Monitoring the use of Lorviqua for lung cancer in Korea
A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Lorviqua (Registered)
This study looks at how well Lorviqua works and its side effects in people with a specific type of lung cancer in Korea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05599412 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor the real-world usage of Lorviqua in patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) in Korea. It will track the treatment's effectiveness and any adverse events associated with its use. Patients will be required to provide informed consent to participate in the study, ensuring they understand the study's purpose and procedures. The study will focus on collecting data from clinical practice to better understand the drug's safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients diagnosed with ALK-positive metastatic non-small cell lung cancer who are eligible for treatment with Lorviqua.
Not a fit: Patients who are contraindicated for Lorviqua treatment or have specific hypersensitivities will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of Lorviqua for patients with metastatic ALK+ NSCLC.
How similar studies have performed: While this study is observational and focuses on post-marketing surveillance, similar studies have successfully monitored real-world drug usage and safety, providing important data for treatment optimization.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Pfizer — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.