WCLC 2025 - Posters & ePosters-P3.18.07 Immunotherapy Combined With Radiotherapy as Neoadjuvant Therapy in Resectable NSCLC: A Single Arm, Phase II Clinical Study

P3.18.07 Immunotherapy Combined With Radiotherapy as Neoadjuvant Therapy in Resectable NSCLC: A Single Arm, Phase II Clinical Study

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This single-arm, phase II clinical study investigates the efficacy and safety of neoadjuvant immunotherapy combined with radiotherapy in resectable stage IB–IIIA non-small cell lung cancer (NSCLC). Conducted at Northern Jiangsu People's Hospital, the trial enrolls approximately 20 patients aged 18–70 with previously untreated, histologically confirmed resectable NSCLC, an ECOG performance status of 0-1, and no sensitizing EGFR mutations or ALK rearrangements.<br /><br />The primary objective is to assess the pathological complete response (pCR) rate following neoadjuvant treatment with tislelizumab—a PD-1 inhibitor—combined with intensity-modulated thoracic radiotherapy (40 Gy over 20 fractions). Secondary objectives include measuring major pathological response (MPR), one-year event-free survival (EFS), safety, tolerability, surgical feasibility, and peri/postoperative complications.<br /><br />Treatment involves 3–4 cycles of tislelizumab every 3 weeks concurrently with radiotherapy targeting primary tumors and involved lymph nodes, followed by surgical resection within 3–6 weeks after neoadjuvant therapy. Post-surgery, adjuvant tislelizumab is administered for up to one year, with additional chemotherapy considered if postoperative minimal residual disease (MRD) tests are positive. Tumor response is evaluated using RECIST v1.1 criteria via imaging at baseline, after two neoadjuvant cycles, pre-surgery, and during follow-up up to 5 years or disease progression.<br /><br />This trial builds on prior evidence that neoadjuvant immunochemotherapy achieves pCR rates around 20–25%, and that tislelizumab combined with chemotherapy can improve pCR and MPR rates significantly (41% and 56%, respectively). The study aims to evaluate a chemo-free neoadjuvant regimen combining radiotherapy and immunotherapy, potentially offering a favorable pathological remission with manageable safety profiles. The results may inform optimal dosing, timing, and integration strategies for combined radio-immunotherapy in early-stage resectable NSCLC.

Asset Subtitle

Buhai Wang

Meta Tag

Speaker Buhai Wang

Topic Clinical Trials in Progress

Keywords

neoadjuvant immunotherapy

radiotherapy

non-small cell lung cancer

NSCLC

tislelizumab

pathological complete response

phase II clinical trial

resectable lung cancer

PD-1 inhibitor

intensity-modulated thoracic radiotherapy