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Status:

RECRUITING

Korea Post Marketing Surveillance (PMS) Study of Vizimpro

Lead Sponsor:

Pfizer

Conditions:

Lung Neoplasms

Eligibility:

All Genders

19+ years

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 ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    March 7 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 14 2026

    Estimated Enrollment :

    180 Patients enrolled

    Trial Details

    Trial ID

    NCT04721106

    Start Date

    March 7 2021

    End Date

    January 14 2026

    Last Update

    November 18 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Pfizer

    Seoul, South Korea