Post Marketing Surveillance(PMS) Study of Lorviqua in Korea
Recruiting · NCT05599412 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Lorviqua
What this trial is 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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Pfizer - Seoul, South Korea