei, Anhui, China
The first affiliated hospital of wannan medical college
Wuhu, Anhui, China
Cancer hospital, Chinese academy of medical sciences and Peking union medical college
Beijing, Beijing Municipality, China
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Chest hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian cancer hospital
Fuzhou, Fujian, China
Zhangzhou municipal hospital of fujian province
Zhangzhou, Fujian, China
Gansu provincial cancer hospital
Lanzhou, Gansu, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Affiliated cancer hospital and institute of guangzhou medical university
Guangzhou, Guangdong, China
Nanfang hospital
Guangzhou, Guangdong, China
Cancer hospital Chinses academy of medical sciences， shenzhen center
Shenzhen, Guangdong, China
Hainan cancer hospital
Haikou, Hainan, China
Affiliated hospital of Hebei university
Baoding, Hebei, China
The second people's hospital of Hengshui
Hengshui, Hebei, China
The Second Hospital of HeBei Medical University
Shijiazhuang, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tangshang people's hospital
Tangshan, Hebei, China
Harbin medical university cancer hospital
Harbin, Heilongjiang, China
Jiamusi Tuberculosis Prevention and Control Hospital (Jiamusi Cancer Hospital)
Jiamusi, Heilongjiang, China
The first hospital of Qiqihar
Qiqihar, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang central hospital
Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The affiliated hospital of xuzhou medical university
Xuzhou, Jiangsu, China
First Affiliated Hospital of Gannan medical college
Ganzhou, Jiangxi, China
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The first hospital of Jilin Universit
Changchun, Jilin, China
Tonghua Central Hospital
Tonghua, Jilin, China
The First Hospital of China medical University
Shenyang, Liaoning, China
Liaoning cancer hospital
Shenyang, Liaoning, China
General hospital of ningxia medical university
Yinchuan, Ningxia, China
Qinghai university affiliated hospital
Xining, Qinghai, China
Binzhou medical university hospital
Binzhou, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weifang NO.2 people's Hospital
Weifang, Shandong, China
Zhongshan Hospital, Fudan university
Shanghai, Shanghai Municipality, China
Changzhi people's hospital
Changzhi, Shanxi, China
Shanxi Cancer hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Mianyang central hospital
Mianyang, Sichuan, China
The Second People's Hospital of Yibin City
Yibin, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital /the Third Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China