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

NCT07330076 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-01-09

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • zhenfa Zhang, M.D · Department of lung cancer, Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-06
Primary Completion
2030-12-31
Completion
2031-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07330076 on ClinicalTrials.gov