A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer
Non-Small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
Key Inclusion Criteria:
- Age 18-75 years old, male or female, signed informed consent form (ICF).
- Advanced NSCLC diagnosed by pathological or clinical physicians
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
- Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1
- Must be treatment-naive for locally advanced or metastatic squamous NSCLC.
- Life expectancy ≥ 12 weeks
- Participants must have adequate organ function
- Male/Female is willing to use a highly effective method of birth control
Key Exclusion Criteria:
- Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing mutation or ALK gene translocation
- Received any approved systemic anticancer therapy
- Received prior treatment with EGFR inhibitors or ALK inhibitors
- Received prior therapies targeting PD-1 or PD-L1
- With history of interstitial lung disease
- Clinically significant pericardial effusion
- Sever infections, Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Any major surgical procedure before randomization
- HIV infection
- Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (HCV)
- Active autoimmune diseases or history of autoimmune diseases
- History of allergic reactions to chemotherapy
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Anhui Provincial Hospital
- The First Affiliated Hospital of Anhui Medical University
- Cancer Hospital Chinese Academy of Medical Sciences
- Beijing Cancer Hospital
- Beijing Hospital
- Peking Union Medical College Hospital
- Chinese PLA General Hospital
- Beijing Chest Hospital,Capital Medical University
- The Second Affiliated Hospital of Chongqing Medical University
- The First Hospital Affiliated to AMU (Southwest Hospital)
- Daping Hospital of The 3rd Military University
- Chongqing Sanxia Central Hospital
- Fujian Tumor Hospital
- The First Affiliated Hospital of Xiamen University
- Nanfang Hospital of Southern Medical University
- Cancer Center of Guangzhou Medical University
- Cancer Hospital of Shantou University Medical College
- The People's Hospital of Guangxi Zhuang Autonomous Region
- Affiliated Hospital of Zunyi Medical College
- Harbin Medical University Cancer Hospital
- Henan Cancer Hospital
- The First Affiliated Hospital, Zhengzhou University
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
- Hubei Cancer Hospital
- 2nd Hospital of Central South University
- Hunan Cancer Hospital
- Nanjing General Hospital
- Jiangsu Province Hospital
- The First Affiliated Hospital of Soochow University
- Xuzhou Central Hospital
- The First Hospital of Jilin University
- Liaoning Cancer Hospital & Institute
- Jinan Central Hospital
- The 96th Hospital of the Joint Service Support Force of the People's Liberation Army of China
- Shandong Cancer Hospital
- Qilu Hospital of Shandong University
- Weifang People's Hospital
- Shanghai Chest Hospital
- The First Affiliated Hospital of Xi'an Jiaotong University
- West China Hospital, Sichuan University
- Tianjin Medical University General Hospital
- Tianjin Medical University Cancer Institute & Hospital
- Hangzhou First People's Hospital
- The First Affiliated Hospital, Zhejiang University
- Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Tislelizumab + Paclitaxel + Carboplatin
Tislelizumab + Nab-paclitaxel + Carboplatin
Paclitaxel + Carboplatin
Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
Paclitaxel 175 mg/m^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)