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

NCT04155541 | Completed Results

• 1 other identifier: A7471048
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

EGFR Mutation-positive Inoperable or Reccrent NSCLC

Keywords

VIZIMPRO; EGFR mutation-positive inoperable or recurrent NSCLC; non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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 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"

  52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation.

Study Arms (1)

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

Interventions

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.

Also known as: VIZIMPRO

VIZIMPRO(dacomitinib hydrate)

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Japan

Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

dacomitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: January 24, 2020
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: June 11, 2026
• Results First Posted: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)