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OpenTrials
Completed

NCT Number: NCT04721106

Korea Post Marketing Surveillance (PMS) Study of Vizimpro

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.

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Key information

Conditions

Lung Neoplasms Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vizimpro

Drug

treatment group

Primary outcomes

  1. 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

  1. overall response rate

    Time frame: Day 1 until progression or drop out of study

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2021
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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