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
2 other identifiers
interventional
121
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2023
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2022
CompletedFirst Posted
Study publicly available on registry
October 13, 2022
CompletedStudy Start
First participant enrolled
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2025
CompletedResults Posted
Study results publicly available
February 9, 2026
CompletedFebruary 9, 2026
January 1, 2026
1.8 years
October 10, 2022
January 16, 2026
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Major Pathological Response (MPR) Rate
Tumor tissue and lymph node tissue obtained from surgical resection were sent to a central laboratory according to study pathology manuals for pathological response analysis. MPR rate is defined as the percentage of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR). Participants without surgery or pathological results were considered non-responders.
At the time of surgery, approximately Week 16
Secondary Outcomes (10)
Pathological Complete Response (pCR)
At the time of surgery, approximately Week 16
Event-free Survival (EFS)
From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.
Event-free Survival Rate
12 months and 24 months after randomization
Overall Survival (OS)
From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.
Overall Survival Rate
12 months and 24 months after randomization
- +5 more secondary outcomes
Study Arms (5)
Arm 1A: Tislelizumab Monotherapy
EXPERIMENTALParticipants 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.
Arm 1B: Tislelizumab + Ociperlimab
EXPERIMENTALParticipants 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.
Arm 1C: Alcestobart + Tislelizumab
EXPERIMENTALParticipants 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.
Arm 2A: Tislelizumab and Chemotherapy
EXPERIMENTALParticipants 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.
Arm 2C: Alcestobart + Tislelizumab + Chemotherapy
EXPERIMENTALParticipants 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.
Interventions
Administered as an intravenous infusion once every 3 weeks
Administered as an intravenous infusion once every 3 weeks
Administered as an intravenous infusion once every 3 weeks
75 mg/m\^2 administered as an intravenous infusion once every 3 weeks
Administered as an intravenous infusion once every 3 weeks at an area under the curve (AUC) of 5 mg/mL/min
500 mg/m\^2 administered as an intravenous infusion once every 3 weeks in participants with non-squamous NSCLC
175 mg/m\^2 administered as an intravenous infusion once every 3 weeks in participants with squamous NSCLC
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (14)
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Guangzhou Medical Universitydatansha Hospital)
Guangzhou, Guangdong, 510140, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021, China
Anyang Cancer Hospital
Anyang, Henan, 455001, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, 332000, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
Ningbo, Zhejiang, 315000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2022
First Posted
October 13, 2022
Study Start
March 8, 2023
Primary Completion
December 13, 2024
Study Completion
January 23, 2025
Last Updated
February 9, 2026
Results First Posted
February 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
Begene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. Beigene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for Beigene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.