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

NCT06644495 | Not Yet Recruiting

• 1 other identifier: IRU-PMS-001
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse drug reactions in the overall population

  At enrollment and every 3 months thereafter (up to 3 years)

Secondary Outcomes (4)

• 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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALK-positive advanced non-small cell lung cancer patients who are being treated with Iruplinalkib or planned to receive Iruplinalkib.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Central Study Contacts

CaiCun Zhou, PhD

CONTACT

+86-021-65115006-3050; caicunzhoudr@163.com

Wei Li, PhD

CONTACT

021-38804518-22113; leewluck@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 16, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 16, 2024

Record last verified: 2024-10