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

Completed

• Conditions: EGFR Mutation-positive Inoperable or Reccrent NSCLC
• Interventions: Drug: dacomitinib hydrate

• Registration Number: NCT04155541
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2020-01-24
• Primary Completion: 2025-04-25
• Study Completion: 2025-04-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VIZIMPRO(dacomitinib hydrate)	dacomitinib hydrate	Patients with EGFR mutation-positive inoperable or recorrent NSCLN (non-small cell lung cancer) who have not received VIZIMPRO (dacomitinib hydrate)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The number and population of patients with adverse reactions	52 weeks from the start date	The number and population of patients with adverse reactions will be tabulated.
Response rate	52 weeks from the start date	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.

Trial Locations

Locations (1)

Pfizer Japan; 🇯🇵 Tokyo, Japan