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

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene

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)

• Participant must have tumor PD-L1 expression ≥ 1% determined by a local laboratory with an approved assay

• Tumor PD-L1 expression ≥ 50% for participants enrolled for Arm A, Arm B, and Arm C in Stage 1

• 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 containing approximately one core needle of biopsy sample of the primary tumor for biomarker evaluation during screening to the central laboratory

Exclusion Criteria:

• Any prior antineoplastic therapy(ies) for current lung cancer (eg, radiotherapy, targeted therapies, ablation, or other systemic or local antineoplastic treatment)

• Participants with large cell neuroendocrine carcinoma (LCNEC)

• The presence of locally advanced unresectable NSCLC regardless of stage or metastatic disease (Stage IV). Mediastinal lymph node samples are required for clinical staging to assess nodal involvement in participants with contralateral mediastinal adenopathy on CT scan

• History of interstitial lung disease, pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases

• Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection

• Known actionable mutations (including but not limited to EGFR, ALK, BRAF, RET, and ROS1 mutations)

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