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Starting soon Phase 3

A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer

NCT05990127 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Phase 3
Started
2023-11-14
Last updated
2023-08-14

Condition(s) studied

Locally Advanced or Metastatic NSCLC

Investigational drug(s) / intervention(s)

AK104 →Tislelizumab →carboplatin →Pemetrexed →Paclitaxel →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

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)

FacilityCityRegionStatus
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.

Official registry record

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