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Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC With High-risk Factors
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
The primary objective is to evaluate the efficacy and safety of Iruplinalkib Tablets as postoperative adjuvant therapy in patients with stage IA, ALK-positive NSCLC with high-risk factors.
Official title: Protocol for a Prospective, Single-arm, Multicenter Clinical Study on the Efficacy and Safety of Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC With High-risk Factors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2026-01-06
Completion Date
2031-12-31
Last Updated
2026-01-09
Healthy Volunteers
No
Conditions
Interventions
Iruplinalkib tablets
Iruplinalkib: Refer to the drug insert. The tablets should be swallowed whole and must not be crushed, divided, or chewed. The recommended dosage is once daily, which can be taken on an empty stomach or with food. From Day 1 to Day 7, the dose is 60mg per administration. If tolerated, the dose should be increased to 180mg per administration starting from Day 8, and continued until disease progression, intolerable toxicity, or completion of the 2-year treatment period.If a subject misses a scheduled dose, it should be taken within 8 hours of the missed time; doses missed by more than 8 hours should not be made up. If vomiting occurs after taking a dose, no additional dose should be taken. The investigator will assess whether to continue with the next scheduled dose.