Post Marketing Surveillance(PMS) Study of Lorviqua in Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lorviqua.
- Who it may be relevant to
- Registry conditions: Metastatic ALK+ Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Lorviqua (Registered)
Overview
The objective of this study is to monitor the usage of Lorviqua in real practice within label, including the adverse events associated with Lorviqua
Interventions
- Drug Lorviqua
As provided in real world practice
Primary outcome measures
- Incidence of the adverse events from baseline [Time frame: Up to 2 years]
Secondary outcome measures (5)
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [Time frame: Up to 2 years]
- Partial Response (PR) [Time frame: Up to 2 years]
- Stable Disease (SD) [Time frame: Up to 2 years]
- Progressive Disease (PD) [Time frame: Up to 2 years]
- Complete Response (CR) [Time frame: Up to 2 Years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
South Korea · 1 center
- Pfizer — Seoul
Identifiers
NCT: NCT05599412 · B7461034 · NCT05599412