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NOT YET RECRUITING
NCT07330076
PHASE2

Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC With High-risk Factors

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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

DRUG

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.