EGFR Mutation-positive Inoperable or Reccrent NSCLC
Conditions
Keywords
VIZIMPRO, EGFR mutation-positive inoperable or recurrent NSCLC, non-small cell lung cancer
Brief summary
Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice
Interventions
DRUGdacomitinib 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.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient with EGFR mutation-positive inoprable or recurrent NSCLC who have not received VIZIMPRO(dacomitinib hydrate)
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number and Percentage of Participants With Interstitial Lung Disease (ILD) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Japan
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized ≥15 and <65 years | 10 participants |
| Age, Customized <15 years | 0 participants |
| Age, Customized ≥65 years | 28 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 38 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 3 / 38 |
Outcome results
None listed