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 proportion of patients with ILD (interstitial lung disease)	The number and proportion of patients with ILD (interstitial lung disease) will be tabulated by subgroup by risk factor	52 weeks form the start date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	Response rate will be calculated. The response rate is defined as the propotion of patients with a best ovarall response of CR ro PR in the effectiveness analysis set.	52 weeks from the start date
The number and population of patients with adverse reactions	The number and population of patients with adverse reactions will be tabulated.	52 weeks from the start date

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): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

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: 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.