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: Ociperlimab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Tislelizumab; Drug: Cisplatin; Drug: Alcestobart

Study type: Interventional

Funder types: Industry

Identifiers

NCT05577702

CTR20222760 (Other Identifier)

BGB-LC-202

Details and patient eligibility

About

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.

Full 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.

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 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 5 patient groups

Arm 1A: Tislelizumab Monotherapy

Experimental group

Description:

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.

Treatment:

Drug: Tislelizumab

Arm 1B: Tislelizumab + Ociperlimab

Experimental group

Description:

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.

Treatment:

Drug: Tislelizumab

Drug: Ociperlimab

Arm 1C: Alcestobart + Tislelizumab

Experimental group

Description:

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.

Treatment:

Drug: Alcestobart

Drug: Tislelizumab

Arm 2A: Tislelizumab and Chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Pemetrexed

Drug: Tislelizumab

Drug: Paclitaxel

Drug: Carboplatin

Arm 2C: Alcestobart + Tislelizumab + Chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: Alcestobart

Drug: Cisplatin

Drug: Pemetrexed

Drug: Tislelizumab

Drug: Paclitaxel

Drug: Carboplatin