A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer
NCT ID: NCT05990127
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE3
642 participants
INTERVENTIONAL
2023-11-14
2026-11-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
NCT05840016
A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer
NCT03866993
Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer
NCT05900921
A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT04647344
Phase 3 Clinical Study of AK112 for NSCLC Patients
NCT05184712
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AK104 arm
AK104
AK104 IV, q3w
carboplatin
carboplatin IV, q3w
Pemetrexed
Pemetrexed IV, q3w (for Nonsquamous NSCLC)
Paclitaxel
Paclitaxel IV, q3w (for squamous NSCLC)
Tislelizumab arm
Tislelizumab
Tislelizumab IV, q3w
carboplatin
carboplatin IV, q3w
Pemetrexed
Pemetrexed IV, q3w (for Nonsquamous NSCLC)
Paclitaxel
Paclitaxel IV, q3w (for squamous NSCLC)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Aged ≥18 years when the subject signed the informed consent.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 3 months.
5. 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).
6. No prior systemic therapy for advanced or metastatic NSCLC was received.
7. PD-L1 TPS \< 1%.
8. No EGFR sensitive mutations or ALK gene translocation alterations.
Exclusion Criteria
2. NSCLC with driver gene mutations for approved targeted drug indications.
3. Active central nervous system (CNS) metastases were present.
4. Pulmonary radiation therapy \> 30 Gy within 6 months prior to first dose.
5. Active malignant tumors within the past 5 years, except for tumors in this study and scured local tumors.
6. Pregnant or lactating women.
7. Clinically significant cardiovascular or cerebrovascular disease.
8. 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.
9. 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.
10. Known active pulmonary tuberculosis.
11. Patients with active hepatitis B or active hepatitis C.
12. Known medical history of immunodeficiency or positive HIV test.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Akeso
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jie Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cancer hospital, Chinese academy of medical sciences and Peking union medical college
Qingming Wang
Role: PRINCIPAL_INVESTIGATOR
Henan Cancer Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AK104-307
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.