Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer
NCT ID: NCT05991895
Last Updated: 2023-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2023-07-24
2026-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Iruplinalkib
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.
Eligibility Criteria
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Inclusion Criteria
* Patients with ALK-positive non-small cell lung cancer
* Age ≥ 18 years
* Patients who have undergone treatment with Iruplinalkib.
Exclusion Criteria
* Patients with interstitial lung diseases, drug-related pneumonitis, or radiation pneumonitis require ongoing medical intervention.
18 Years
ALL
No
Sponsors
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Jinming Yu
OTHER
Responsible Party
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Jinming Yu
Director of the hospital
Principal Investigators
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JinMing Yu, PhD
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute
Locations
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Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRU-RWS-001
Identifier Type: -
Identifier Source: org_study_id
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