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

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

Completed

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Key information

Conditions

EGFR Mutation-positive Inoperable or Reccrent NSCLC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Japan

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dacomitinib hydrate

Drug

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

Primary outcomes

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.

Secondary outcomes

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.

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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Special Investigation for Vizimpro Tablets

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Nov 7, 2019
Registry last updated: Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed