Non-small Cell Lung Cancer (NSCLC)
Conditions
Brief 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.
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.
Sponsors
Jinming Yu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Known pregnant or lactating females * Patients with interstitial lung diseases, drug-related pneumonitis, or radiation pneumonitis require ongoing medical intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs) | 36 months |
Countries
China
Contacts
Primary ContactJinming Yu, PhD
Backup ContactLinlin Wang, PhD
Outcome results
None listed