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

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

Inclusion Criteria4

  • Patients willingly contribute their clinical data for this study
  • Patients with ALK-positive non-small cell lung cancer
  • Age ≥ 18 years
  • Patients who have undergone treatment with Iruplinalkib.

Exclusion Criteria2

  • Known pregnant or lactating females
  • Patients with interstitial lung diseases, drug-related pneumonitis, or radiation pneumonitis require ongoing medical intervention.

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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