NCT05599412RecruitingNot Applicable
A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Lorviqua (Registered)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Pfizer
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Incidence of the adverse events from baseline
Study Overview
Brief 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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •Use in the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
- •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:
- •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.
- •Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
Arms & Interventions
Korean patients with Metastatic ALK+ Non small cell lung cancer
Intervention: Lorviqua (Drug)
Outcomes
Primary Outcomes
Incidence of the adverse events from baseline
Time Frame: 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.
Secondary Outcomes
- Complete Response (CR)(Up to 2 Years)
- Stable Disease (SD)(Up to 2 years)
- Progressive Disease (PD)(Up to 2 years)
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(Up to 2 years)
- Partial Response (PR)(Up to 2 years)
Investigators
Study Sites (1)
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