NCT05599412 Post Marketing Surveillance(PMS) Study of Lorviqua in Korea
| NCT ID | NCT05599412 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pfizer |
| Condition | Metastatic ALK+ Non Small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-05-22 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2023-05-22 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT05599412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic ALK+ Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05599412 currently recruiting?
Yes, NCT05599412 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT05599412 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05599412 clinical trial?
NCT05599412 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 600 participants.
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