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

Special Investigation for Vizimpro Tablets

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

Study Overview

• Status: Completed
• Conditions: EGFR Mutation-positive Inoperable or Reccrent NSCLC
• Intervention / Treatment: Drug: dacomitinib hydrate

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Pfizer Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Exclusion criteria is not provided in this study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VIZIMPRO(dacomitinib hydrate); Patients with EGFR mutation-positive inoperable or recorrent NSCLN (non-small cell lung cancer) who have not received VIZIMPRO (dacomitinib hydrate)	Drug: dacomitinib hydrate; 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.; Other Names: VIZIMPRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation.

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): April 25, 2025
• Study Completion (Actual): April 25, 2025

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; VIZIMPRO; EGFR mutation-positive inoperable or recurrent NSCLC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Tyrosine Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; dacomitinib
• Other Study ID Numbers: A7471048; NCT04155541 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan 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.