Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)
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|ClinicalTrials.gov Identifier: NCT04155541|
Recruitment Status : Active, not recruiting
First Posted : November 7, 2019
Last Update Posted : February 28, 2020
|Condition or disease||Intervention/treatment|
|EGFR Mutation-positive Inoperable or Reccrent NSCLC||Drug: dacomitinib hydrate|
|Study Type :||Observational|
|Estimated Enrollment :||888 participants|
|Official Title:||Special Investigation for Vizimpro Tablets|
|Actual Study Start Date :||January 24, 2020|
|Estimated Primary Completion Date :||December 3, 2024|
|Estimated Study Completion Date :||December 3, 2024|
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 Name: VIZIMPRO
- The number and proportion of patients with ILD (interstitial lung disease) [ Time Frame: 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
- Response rate [ Time Frame: 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.
- The number and popuration of patients with adverse reactions [ Time Frame: 52 weeks from the start date ]The number and popuration of patients with adverse reactions will be tabulated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155541
|Study Director:||Pfizer CT.gov Call Center||Pfizer|