Clinical trial NCT06644495: Post-Market Surveillance Study of ALK-Positive Advanced NSCLC Participants Treated With Iruplinalkib
Official title: Post-Market Surveillance Study of ALK-Positive Advanced NSCLC Participants Treated With Iruplinalkib
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: NSCLC
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of adverse drug reactions in the overall population
timeFrame: At enrollment and every 3 months thereafter (up to 3 years)
Secondary outcomes:
measure: 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
timeFrame: At enrollment and every 3 months thereafter (up to 3 years)
measure: Real-world progression-free survival (rwPFS) for 1L treatment with Iruplinalkib
timeFrame: 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).
measure: Time to treatment failure (TTF) for 1L treatment with Iruplinalkib
timeFrame: From the first administration of Iruplinalkib to the date of first documentation of discontinuation of Iruplinalkib due to any cause (up to 3 years).
measure: Event to first follow-up treatment or death (TFST) for 1L treatment with Iruplinalkib
timeFrame: 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).
Other outcomes:
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