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

EGFR Mutation-positive Inoperable or Reccrent NSCLC Clinical Trial

Official title:

Special Investigation for Vizimpro Tablets

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04155541
• Other study ID #: A7471048
• Status: Recruiting
• Start date: January 24, 2020
• Est. completion date: January 4, 2027

Study information

• Verified date: December 2023
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 888
• Est. completion date: January 4, 2027
• Est. primary completion date: January 4, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• EGFR Mutation-positive Inoperable or Reccrent NSCLC

Intervention

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.

Locations

Country	Name	City	State
Japan	Pfizer Japan	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

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