EGFR Mutation-positive Inoperable or Reccrent NSCLCNCT04155541

Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)

An observational study of EGFR Mutation-positive Inoperable or Reccrent NSCLC, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice Read more about this study

Who is it for?: Ages 0 years and older
Conditions the study is for: EGFR Mutation-positive Inoperable or Reccrent NSCLC
What is being tested?: dacomitinib hydrate
Type of treatment: Pill or oral medicine
How many people: 40 participants
Where: 1 siteJapan
Study dates: 24 Jan 2020to 25 Apr 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 0 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The patient who meet the inclusion criteria and who were registered to this study within 84 days including the start date of treatment with this product will be subjects for this study.

Who may be able to join

patient with EGFR mutation-positive inoprable or recurrent NSCLC who have not received VIZIMPRO(dacomitinib hydrate)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Pfizer Japan
Tokyo

Other trials in Japan

About this study

Official title: Special Investigation for Vizimpro Tablets

Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice

Conditions: EGFR Mutation-positive Inoperable or Reccrent NSCLC
Being tested: dacomitinib hydrate
Keywords: VIZIMPRO, EGFR mutation-positive inoperable or recurrent NSCLC, non-small cell lung cancer
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dacomitinib hydrateDrug
Also called VIZIMPRO
The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose should be reduced appropriately according to the patient's condition.

Study groups in NCT04155541
Study group	Role	What they receive
VIZIMPRO(dacomitinib hydrate)		Patients with EGFR mutation-positive inoperable or recorrent NSCLN (non-small cell lung cancer) who have not received VIZIMPRO (dacomitinib hydrate) Receives: Drug: dacomitinib hydrate

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number and Percentage of Participants With Interstitial Lung Disease (ILD)
An adverse drug reaction (ADR) was a treatment-related adverse event (AE), and any untoward medical occurrence attributed to VIZIMPRO Tablets 15mg and/or 45mg in a participant who received this drug. A serious ADR was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly/birth defect. Relatedness to this drug was assessed.
This study focused on ILD, but an ADR other than ILD was also included in the analysis.
Measured: 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).

Secondary outcomes (1)

Assessment of Response Rate: Assess the Response Rate According to the "Response Evaluation Criteria in Solid Tumors Guidelines (RECIST) - Revised Version 1.1"
The response rate was calculated based on the best overall response as evaluated by the physician in accordance with the RECIST - Revised Version 1.1.
The response rate was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR).
In addition, the response rate and its two-sided 95% confidence interval (using exact method) were calculated. The participants not reported response were considered to have achieved a best overall response other than CR or PR.
Measured: 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 202025 Apr 2025

First posted7 Nov 2019
Study start24 Jan 2020
Primary completion25 Apr 2025
Study completion25 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EGFR Mutation-positive Inoperable or Reccrent NSCLCStudies 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04155541
Sponsor's protocol ID: A7471048
Status last verified: May 2026
First submitted: 5 Nov 2019
Last updated: 11 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Investigation for Vizimpro Tablets
ClinicalTrials.gov ID: NCT04155541
Acronym / sponsor ID: A7471048
Conditions: EGFR Mutation-positive Inoperable or Reccrent NSCLC
Keywords: VIZIMPRO, EGFR mutation-positive inoperable or recurrent NSCLC, non-small cell lung cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 24 Jan 2020 (actual)
Primary completion: 25 Apr 2025 (actual)
Study completion: 25 Apr 2025 (actual)
First posted: 7 Nov 2019 (actual)
Results: Posted 11 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
VIZIMPRO(dacomitinib hydrate)	–	Drug: dacomitinib hydratePatients with EGFR mutation-positive inoperable or recorrent NSCLN (non-small cell lung cancer) who have not received VIZIMPRO (dacomitinib hydrate)

Who may qualify

Ages: 0 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The patient who meet the inclusion criteria and who were registered to this study within 84 days including the start date of treatment with this product will be subjects for this study.

Key inclusion criteria (1 listed)

patient with EGFR mutation-positive inoprable or recurrent NSCLC who have not received VIZIMPRO(dacomitinib hydrate)

Key exclusion criteria (0 listed)

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
dacomitinib hydrateAlso: VIZIMPROThe usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose should be reduced appropriately according to the patient's condition.	Drug	VIZIMPRO(dacomitinib hydrate)

Primary outcome

The Number and Percentage of Participants With Interstitial Lung Disease (ILD)
Time frame: 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).
An adverse drug reaction (ADR) was a treatment-related adverse event (AE), and any untoward medical occurrence attributed to VIZIMPRO Tablets 15mg and/or 45mg in a participant who received this drug. A serious ADR was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly/birth defect. Relatedness to this drug was assessed. This study focused on ILD, but an ADR other than ILD was also included in the analysis.

1 secondary outcome

Assessment of Response Rate: Assess the Response Rate According to the "Response Evaluation Criteria in Solid Tumors Guidelines (RECIST) - Revised Version 1.1"
Time frame: 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation.

Results and safety

Results posted to the registry on 11 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VIZIMPRO Tablets 15mg and/or 45mg (Dacomitinib) Single Arm	40	38

Primary outcome: The Number and Percentage of Participants With Interstitial Lung Disease (ILD)

Time frame: 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).. Count of participants. Unit: Participants

Measure	VIZIMPRO Tablets 15mg and 45mg (Dacomitinib) n = 38
ADR	1
Serious ADR	1
ILD	0
Rash	1

Population analysed: The SAS (38 participants) comprised of participants who satisfied the inclusion criteria and had received VIZIMPRO Tablets 15mg and/or 45mg. Participants who did not provide informed consent were excluded.

1 secondary outcome is reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
VIZIMPRO Tablets 15mg and 45mg (Dacomitinib)	3 of 38 (7.9%)	0 of 38 (0%)	2 of 38

Limitations and caveats (from the sponsor): The implementation plan stipulated that only ILD among the observed AEs was to be collected. Although events other than ILD were also collected and included in the analysis, such collection was not originally intended under the plan. Consequently, the occurrence status of non-ILD events is not considered to accurately reflect the actual situation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

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 EGFR Mutation-positive Inoperable or Reccrent NSCLC, run by Pfizer at 1 site in Japan.

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 1 inclusion and 0 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 11 Jun 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 Japan. 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?

Yes. Results are posted in the registry (first posted 11 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Number and Percentage of Participants With Interstitial Lung Disease (ILD) (time frame: 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04155541.

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 11 Jun 2026.