Post Marketing Surveillance(PMS) Study of Lorviqua in Korea

Trial Title: Post Marketing Surveillance(PMS) Study of Lorviqua in Korea

NCT ID: NCT05599412

Condition: Metastatic ALK+ Non Small Cell Lung Cancer

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Lorviqua
Description: As provided in real world practice
Arm group label: Korean patients with Metastatic ALK+ Non small cell lung cancer

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

Criteria for eligibility:

Study pop:
Korean patient who has a disease for which Lorlatinib is indicated

Sampling method: Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Pfizer

Address:
City: Seoul
Zip: 01037
Country: Korea, Republic of

Status: Recruiting

Start date: May 22, 2023

Completion date: August 10, 2028

Lead sponsor:
Agency: Pfizer
Agency class: Industry

Source: Pfizer

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05599412
https://pmiform.com/clinical-trial-info-request?StudyID=B7461034