Monitoring the use of Lorviqua for lung cancer in Korea
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Lorviqua (Registered)
Run by Pfizer · NCT05599412 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | May 22, 2023 |
| Main results expected | January 31, 2028 |
| Study ends | January 31, 2028 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT05599412 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who are contraindicated for Lorviqua treatment or have specific hypersensitivities will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
NXP900 with Lorlatinib in ALK-positive NSCLC
This study tests whether adding NXP900 to lorlatinib helps people with ALK-positive non-small cell lung cancer who have already received prior therapy.
-
AQUA07 in ALK-positive NSCLC (phase 1)
This early-stage trial tests AQUA07 alone and with lorlatinib to see if it is safe and tolerable for adults with ALK-positive non-small cell lung cancer who have tried other ALK inhibitors.
-
TRI-611 for ALK-positive non-small cell lung cancer (Phase 1/2)
This trial will test TRI-611 to see if it is safe and can shrink tumors in adults with ALK-positive non-small cell lung cancer, including people with different past ALK treatments.
-
Observational study of lorlatinib for advanced ALK-positive lung cancer patients
This study looks at how well lorlatinib works and how safe it is for people with advanced ALK-positive lung cancer who are receiving treatment.
-
First-line treatment with lorlatinib for advanced ALK+ lung cancer in China
This study is testing if lorlatinib can be an effective first treatment for people in China with advanced ALK-positive lung cancer.
-
Supportive care model for patients with advanced lung cancer
This study is testing a new supportive care program for people with advanced lung cancer to see if it helps them feel less stressed and more confident about managing their condition compared to standard care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.