Korea Post Marketing Surveillance (PMS) Study of Vizimpro | NCT04721106

Studies
Korea Post Marketing Surveillance (PMS) Study of Vizimpro

NCT04721106

Sponsor

Pfizer

Status

Completed

Last Update Posted

Feb 10, 2026Actual

Enrollment

188Actual

Phase

Not provided

Conditions

Lung Neoplasms

Interventions

Vizimpro

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCT04721106	Registry Identifier	ClinicalTrials.gov

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2021Actual

Primary Completion Date

Jan 19, 2026Actual

Completion Date

Jan 19, 2026Actual

First Submitted Date

Jan 13, 2021

First Submission Date that Met QC Criteria

Jan 20, 2021

First Posted Date

Jan 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2026

Last Update Posted Date

Feb 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

188Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vizimpro treatment group		This group is included the patients that Vizimpro are prescribed and administrated according to local label in the routine clinical practice	Drug: Vizimpro

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vizimpro	Drug	treatment group	Vizimpro treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients to whom Vizimpro can be prescribed as per the local labeling (the first-line treatment of adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor EGFR-activating mutations

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms