Korea Post Marketing Surveillance (PMS) Study of Vizimpro

Launched by PFIZER · Jan 20, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called Vizimpro, which is used to treat a type of lung cancer known as non-small cell lung cancer (NSCLC) that has specific genetic changes called EGFR mutations. The study is taking place in Korea to observe how well Vizimpro works and how safe it is when used in everyday medical practice, after it has been approved for use. This kind of study is important to make sure the medicine continues to help patients without causing unexpected problems.

People eligible to join the study are adults with advanced or metastatic NSCLC who have not taken Vizimpro before and who have the specific EGFR mutations that Vizimpro targets. Participants must be able to give consent to be part of the study. However, people who are allergic to Vizimpro or who have certain rare conditions that affect how their body handles lactose (a sugar found in the medicine) cannot join. Those who agree to take part will be closely monitored to check how well the treatment is working and to watch for any side effects, helping doctors understand the medicine’s effects in real-world use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
• • 1. 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
• • 2. 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
• • Exclusion criteria
• Patients meeting any of the following criteria will not be included in the study:
• • 1. 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.
• • B. 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.
• • 2. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.