Lung NeoplasmsNCT04721106
Korea Post Marketing Surveillance (PMS) Study of Vizimpro
An observational study of Lung Neoplasms, run by Pfizer at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Vizimpro
- How many people
- 188 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Mar 2021to 19 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, 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.
- Conditions
- Lung Neoplasms
- Being tested
- Vizimpro
- Keywords
- EGFR NSCLC
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VizimproDrug
treatment group
| Study group | Role | What they receive |
|---|---|---|
| Vizimpro treatment group | This group is included the patients that Vizimpro are prescribed and administrated according to local label in the routine clinical practice Receives: Drug: Vizimpro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events categorized according to physical organ and disease/symptom
Measured: 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
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.
Measured: Day 1 until progression or drop out of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start7 Mar 2021
- Primary completion19 Jan 2026
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721106
- Sponsor's protocol ID
- A7471060
- Other IDs
- NCT04721106
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Vizimpro®
- ClinicalTrials.gov ID
- NCT04721106
- Acronym / sponsor ID
- A7471060
- Conditions
- Lung Neoplasms
- Keywords
- EGFR NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vizimpro treatment group | – | Drug: VizimproThis group is included the patients that Vizimpro are prescribed and administrated according to local label in the routine clinical practice |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vizimprotreatment group | Drug | Vizimpro treatment group |
Primary outcome
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
1 secondary outcome
overall response rate
Time frame: Day 1 until progression or drop out of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.