Post-Market Surveillance Study of ALK-Positive Advanced NSCLC Participants Treated With Iruplinalkib

Not yet recruiting

• Conditions: NSCLC

• Registration Number: NCT06644495
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

The goal of this observational study is to evaluate the safety and efficacy of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with Iruplinalkib or planned to receive Iruplinalkib treatment in real-world clinical practice.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Study Start: 2024-12
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Pathologically confirmed patients with locally-advanced or metastatic ALK-positive non-small cell lung cancer.
• Currently receiving, or planned to receive treatment with Iruplinalkib.
• Subjects had imaging reports of chest and abdominal enhanced CT and brain MRI within 42 days prior to the first dose of Iruplinalkib as 1L treatment for locally-advanced or metastatic ALK-positive non-small cell lung cancer.
• Subjects had routine and biochemical reports within 30 days prior to the first dose of Iruplinalkib as 1L treatment for locally-advanced or metastatic ALK-positive non-small cell lung cancer.

Exclusion Criteria

• Patients who had previously been treated with ALK-TKI, but who had previously only been treated with ALK-TKI as neoadjuvant and/or adjunctive treatment could be enrolled.
• Mental disorder or inability to cooperate with examination or follow-up.
• Women known to be pregnant or lactating.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of adverse drug reactions in the overall population	At enrollment and every 3 months thereafter (up to 3 years)

Secondary Outcome Measures

Name	Time	Method
The incidence of greater than or equal to grade 3 AEs, SAEs, AEs resulting in dose reduction/interruption/discontinuation, AESIs, and AEs resulting in death in the overall population	At enrollment and every 3 months thereafter (up to 3 years)
Real-world progression-free survival (rwPFS) for 1L treatment with Iruplinalkib	From the first administration of Iruplinalkib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 3 years).
Time to treatment failure (TTF) for 1L treatment with Iruplinalkib	From the first administration of Iruplinalkib to the date of first documentation of discontinuation of Iruplinalkib due to any cause (up to 3 years).
Event to first follow-up treatment or death (TFST) for 1L treatment with Iruplinalkib	From the first administration of Iruplinalkib to the date of first documentation of initiation of next line of treatment, or death due to any cause, whichever occurs first (up to 3 years).