Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer
ConditionNon-small Cell Lung Cancer (NSCLC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJinming Yu
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known pregnant or lactating females
Patients with interstitial lung diseases, drug-related pneumonitis, or radiation pneumonitis require ongoing medical intervention.
Trial population
ALK-positive non-small cell lung cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Iruplinalkib
DrugIruplinalkib 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Adverse Events (AEs)
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jinming Yu
Lead sponsor
Shandong Cancer Hospital and Institute
Sponsor institution
Source ClinicalTrials.gov