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

NCT ID: NCT05577702

Last Updated: 2026-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2025-01-23

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1A: Tislelizumab Monotherapy

Participants with tumor programmed death protein ligand-1 (PD-L1) expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Administered as an intravenous infusion once every 3 weeks

Arm 1B: Tislelizumab + Ociperlimab

Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Administered as an intravenous infusion once every 3 weeks

Ociperlimab

Intervention Type: DRUG

Administered as an intravenous infusion once every 3 weeks

Arm 1C: Alcestobart + Tislelizumab

Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Administered as an intravenous infusion once every 3 weeks

Alcestobart

Intervention Type: DRUG

Administered as an intravenous infusion once every 3 weeks

Arm 2A: Tislelizumab and Chemotherapy

Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Administered as an intravenous infusion once every 3 weeks

Cisplatin

Intervention Type: DRUG

75 mg/m\^2 administered as an intravenous infusion once every 3 weeks

Carboplatin

Intervention Type: DRUG

Administered as an intravenous infusion once every 3 weeks at an area under the curve (AUC) of 5 mg/mL/min

Pemetrexed

Intervention Type: DRUG

500 mg/m\^2 administered as an intravenous infusion once every 3 weeks in participants with non-squamous NSCLC

Paclitaxel

Intervention Type: DRUG

175 mg/m\^2 administered as an intravenous infusion once every 3 weeks in participants with squamous NSCLC

Arm 2C: Alcestobart + Tislelizumab + Chemotherapy

Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Administered as an intravenous infusion once every 3 weeks

Alcestobart

Intervention Type: DRUG

Administered as an intravenous infusion once every 3 weeks

Cisplatin

Intervention Type: DRUG

75 mg/m\^2 administered as an intravenous infusion once every 3 weeks

Carboplatin

Intervention Type: DRUG

Administered as an intravenous infusion once every 3 weeks at an area under the curve (AUC) of 5 mg/mL/min

Pemetrexed

Intervention Type: DRUG

500 mg/m\^2 administered as an intravenous infusion once every 3 weeks in participants with non-squamous NSCLC

Paclitaxel

Intervention Type: DRUG

175 mg/m\^2 administered as an intravenous infusion once every 3 weeks in participants with squamous NSCLC

Interventions

Tislelizumab

Administered as an intravenous infusion once every 3 weeks

Intervention Type: DRUG

Ociperlimab

Administered as an intravenous infusion once every 3 weeks

Intervention Type: DRUG

Alcestobart

Administered as an intravenous infusion once every 3 weeks

Intervention Type: DRUG

Cisplatin

75 mg/m\^2 administered as an intravenous infusion once every 3 weeks

Intervention Type: DRUG

Carboplatin

Administered as an intravenous infusion once every 3 weeks at an area under the curve (AUC) of 5 mg/mL/min

Intervention Type: DRUG

Pemetrexed

500 mg/m\^2 administered as an intravenous infusion once every 3 weeks in participants with non-squamous NSCLC

Intervention Type: DRUG

Paclitaxel

175 mg/m\^2 administered as an intravenous infusion once every 3 weeks in participants with squamous NSCLC

Intervention Type: DRUG

Other Intervention Names

BGB-A317; Tevimbra; BGB-A1217; LBL-007

Eligibility Criteria

Inclusion Criteria

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• Histologically confirmed Stage II-IIIA NSCLC (per the Eighth American Joint Committee on Cancer/Union Internationale Contre le Cancer [NSCLC] staging system)
• Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
• Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained ≤ 7 days before randomization
• Provide formalin-fixed paraffin-embedded block (preferred) or at least 15 freshly cut unstained FFPE slides of the primary tumor for biomarker evaluation during screening

Exclusion Criteria

• Any prior antineoplastic therapy(ies) for current lung cancer (eg, radiotherapy, targeted therapies, ablation, or other systemic or local antineoplastic treatment)
• Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-cell immunoglobulin and ITIM domain (TIGIT), anti-lymphocyte activation gene-3 (LAG-3), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• Has mixed small cell lung cancer
• Participants with large cell neuroendocrine carcinoma (LCNEC)
• The presence of locally advanced unresectable NSCLC regardless of stage or metastatic disease
• Known epidermal growth factor receptor (EGFR) sensitizing mutations and/or anaplastic lymphoma kinase (ALK) rearrangement

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

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

Shandong Cancer Hospital

Jinan, Shandong, China

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)

Ningbo, Zhejiang, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CTR20222760

Identifier Type: OTHER

Identifier Source: secondary_id

BGB-LC-202

Identifier Type: -

Identifier Source: org_study_id