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.
Signed informed consent.
Hypersensitivity to iruplinalkib, bevacizumab, or any excipients.
Single group
Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC:
DrugEligible patients receive 4 cycles (Q3W) of bevacizumab (15 mg/kg IV on D1) plus iruplinalkib (60 mg oral lead-in for 7 days, then 180 mg daily). Surgery is performed 4 weeks after neoadjuvant therapy, followed by adjuvant iruplinalkib monotherapy for up to 2 years (starting within 4-8 weeks post-surgery), continued until progression, unacceptable toxicity, or loss of benefit.
Pathological complete response (pCR) rate
The proportion of subjects undergoing lung cancer resection who have no residual viable tumor cells in both the postoperative tumor bed and lymph nodes.
Progression-free survival (PFS)
Time from enrollment to tumor progression or death from any cause, whichever occurs first.
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This trial is not recruiting at the moment. You can still explore other options:
