Phase 2
Completed N=121
Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer
Non Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT05577702 ↗
Enrolled (actual)
121
Serious AEs
16.8%
Results posted
Feb 2026
Primary outcomePrimary: Major Pathological Response (MPR) Rate — 45.0; 50.0; 40.0; 55.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Pathological Response (MPR) Rate |
45.0; 50.0; 40.0; 55.0; 34.1 | — |
| SECONDARY Pathological Complete Response (pCR) |
30.0; 30.0; 40.0; 35.0; 17.1 | — |
| SECONDARY Event-free Survival (EFS) |
NA; NA; 11.4; 11.6; NA | — |
| SECONDARY Event-free Survival Rate |
75.3; 60.0; 44.0; 0.0; 50.5; NA | — |
| SECONDARY Overall Survival (OS) |
NA; NA; NA; NA; NA | — |
| SECONDARY Overall Survival Rate |
91.7; 89.7; 90.0; 58.6; 94.9; NA | — |
| SECONDARY Disease-free Survival (DFS) |
NA; NA; NA; 8.7; NA | — |
| SECONDARY Disease-free Survival Rate |
75.0; 60.6; 50.0; 0.0; NA; NA | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
7; 14; 15; 19; 39; 0 | — |
| SECONDARY Feasibility of Surgery |
16; 14; 12; 17; 31; 4 | — |
| SECONDARY Duration of Surgery |
3.33; 3.50; 3.39; 4.30; 4.05 | — |
Eligibility 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)
- 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.
Data sourced from ClinicalTrials.gov (NCT05577702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.