Korea Post Marketing Surveillance (PMS) Study of Vizimpro

Lung Neoplasms Clinical Trial

Official title:

A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Vizimpro®

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04721106
• Other study ID #: A7471060
• Status: Enrolling by invitation
• Start date: March 12, 2021
• Est. completion date: March 30, 2026

Study information

• Verified date: September 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: March 30, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Drug:
• Vizimpro
treatment group

Locations

Country	Name	City	State
Korea, Republic of	Pfizer	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events categorized according to physical organ and disease/symptom		From Day 1 of first administration dose up to the date of at least 28 calendar days following the last administration
Secondary	overall response rate	This study is observation, non-intervention study in routine clinical practice. Response rate according to RECIST criteria will be collected under routine clinical practice visit.	Day 1 until progression or drop out of study

External Links

•   To obtain contact information for a study center near you, click here.