RecruitingNCT05991895

Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer

Sponsor

Jinming Yu

Enrollment

5,000 participants

Start Date

Jul 24, 2023

Study Type

OBSERVATIONAL

Conditions

Non-small Cell Lung Cancer (NSCLC)

Summary

This study is a national multicenter real-world investigation aimed at evaluating the real-world effectiveness and safety of Iruplinalkib in the treatment of ALK-positive NSCLC in China. The study aims to enroll ALK-positive NSCLC patients who have undergone treatment with Iruplinalkib prior to enrollment. Demographic information, medical history, Iruplinalkib-containing treatment regimens, clinical outcomes, adverse events, and related data will be collected for all enrolled patients. As this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. The primary sources of data for this study will mainly consist of patients' routine medical records or healthcare documentation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This real-world study is collecting information about how a drug called iruplinalkib works for people with a specific type of lung cancer (ALK-positive non-small cell lung cancer). It is observational, meaning researchers just track outcomes without changing your treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with ALK-positive non-small cell lung cancer - You have already received treatment with iruplinalkib - You agree to share your medical data for the study **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an ongoing lung condition like interstitial lung disease or radiation pneumonitis that requires active treatment 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

Iruplinalkib is administered orally with approximately fixed dosing times each day. The recommended dosage is once daily, on an empty stomach or with food, at 60 mg per dose for the first 1 to 7 days. If tolerated, the dosage is increased to 180 mg per dose starting from the 8th day.

Locations(1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

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NCT05991895

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