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RecruitingNCT05991895Updated Aug 15, 2023

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

An observational study in Non-small Cell Lung Cancer (NSCLC), sponsored by Jinming Yu. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-15.

Sponsored by Jinming Yu · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-small Cell Lung Cancer (NSCLC)
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Jinming Yu is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

ALK-positive non-small cell lung cancer

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

Exclusion Criteria:

  • Known pregnant or lactating females
  • Patients with interstitial lung diseases, drug-related pneumonitis, or radiation pneumonitis require ongoing medical intervention.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No

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.

06

What researchers measure

Primary outcomes

  1. Adverse Events (AEs)

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
  • Shandong Cancer Hospital and Institute
    Jinan, Shandong, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05991895
Lead sponsor
Jinming Yu
Responsible party
Jinming Yu (Director of the hospital, Shandong Cancer Hospital and Institute) — Sponsor-investigator
First posted
Aug 15, 2023
Start date
Jul 24, 2023
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Aug 15, 2023

Study contacts

Jinming Yu, PhD
Contact
jn7984729@public.jn.sd.cn
8613806406293
Linlin Wang, PhD
Contact
wanglinlinatjn@163.com
8613793187739
JinMing Yu, PhD
principal investigator · Shandong Cancer Hospital and Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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