Trial Title:
A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer
NCT ID:
NCT05990127
Condition:
Locally Advanced or Metastatic NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Pemetrexed
Tislelizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
AK104
Description:
AK104 IV, q3w
Arm group label:
AK104 arm
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab IV, q3w
Arm group label:
Tislelizumab arm
Intervention type:
Drug
Intervention name:
carboplatin
Description:
carboplatin IV, q3w
Arm group label:
AK104 arm
Arm group label:
Tislelizumab arm
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed IV, q3w (for Nonsquamous NSCLC)
Arm group label:
AK104 arm
Arm group label:
Tislelizumab arm
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel IV, q3w (for squamous NSCLC)
Arm group label:
AK104 arm
Arm group label:
Tislelizumab arm
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%.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The first affiliated hospital of bengbu medical college
Address:
City:
Bengbu
Zip:
233099
Country:
China
Facility:
Name:
Anhui provincial hospital
Address:
City:
Hefei
Zip:
230001
Country:
China
Facility:
Name:
Anhui provincial cancer hospital
Address:
City:
Hefei
Zip:
230088
Country:
China
Facility:
Name:
The first affiliated hospital of wannan medical college
Address:
City:
Wuhu
Zip:
241001
Country:
China
Facility:
Name:
Cancer hospital, Chinese academy of medical sciences and Peking union medical college
Address:
City:
Beijing
Zip:
100021
Country:
China
Facility:
Name:
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Address:
City:
Beijing
Zip:
100039
Country:
China
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Facility:
Name:
Beijing Chest hospital
Address:
City:
Beijing
Zip:
101149
Country:
China
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Facility:
Name:
Fujian cancer hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Facility:
Name:
Zhangzhou municipal hospital of fujian province
Address:
City:
Zhangzhou
Zip:
363099
Country:
China
Facility:
Name:
Gansu provincial cancer hospital
Address:
City:
Lanzhou
Zip:
730050
Country:
China
Facility:
Name:
The First Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Facility:
Name:
Affiliated cancer hospital and institute of guangzhou medical university
Address:
City:
Guangzhou
Zip:
510095
Country:
China
Facility:
Name:
Nanfang hospital
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Facility:
Name:
Cancer hospital Chinses academy of medical sciences， shenzhen center
Address:
City:
Shenzhen
Zip:
518172
Country:
China
Facility:
Name:
Hainan cancer hospital
Address:
City:
Haikou
Zip:
570312
Country:
China
Facility:
Name:
Affiliated hospital of Hebei university
Address:
City:
Baoding
Zip:
050031
Country:
China
Facility:
Name:
The second people's hospital of Hengshui
Address:
City:
Hengshui
Zip:
053099
Country:
China
Facility:
Name:
The Second Hospital of HeBei Medical University
Address:
City:
Shijiazhuang
Zip:
050004
Country:
China
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Facility:
Name:
Tangshang people's hospital
Address:
City:
Tangshan
Zip:
063001
Country:
China
Facility:
Name:
Harbin medical university cancer hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Facility:
Name:
Jiamusi Tuberculosis Prevention and Control Hospital (Jiamusi Cancer Hospital)
Address:
City:
Jiamusi
Zip:
154007
Country:
China
Facility:
Name:
The first hospital of Qiqihar
Address:
City:
Qiqihar
Zip:
161005
Country:
China
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
450052
Country:
China
Facility:
Name:
Nanyang central hospital
Address:
City:
Nanyang
Zip:
473005
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xinxiang Medical College
Address:
City:
Xinxiang
Zip:
45310
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Facility:
Name:
Renmin Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430060
Country:
China
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Facility:
Name:
Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410008
Country:
China
Facility:
Name:
The Second Xiangya Hospital, Central South University
Address:
City:
Changsha
Zip:
410012
Country:
China
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Facility:
Name:
The affiliated hospital of xuzhou medical university
Address:
City:
Xuzhou
Zip:
221799
Country:
China
Facility:
Name:
First Affiliated Hospital of Gannan medical college
Address:
City:
Ganzhou
Zip:
341000
Country:
China
Facility:
Name:
First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Facility:
Name:
The first hospital of Jilin Universit
Address:
City:
Changchun
Zip:
130061
Country:
China
Facility:
Name:
Tonghua Central Hospital
Address:
City:
Tonghua
Zip:
134099
Country:
China
Facility:
Name:
The First Hospital of China medical University
Address:
City:
Shenyang
Zip:
110002
Country:
China
Facility:
Name:
Liaoning cancer hospital
Address:
City:
Shenyang
Zip:
110801
Country:
China
Facility:
Name:
General hospital of ningxia medical university
Address:
City:
Yinchuan
Zip:
750003
Country:
China
Facility:
Name:
Qinghai university affiliated hospital
Address:
City:
Xining
Zip:
810012
Country:
China
Facility:
Name:
Binzhou medical university hospital
Address:
City:
Binzhou
Zip:
256603
Country:
China
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Zip:
266000
Country:
China
Facility:
Name:
Weifang NO.2 people's Hospital
Address:
City:
Weifang
Zip:
261041
Country:
China
Facility:
Name:
Zhongshan Hospital, Fudan university
Address:
City:
Shanghai
Zip:
200032
Country:
China
Facility:
Name:
Changzhi people's hospital
Address:
City:
Changzhi
Zip:
046099
Country:
China
Facility:
Name:
Shanxi Cancer hospital
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Zip:
610042
Country:
China
Facility:
Name:
Mianyang central hospital
Address:
City:
Mianyang
Zip:
621099
Country:
China
Facility:
Name:
The Second People's Hospital of Yibin City
Address:
City:
Yibin
Zip:
644000
Country:
China
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Facility:
Name:
Tianjin Chest Hospital
Address:
City:
Tianjin
Zip:
300222
Country:
China
Facility:
Name:
Xinjiang Medical University Cancer Hospital
Address:
City:
Urumqi
Zip:
830000
Country:
China
Facility:
Name:
Yunnan Cancer Hospital /the Third Affiliated Hospital of Kunming Medical University
Address:
City:
Kunming
Zip:
650118
Country:
China
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Start date:
November 14, 2023
Completion date:
November 28, 2026
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05990127
