Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

VIZIMPRO

Medical condition to be studied

EGFR gene mutation
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

300
Study design details

Main study objective

1. To describe demographics, as well as clinical and disease characteristics of patients on first-line dacomitinib therapy for treatment of EGFR mutation-positive advanced NSCLC. 2. To describe starting dose of dacomitinib as first-line therapy, dose modification (if any), related timing and reason for dose modification, interruption or discontinuation. 3. To describe DOT and TTF of dacomitinib

Outcomes

1. Demographics, as well as clinical and disease characteristics of patients on first-line dacomitinib therapy for treatment of EGFR mutation-positive advanced NSCLC. 2. Starting dose of dacomitinib as first-line therapy, dose modification (if any), related timing and reason for dose modification, interruption or discontinuation. 3. DOT and TTF of dacomitinib, 1. Real-world PFS of patients. 2. All adverse events (AEs) for patients treated with dacomitinib. 3. TTF, PFS, overall survival (OS) and AEs, as well as starting dose and dose modification of dacomitinib in a subgroup of patients with common EGFR mutations (exon 19 deletion or exon 21 L858R substitution) enrolled in China.

Data analysis plan

There will be no hypothesis testing in this study. All statistical analyses will be descriptive and no P-values will be reported in this study.