A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer
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)
1 other identifier
interventional
642
1 country
62
Brief 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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
Typical duration for phase_3
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
November 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2026
ExpectedAugust 14, 2023
August 1, 2023
1.7 years
August 3, 2023
August 10, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Survival(OS)
OS is defined as the time from randomization to death due to any cause.
Through Database Cutoff Date (Up to approximately 39 months)
Progression-Free Survival(PFS) by investigator(INV)
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
Through Database Cutoff Date (Up to approximately 39 months)
Secondary Outcomes (14)
Progression-Free Survival(PFS) by Blind independent center review(BIRC)
Through Database Cutoff Date (Up to approximately 39 months)
Objective response rate (ORR) was assessed by INV
Through Database Cutoff Date (Up to approximately 39 months)
Disease control rate (DCR) was assessed by INV
Through Database Cutoff Date (Up to approximately 39 months)
Time to response (TTR) was assessed by INV
Through Database Cutoff Date (Up to approximately 39 months)
Duration of response (DOR) was assessed by INV
Through Database Cutoff Date (Up to approximately 39 months)
- +9 more secondary outcomes
Study Arms (2)
AK104 arm
EXPERIMENTALTislelizumab arm
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
- Aged ≥18 years when the subject signed the informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition).
- No prior systemic therapy for advanced or metastatic NSCLC was received.
- PD-L1 TPS \< 1%.
- No EGFR sensitive mutations or ALK gene translocation alterations.
You may not qualify if:
- Histologically confirmed small cell lung cancer (SCLC).
- NSCLC with driver gene mutations for approved targeted drug indications.
- Active central nervous system (CNS) metastases were present.
- Pulmonary radiation therapy \> 30 Gy within 6 months prior to first dose.
- Active malignant tumors within the past 5 years, except for tumors in this study and scured local tumors.
- Pregnant or lactating women.
- Clinically significant cardiovascular or cerebrovascular disease.
- Subjects with a known history of severe hypersensitivity to other monoclonal antibodies. A known history of allergy or hypersensitivity to all investigational drugs or any of their components.
- Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.
- Known active pulmonary tuberculosis.
- Patients with active hepatitis B or active hepatitis C.
- Known medical history of immunodeficiency or positive HIV test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akesolead
Study Sites (62)
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, 233099, China
Anhui provincial hospital
Hefei, Anhui, 230001, China
Anhui provincial cancer hospital
Hefei, Anhui, 230088, China
The first affiliated hospital of wannan medical college
Wuhu, Anhui, 241001, China
Cancer hospital, Chinese academy of medical sciences and Peking union medical college
Beijing, Beijing Municipality, 100021, China
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100039, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Chest hospital
Beijing, Beijing Municipality, 101149, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian cancer hospital
Fuzhou, Fujian, 350014, China
Zhangzhou municipal hospital of fujian province
Zhangzhou, Fujian, 363099, China
Gansu provincial cancer hospital
Lanzhou, Gansu, 730050, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Affiliated cancer hospital and institute of guangzhou medical university
Guangzhou, Guangdong, 510095, China
Nanfang hospital
Guangzhou, Guangdong, 510515, China
Cancer hospital Chinses academy of medical sciences， shenzhen center
Shenzhen, Guangdong, 518172, China
Hainan cancer hospital
Haikou, Hainan, 570312, China
Affiliated hospital of Hebei university
Baoding, Hebei, 050031, China
The second people's hospital of Hengshui
Hengshui, Hebei, 053099, China
The Second Hospital of HeBei Medical University
Shijiazhuang, Hebei, 050004, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Tangshang people's hospital
Tangshan, Hebei, 063001, China
Harbin medical university cancer hospital
Harbin, Heilongjiang, 150081, China
Jiamusi Tuberculosis Prevention and Control Hospital (Jiamusi Cancer Hospital)
Jiamusi, Heilongjiang, 154007, China
The first hospital of Qiqihar
Qiqihar, Heilongjiang, 161005, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 450052, China
Nanyang central hospital
Nanyang, Henan, 473005, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, 45310, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410012, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The affiliated hospital of xuzhou medical university
Xuzhou, Jiangsu, 221799, China
First Affiliated Hospital of Gannan medical college
Ganzhou, Jiangxi, 341000, China
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The first hospital of Jilin Universit
Changchun, Jilin, 130061, China
Tonghua Central Hospital
Tonghua, Jilin, 134099, China
The First Hospital of China medical University
Shenyang, Liaoning, 110002, China
Liaoning cancer hospital
Shenyang, Liaoning, 110801, China
General hospital of ningxia medical university
Yinchuan, Ningxia, 750003, China
Qinghai university affiliated hospital
Xining, Qinghai, 810012, China
Binzhou medical university hospital
Binzhou, Shandong, 256603, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Weifang NO.2 people's Hospital
Weifang, Shandong, 261041, China
Zhongshan Hospital, Fudan university
Shanghai, Shanghai Municipality, 200032, China
Changzhi people's hospital
Changzhi, Shanxi, 046099, China
Shanxi Cancer hospital
Taiyuan, Shanxi, 030013, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610042, China
Mianyang central hospital
Mianyang, Sichuan, 621099, China
The Second People's Hospital of Yibin City
Yibin, Sichuan, 644000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222, China
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital /the Third Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650118, China
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Wang, M.D.
Cancer hospital, Chinese academy of medical sciences and Peking union medical college
- PRINCIPAL INVESTIGATOR
Qingming Wang
Henan Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2023
First Posted
August 14, 2023
Study Start
November 14, 2023
Primary Completion
August 5, 2025
Study Completion (Estimated)
November 28, 2026
Last Updated
August 14, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share