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A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations With and Without Chemotherapy as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to IIIA Non-Small Cell Lung Cancer
This study was conducted to evaluate the preliminary effectiveness and safety of treatment with tislelizumab alone and in combination with other investigational agents prior to surgery (neoadjuvant treatment) in adults with non-small cell lung cancer (NSCLC) that is able to be removed by surgery.
This is a randomized, open-label, multicenter, Phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in Chinese participants with resectable Stage II to IIIA NSCLC. The study is designed with the flexibility of adding treatment arms as new treatments become available or discontinuing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and of modifying the participant population. The study consisted of a neoadjuvant treatment phase (2 - 4 cycles of treatment), a surgery phase and a follow-up phase.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Guangzhou Medical Universitydatansha Hospital)
Guangzhou, Guangdong, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
Anyang Cancer Hospital
Anyang, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Start Date
March 8, 2023
Primary Completion Date
December 13, 2024
Completion Date
January 23, 2025
Last Updated
February 9, 2026
121
ACTUAL participants
Tislelizumab
DRUG
Ociperlimab
DRUG
Alcestobart
DRUG
Cisplatin
DRUG
Carboplatin
DRUG
Pemetrexed
DRUG
Paclitaxel
DRUG
Lead Sponsor
BeiGene
NCT07485114
NCT06066138
Data Source & Attribution
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