RecruitingEarly Phase 1NCT06436885

An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer


Sponsor

Henan Cancer Hospital

Enrollment

39 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open, multicenter exploratory clinical trial to observe and evaluate the efficacy and safety of Iruplinalkib Tablets in patients with ROS1 positive non-small cell lung cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests iruplinalkib, a targeted drug that blocks an abnormal protein called ROS1, in patients with non-small cell lung cancer (NSCLC) that carries a specific ROS1 gene change. ROS1-positive lung cancers are driven by this gene alteration, and targeted drugs can block it. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage III (unresectable) or stage IV NSCLC with a confirmed ROS1-positive gene change - Your cancer has at least one measurable tumor - You are in good general health (ECOG performance status 0–2) - You are able to swallow pills - Brain metastases are allowed if they are asymptomatic or have been stable for at least 4 weeks after treatment **You may NOT be eligible if...** - You are currently in another clinical trial using a different investigational drug - You have mixed small cell and non-small cell lung cancer - You have severe heart problems or a significant history of cardiovascular/cerebrovascular disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIruplinalkib tablets

Iruplinalkib tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet


Locations(1)

Henan cancer hospital

Zhengzhou, Henan, China

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NCT06436885


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