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Clinical Trials in South Korea / NCT05599412
Recruiting Observational

Post Marketing Surveillance(PMS) Study of Lorviqua in Korea

NCT05599412 · tracked via the Priya Life Science South Korea tracker
Sponsor
Pfizer
Phase
Observational
Started
2023-05-22
Last updated
2026-03-27

Condition(s) studied

Metastatic ALK+ Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Lorviqua →

Lorviqua: As provided in real world practice

Study summary

The objective of this study is to monitor the usage of Lorviqua in real practice within label, including the adverse events associated with Lorviqua

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Use in the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) 2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study: 1. Patients to whom Lorviqua® is contraindicated as per the local labeling. A. Hypersensitivity to Lorviqua® or to any of the excipients of this product B. Lorviqua® is contraindicated in patients taking concomitant use of strong CYP3A4/5 inducers C. This medicinal product contains lactose as an excipient. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose galactose malabsorption should not take this medicinal product. 2. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information

Primary outcome measure(s)

  • Incidence of the adverse events from baseline — Up to 2 years
    This is a prospective, observational, non-interventional, multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians.

Trial sites (1)

FacilityCityRegionStatus
Pfizer Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05599412 on ClinicalTrials.gov ↗ ← All trials in South Korea