A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer

BeiGene

Status and phase: Active, not recruiting; Phase 2

Conditions: Metastatic Non-small Cell Lung Cancer; Non-small Cell Lung Cancer

Treatments: Drug: pemetrexed; Drug: LBL-007; Drug: Tislelizumab; Drug: Cisplatin; Drug: BGB-15025; Drug: BGB-A445; Drug: Carboplatin; Drug: Nab paclitaxel; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05635708

CTR20230892 (Other Identifier)

2022-502738-18-00 (EU Trial (CTIS) Number)

BGB-LC-201

Details and patient eligibility

About

The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (< 50%).

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.
2. No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment.
3. Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study.
4. At least 1 measurable lesion as defined per RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion criteria

1. Has mixed small cell lung cancer.
2. Participants with known actionable mutations (including but not limited to EGFR, ALK, BRAF, RET, and ROSI mutations) for which a targeted therapy is available per local standard of care.
3. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any other antibody or drug targeting T-cell costimulation or immune checkpoint pathways. Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy prior to radiologic recurrence of disease.
4. Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment.
5. Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases.

NOTE: Other protocol and sub-study protocol defined criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 8 patient groups

Sub-study 1: Experimental Arm 1A

Experimental group

Description:

Tislelizumab + BGB-A445

Treatment:

Drug: BGB-A445

Drug: Tislelizumab

Sub-study 1: Experimental Arm 2A

Experimental group

Description:

Tislelizumab + LBL-007

Treatment:

Drug: LBL-007

Drug: Tislelizumab

Sub-study 1: Experimental Arm 3A

Experimental group

Description:

Tislelizumab + BGB-15025

Treatment:

Drug: BGB-15025

Drug: Tislelizumab

Sub-study 1: Reference Arm Tislelizumab alone

Experimental group

Description:

Tislelizumab alone

Treatment:

Drug: Tislelizumab

Sub-study 2: Experimental Arm 1B

Experimental group

Description:

Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445

Treatment:

Drug: Paclitaxel

Drug: Nab paclitaxel

Drug: Carboplatin

Drug: BGB-A445

Drug: Cisplatin

Drug: pemetrexed

Drug: Tislelizumab

Sub-study 2: Experimental Arm 2B

Experimental group

Description:

Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007

Treatment:

Drug: Paclitaxel

Drug: Nab paclitaxel

Drug: Carboplatin

Drug: Cisplatin

Drug: pemetrexed

Drug: LBL-007

Drug: Tislelizumab

Sub-study 2: Experimental Arm 3B

Experimental group

Description:

Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025

Treatment:

Drug: Paclitaxel

Drug: Nab paclitaxel

Drug: Carboplatin

Drug: BGB-15025

Drug: Cisplatin

Drug: pemetrexed

Drug: Tislelizumab

Sub-study 2: Reference Arm

Active Comparator group

Description:

Tislelizumab + investigator's choice of histology-appropriate chemotherapy

Treatment:

Drug: Paclitaxel

Drug: Nab paclitaxel

Drug: Carboplatin

Drug: Cisplatin

Drug: pemetrexed

Drug: Tislelizumab