A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Vizimpro®
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events categorized according to physical organ and disease/symptom
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients meeting any of the following criteria will not be included in the study:
- •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.
- •Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
Arms & Interventions
Vizimpro treatment group
This group is included the patients that Vizimpro are prescribed and administrated according to local label in the routine clinical practice
Intervention: Vizimpro (Drug)
Outcomes
Primary Outcomes
Incidence of adverse events categorized according to physical organ and disease/symptom
Time Frame: From Day 1 of first administration dose up to the date of at least 28 calendar days following the last administration
Secondary Outcomes
- overall response rate(Day 1 until progression or drop out of study)