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Iruplinalkib Combined With Bevacizumab as Neoadjuvant Therapy for ALK-positive NSCLC
NCT07870733Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Sep 2026
- Primary completion
- Jul 2029
- Sponsor
- Shanghai Pulmonary Hospital
- Drugs
- iruplinalkib
- Conditions
- non-small cell lung cancer (NSCLC)
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Overview
Phase 2, open-label, single-arm trial of iruplinalkib in non-small cell lung cancer (NSCLC), sponsored by Shanghai Pulmonary Hospital. Primary endpoints: Pathological complete response rate at 30 months and Major pathological response rate at 30 months. Planned start Sep 2026; status: not yet recruiting.
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Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Bevacizumab combined with iruplinalkib
Neoadjuvant iruplinalkib + bevacizumab followed by surgery and adjuvant iruplinalkib monotherapy.
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Who it enrols
Adults aged 18-80 with stage II-III ALK-positive NSCLC, ECOG 0-1, and adequate organ function. Excludes patients with prior systemic therapy for NSCLC, mixed histology, or history of ILD.
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Endpoints
Primary
Pathological complete response rate
Major pathological response rate
Secondary
Progression-free survival
Safety
R0 resection rate
Survival outcomes
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