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

• Sponsor: Jinming Yu (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05991895
• Collaborator: (none)
• Enrollment: 5,000
• Location: 1
• Anticipated Duration (Months): 35.3
• Patients Per Site Per Month: 141.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer (NSCLC)	Drug: Iruplinalkib

Study Design

• Study Type: Observational
• Anticipated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer
• Actual Study Start Date: Jul 24, 2023
• Anticipated Primary Completion Date: Jul 1, 2026
• Anticipated Study Completion Date: Jul 1, 2026

Outcome Measures

Primary Outcome Measures

1. Adverse Events (AEs) [36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shandong Cancer Hospital and Institute	Jinan	Shandong	China

Sponsors and Collaborators

• Jinming Yu

Investigators

• Principal Investigator: JinMing Yu, PhD, Shandong Cancer Hospital and Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jinming Yu, Director of the hospital, Shandong Cancer Hospital and Institute
• ClinicalTrials.gov Identifier: NCT05991895
• Other Study ID Numbers: IRU-RWS-001
• First Posted: Aug 15, 2023
• Last Update Posted: Aug 15, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Aug 15, 2023