WCLC 2025 - Posters & ePosters-P2.08 .29 Phase 2 Trial of Tislelizumab Plus Chemotherapy Induction Therapy for Newly Diagnosed Stage III Unresectable NSCLC

P2.08 .29 Phase 2 Trial of Tislelizumab Plus Chemotherapy Induction Therapy for Newly Diagnosed Stage III Unresectable NSCLC

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Pdf Summary

This Phase 2 open-label, single-arm prospective trial evaluated the efficacy and safety of Tislelizumab combined with chemotherapy as induction therapy in 19 patients with newly diagnosed unresectable stage III non-small cell lung cancer (NSCLC) without EGFR mutations or ALK fusion. Patients received 2-4 cycles of Tislelizumab plus platinum-based chemotherapy, followed by surgery and adjuvant Tislelizumab for up to one year. <br /><br />Among 12 patients completing induction, 10 (83.3%) were successfully converted to surgical candidates and all underwent complete (R0) resection via fully robotic thoracoscopic surgery. Pathological downstaging was achieved in 90%, with major pathological response (MPR) in 50% and pathologic complete response (pCR) in 40%. The objective response rate (ORR) was 66.7%, with 66.7% partial responses and 25% stable disease. Surgeries predominantly involved lobectomy (70%) or sleeve lobectomy (30%), with a median operation time of 112.5 minutes and minimal blood loss. <br /><br />Treatment-related adverse events (TRAEs) of grade 3 severity occurred in 16.7%, primarily leukopenia and neutropenia. Immune-related adverse events (irAEs) occurred in 33.3%, including rash (25%), hyperthyroidism (8.3%), and hypothyroidism (8.3%). Common lower-grade TRAEs included alopecia, decreased appetite, nausea, limb weakness, rash, and peripheral neuropathy. <br /><br />These findings suggest that Tislelizumab plus chemotherapy induction therapy demonstrates promising antitumor activity with manageable toxicity in unresectable stage III NSCLC, achieving high surgical conversion and R0 resection rates. This approach may enable sequential surgery in patients traditionally considered inoperable, but further studies are needed to confirm long-term survival benefits.

Asset Subtitle

Zhe Wu

Meta Tag

Speaker Zhe Wu

Topic Local-Regional Non-small Cell Lung Cancer

Keywords

Tislelizumab

chemotherapy

induction therapy

stage III non-small cell lung cancer

NSCLC

unresectable

surgical conversion

major pathological response

pathologic complete response

treatment-related adverse events