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Neoadjuvant Iruplinalkib and Bevacizumab in ALK-positive NSCLC: A Phase II Single-arm Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This is a single-center, single-arm, prospective phase II trial evaluating iruplinalkib plus bevacizumab as neoadjuvant therapy in ALK-positive NSCLC. Eligible patients receive 4 cycles (Q3W) of iruplinalkib (60 mg lead-in for 7 days, then 180 mg daily, PO) plus bevacizumab (15 mg/kg, IV, D1). Surgery is performed 4 weeks later, followed by adjuvant iruplinalkib monotherapy for up to 2 years. Primary endpoint is major pathological response (MPR) rate; secondary endpoints include safety, R0 resection rate, and survival outcomes.
Trial Details
NCT Number NCT07870733
Lead Sponsor Shanghai Pulmonary Hospital, Shanghai, China
Conditions
(from sponsor)		 ALK, NSCLC, Neoadjuvant Therapy
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov