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.
This Prospective, Single-arm, Multicenter Clinical Study aims to evaluate the Efficacy and Safety of Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC with High-risk Factors.This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
3-year DFS rate
Defined as the proportion of patients who have not experienced disease progression or death from any cause from the initiation of Iruplinalkib treatment until the end of the third year.
Time frame: Up to 36 months
Overall Survival (OS)
The time from the start of treatment until death.
Time frame: Time Frame: up to 36 month
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