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

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.

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

The incidence of adverse drug reactions in the overall population

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

Secondary outcomes

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

Time frame: At enrollment and every 3 months thereafter (up to 3 years)
Real-world progression-free survival (rwPFS) for 1L treatment with Iruplinalkib

Time frame: 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

Time frame: 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

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

CaiCun Zhou, PhD

CONTACT

[email protected]

+86-021-65115006-3050

Wei Li, PhD

CONTACT

[email protected]

021-38804518-22113

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Oct 16, 2024
Registry last updated: Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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