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

BeiGene

Status and phase

Completed

Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Cisplatin

Drug: Tislelizumab

Drug: Pemetrexed

Drug: Ociperlimab

Drug: Paclitaxel

Drug: Carboplatin

Drug: LBL-007

Study type

Interventional

Funder types

Industry

Identifiers

NCT05577702

CTR20222760 (Other Identifier)

BGB-LC-202

Details and patient eligibility

About

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 non-small cell lung cancer (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.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 costimulation 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 EGFR sensitizing mutations and/or ALK rearrangement

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

121 participants in 5 patient groups

Arm 1A: Tislelizumab Monotherapy

Experimental group

Description:

Tislelizumab on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days)

Treatment:

Drug: Tislelizumab

Arm 1B: Tislelizumab and Ociperlimab

Experimental group

Description:

Tislelizumab + ociperlimab on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days)

Treatment:

Drug: Ociperlimab

Drug: Tislelizumab

Arm 1C: Tislelizumab and LBL-007

Experimental group

Description:

Tislelizumab + LBL-007 on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days)

Treatment:

Drug: LBL-007

Drug: Tislelizumab

Arm 2A: Tislelizumab and Chemotherapy

Experimental group

Description:

Tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous)

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Drug: Pemetrexed

Drug: Cisplatin

Drug: Tislelizumab

Arm 2C: LBL-007 and Tislelizumab and Chemotherapy

Experimental group

Description:

LBL-007 + tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include: * Cisplatin/carboplatin + pemetrexed (nonsquamous) * Cisplatin/carboplatin + paclitaxel (squamous)

Treatment:

Drug: LBL-007

Drug: Carboplatin

Drug: Paclitaxel

Drug: Pemetrexed

Drug: Cisplatin

Drug: Tislelizumab