NCT04721106Completed
Korea Post Marketing Surveillance (PMS) Study of Vizimpro
A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Vizimpro®
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
Vizimpro will be approved for the treatment of EGFR NSLCL 1L in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Vizimpro after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Vizimpro will be observed.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 188 (actual)
- First submitted
- 13 Jan 2021
- Start date
- 7 Mar 2021
- Primary completion date
- 19 Jan 2026
- Lead sponsor
- Pfizer
- Diseases
- Lung cancer
- NCT number
- NCT04721106
What you commit to
- Study type: Observational
- Participants enrolled: 188
- From 7 Mar 2021 to the primary completion date, 19 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Patients to whom Vizimpro® is contraindicated as per the local labeling. A. Hypersensitivity to the active substance or to any of the excipients of this product.
- This medicinal product contains lactose. Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Other
- Patients meeting any of the following criteria will not be included in the study:
- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
Who the study is looking for
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Vizimpro® naïve patients to whom Vizimpro® can be prescribed as per the local labeling (the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations
- Evidence of a 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.