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Trial Title:
Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer
NCT ID:
NCT05991895
Condition:
Non-small Cell Lung Cancer (NSCLC)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Iruplinalkib
Description:
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.
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.
Criteria for eligibility:
Study pop:
ALK-positive non-small cell lung cancer
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong Cancer Hospital and Institute
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Linlin Wang
Phone:
+8613793187739
Email:
wanglinlinatjn@163.com
Start date:
July 24, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Jinming Yu
Agency class:
Other
Source:
Shandong Cancer Hospital and Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05991895
