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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05990127
Other study ID # AK104-307
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date November 14, 2023
Est. completion date November 28, 2026

Study information

Verified date August 2023
Source Akeso
Contact Zhifang Yao, M.D.
Phone +86-0760-89873999
Email clinicaltrials@akesobio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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%.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 642
Est. completion date November 28, 2026
Est. primary completion date August 5, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. The subjects voluntarily participated in the study with full informed consent and signed written informed consent form. 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: 1. Histologically confirmed small cell lung cancer (SCLC). 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Country Name City State
China Affiliated hospital of Hebei university Baoding Hebei
China Beijing Cancer Hospital Beijing Beijing
China Beijing Chest hospital Beijing Beijing
China Cancer hospital, Chinese academy of medical sciences and Peking union medical college Beijing Beijing
China The Fifth Medical Center of the Chinese People's Liberation Army General Hospital Beijing Beijing
China The first affiliated hospital of bengbu medical college Bengbu Anhui
China Binzhou medical university hospital Binzhou Shandong
China The first hospital of Jilin Universit Changchun Jilin
China Hunan Cancer Hospital Changsha Hunan
China The Second Xiangya Hospital, Central South University Changsha Hunan
China Xiangya Hospital of Central South University Changsha Hunan
China Changzhi people's hospital Changzhi Shanxi
China Sichuan Cancer Hospital Chengdu Sichuan
China Chongqing University Cancer Hospital Chongqing Chongqing
China Fujian cancer hospital Fuzhou Fujian
China First Affiliated Hospital of Gannan medical college Ganzhou Jiangxi
China Affiliated cancer hospital and institute of guangzhou medical university Guangzhou Guangdong
China Nanfang hospital Guangzhou Guangdong
China The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
China Hainan cancer hospital Haikou Hainan
China The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) Hangzhou Zhejiang
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Harbin medical university cancer hospital Harbin Heilongjiang
China Anhui provincial cancer hospital Hefei Anhui
China Anhui provincial hospital Hefei Anhui
China The second people's hospital of Hengshui Hengshui Hebei
China Jiamusi Tuberculosis Prevention and Control Hospital (Jiamusi Cancer Hospital) Jiamusi Heilongjiang
China Shandong Cancer Hospital Jinan Shandong
China Yunnan Cancer Hospital /the Third Affiliated Hospital of Kunming Medical University Kunming Yunnan
China Gansu provincial cancer hospital Lanzhou Gansu
China The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
China Mianyang central hospital Mianyang Sichuan
China First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Nanyang central hospital Nanyang Henan
China The Affiliated Hospital of Qingdao University Qingdao Shandong
China The first hospital of Qiqihar Qiqihar Heilongjiang
China Zhongshan Hospital, Fudan university Shanghai Shanghai
China Liaoning cancer hospital Shenyang Liaoning
China The First Hospital of China medical University Shenyang Liaoning
China Cancer hospital Chinses academy of medical sciences, shenzhen center Shenzhen Guangdong
China The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei
China The Second Hospital of HeBei Medical University Shijiazhuang Hebei
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu
China Shanxi Cancer hospital Taiyuan Shanxi
China Tangshang people's hospital Tangshan Hebei
China Tianjin Chest Hospital Tianjin Tianjin
China Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin
China Tonghua Central Hospital Tonghua Jilin
China Xinjiang Medical University Cancer Hospital Urumqi Xinjiang
China Weifang NO.2 people's Hospital Weifang Shandong
China Hubei Cancer Hospital Wuhan Hubei
China Renmin Hospital of Wuhan University Wuhan Hubei
China The first affiliated hospital of wannan medical college Wuhu Anhui
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China Qinghai university affiliated hospital Xining Qinghai
China The First Affiliated Hospital of Xinxiang Medical College Xinxiang Henan
China The affiliated hospital of xuzhou medical university Xuzhou Jiangsu
China The Second People's Hospital of Yibin City Yibin Sichuan
China General hospital of ningxia medical university Yinchuan Ningxia
China Zhangzhou municipal hospital of fujian province Zhangzhou Fujian
China Henan Cancer Hospital Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 Progression-Free Survival(PFS) by Blind independent center review(BIRC) 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 Objective response rate (ORR) was assessed by INV ORR is the proportion of subjects with CR or PR based on RECIST v1.1 Through Database Cutoff Date (Up to approximately 39 months)
Secondary Disease control rate (DCR) was assessed by INV Disease control rate (DCR) was assessed based on RECIST V1.1 criteria Through Database Cutoff Date (Up to approximately 39 months)
Secondary Time to response (TTR) was assessed by INV The time from the first administration to the date of documented CR or PR Through Database Cutoff Date (Up to approximately 39 months)
Secondary Duration of response (DOR) was assessed by INV Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria Through Database Cutoff Date (Up to approximately 39 months)
Secondary Objective response rate (ORR) was assessed by BIRC ORR is the proportion of subjects with CR or PR based on RECIST v1.1 Through Database Cutoff Date (Up to approximately 39 months)
Secondary Disease control rate (DCR) was assessed BIRC Disease control rate (DCR) was assessed based on RECIST V1.1 criteria Through Database Cutoff Date (Up to approximately 39 months)
Secondary Time to response (TTR) was assessed by BIRC The time from the first administration to the date of documented CR or PR Through Database Cutoff Date (Up to approximately 39 months)
Secondary Duration of response (DOR) was assessed by BIRC Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria Through Database Cutoff Date (Up to approximately 39 months)
Secondary The number of subjects experiencing adverse events (AEs) Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results. Through Database Cutoff Date (Up to approximately 39 months)
Secondary Pharmacokinetic The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration Through Database Cutoff Date (Up to approximately 39 months)
Secondary Antidrug antibodies (ADA) of AK104 Proportion of subjects who develop detectable anti-drug antibodies (ADAs) Through Database Cutoff Date (Up to approximately 39 months)
Secondary Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) EORTC QLQ-C30 measures cancer patients' physical, psychological, and social functions. Scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". Higher score for the functioning scales and global health status denotes a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms. Through Database Cutoff Date (Up to approximately 39 months)
Secondary Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 module (EORTC QLQ-LC29) EORTC-QLQ-LC29 measures the quality of life in patients with lung cancer. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". For symptoms scales, higher scores indicated greater symptom burden. Through Database Cutoff Date (Up to approximately 39 months)
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