A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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)
Study 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%.
Eligibility
Primary outcome measure(s)
- Overall Survival(OS) — Through Database Cutoff Date (Up to approximately 39 months)
OS is defined as the time from randomization to death due to any cause. - Progression-Free Survival(PFS) by investigator(INV) — Through Database Cutoff Date (Up to approximately 39 months)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1
Trial sites (62)
| Facility | City | Region | Status |
|---|---|---|---|
| The first affiliated hospital of bengbu medical college | Bengbu | Anhui | |
| Anhui provincial hospital | Hefei | Anhui | |
| Anhui provincial cancer hospital | Hefei | Anhui | |
| The first affiliated hospital of wannan medical college | Wuhu | Anhui | |
| Cancer hospital, Chinese academy of medical sciences and Peking union medical college | Beijing | Beijing Municipality | |
| The Fifth Medical Center of the Chinese People's Liberation Army General Hospital | Beijing | Beijing Municipality | |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | |
| Beijing Chest hospital | Beijing | Beijing Municipality | |
| Chongqing University Cancer Hospital | Chongqing | Chongqing Municipality | |
| Fujian cancer hospital | Fuzhou | Fujian | |
| Zhangzhou municipal hospital of fujian province | Zhangzhou | Fujian | |
| Gansu provincial cancer hospital | Lanzhou | Gansu | |
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | |
| Affiliated cancer hospital and institute of guangzhou medical university | Guangzhou | Guangdong | |
| Nanfang hospital | Guangzhou | Guangdong | |
| Cancer hospital Chinses academy of medical sciences, shenzhen center | Shenzhen | Guangdong | |
| Hainan cancer hospital | Haikou | Hainan | |
| Affiliated hospital of Hebei university | Baoding | Hebei | |
| The second people's hospital of Hengshui | Hengshui | Hebei | |
| The Second Hospital of HeBei Medical University | Shijiazhuang | Hebei | |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | |
| Tangshang people's hospital | Tangshan | Hebei | |
| Harbin medical university cancer hospital | Harbin | Heilongjiang | |
| Jiamusi Tuberculosis Prevention and Control Hospital (Jiamusi Cancer Hospital) | Jiamusi | Heilongjiang | |
| The first hospital of Qiqihar | Qiqihar | Heilongjiang | |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | |
| Nanyang central hospital | Nanyang | Henan | |
| The First Affiliated Hospital of Xinxiang Medical College | Xinxiang | Henan | |
| Henan Cancer Hospital | Zhengzhou | Henan | |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | |
| Hubei Cancer Hospital | Wuhan | Hubei | |
| Xiangya Hospital of Central South University | Changsha | Hunan | |
| The Second Xiangya Hospital, Central South University | Changsha | Hunan | |
| Hunan Cancer Hospital | Changsha | Hunan | |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | |
| The affiliated hospital of xuzhou medical university | Xuzhou | Jiangsu | |
| First Affiliated Hospital of Gannan medical college | Ganzhou | Jiangxi | |
| First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | |
| The first hospital of Jilin Universit | Changchun | Jilin |
+ 22 more sites — see the full list on the official registry below.
More Akeso trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05990127 on ClinicalTrials.gov ↗ ← All trials in China