CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 5,000 target
Drug / intervention
Iruplinalkibdrug
Likely dose
Iruplinalkib 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05991895
NCT05991895N/ARecruitingOn TrackUpdated 34mo ago

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

Jinming Yu·observational·Posted Aug 15, 2023·Updated Aug 15, 2023

In Brief

An observational study evaluating Iruplinalkib for Non-small Cell Lung Cancer (NSCLC). Currently recruiting, targeting 5,000 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ARecruitingOverdue
202420252026
First PostedAug 15, 2023
Enrollment StartJul 24, 2023
Primary CompletionJul 1, 2026
TodayJul 1, 2026
Enrollment to primary: 2.9 yearsPosted 2.9 years ago

Interventions

Iruplinalkibdrug

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.