WCLC 2025 - Posters & ePosters-P3.18.50 Induction Tislelizumab With Chemotherapy Followed by Surgery and Radiotherapy in Stage Ill-N3 Unresectable NSCLC (HURRICANE)

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This Phase II prospective, single-arm clinical trial (NCT06908733) in China evaluates a novel comprehensive treatment strategy for patients with unresectable, locally advanced stage III-N3 non-small cell lung cancer (NSCLC). The current standard care of chemoradiotherapy (CRT) followed by immunotherapy consolidation has limitations: up to 30% of patients are ineligible for immunotherapy, and intrathoracic local recurrence remains a major cause of treatment failure. Optimizing local control is crucial, especially for N3 lymph node involvement (stage IIIB-IIIC).<br /><br />The trial investigates induction therapy using tislelizumab (200mg IV every 3 weeks) combined with chemotherapy (3-4 cycles), followed by multidisciplinary evaluation for surgery feasibility. Patients deemed operable and willing undergo surgery targeting the primary tumor and ipsilateral hilar and mediastinal lymph nodes, followed by hypofractionated radiotherapy (54-66 Gy) with concurrent chemotherapy. Those inoperable or unwilling to receive surgery receive radiotherapy to N3 lymph nodes with concurrent chemotherapy. Subsequent immunotherapy consolidation with tislelizumab continues up to one year or until progression/toxicity.<br /><br />Key eligibility criteria include treatment-naive adults (≥18 years) with histologically confirmed NSCLC, clinical stage T1-4N3M0, ECOG 0-1, no sensitive mutation, and absence of infiltration into major structures (aorta, trachea, etc.). The study will enroll 30 patients across 6-7 centers, starting April 2025 with primary completion targeted for August 2027.<br /><br />Primary endpoint is 1-year event-free survival (EFS). Secondary endpoints include overall survival (OS), surgical conversion rate, time to distant metastases/local recurrence, adverse events, and patient-reported outcomes. Exploratory endpoints assess objective response rate, depth of response, pathological complete or major response, and R0 resection rate.<br /><br />This innovative integration of induction immunotherapy and chemotherapy with surgery and radiotherapy aims to improve individualized treatment selection, enhance local control, and improve long-term survival for patients with challenging stage III-N3 NSCLC. Results may address limitations of current therapies by increasing operability and reducing local recurrence.

Asset Subtitle

Ailin Li

Meta Tag

Speaker Ailin Li

Topic Clinical Trials in Progress

Keywords

Phase II clinical trial

non-small cell lung cancer

NSCLC stage III-N3

tislelizumab

chemoradiotherapy

immunotherapy consolidation

surgery feasibility

hypofractionated radiotherapy

event-free survival

treatment-naive adults