NCT05577702

Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	Administered as an intravenous infusion once every 3 weeks
DRUG	Ociperlimab	Administered as an intravenous infusion once every 3 weeks
DRUG	Alcestobart	Administered as an intravenous infusion once every 3 weeks
DRUG	Cisplatin	75 mg/m\^2 administered as an intravenous infusion once every 3 weeks
DRUG	Carboplatin	Administered as an intravenous infusion once every 3 weeks at an area under the curve (AUC) of 5 mg/mL/min
DRUG	Pemetrexed	500 mg/m\^2 administered as an intravenous infusion once every 3 weeks in participants with non-squamous NSCLC
DRUG	Paclitaxel	175 mg/m\^2 administered as an intravenous infusion once every 3 weeks in participants with squamous NSCLC

Timeline

• Start date: 2023-03-08
• Primary completion: 2024-12-13
• Completion: 2025-01-23
• First posted: 2022-10-13
• Last updated: 2026-02-09
• Results posted: 2026-02-09

Locations

14 sites across 1 country: China