Post Marketing Surveillance(PMS) Study of Lorviqua in Korea

Pfizer

Status: Enrolling

Conditions: Metastatic ALK+ Non Small Cell Lung Cancer

Treatments: Drug: Lorviqua

Study type: Observational

Funder types: Industry

Identifiers

NCT05599412

B7461034

NCT05599412 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Korean patients with Metastatic ALK+ Non small cell lung cancer

Treatment:

Drug: Lorviqua