Clinical trial NCT06321510: A Study to Learn About Dacomitinib in Patients With Non-small Cell Lung Cancer.
Official title: Real-World Treatment Patterns and Clinical Effectiveness of Dacomitinib in Advanced Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor-Positive in Taiwan
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Keywords: EGFR
NSCLC
brain
CNS
dacomitinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer and treated with dacomitnib in medical center or regional hospital will be enrolled.

Brief summary: The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer.

This study is seeking participants who:

* have lung cancer that could not be controlled.
* have a type of gene called epidermoid growth factor receptor. A gene is a part of your DNA that has instructions for making things your body needs to work.
* have received dacomitinib for their lung cancer.

All participants in this study had received dacomitinib. Dacomitinib is a tablet that is taken by mouth at home. They continued to take dacomitnib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.


Eligibility criteria: Inclusion Criteria:

* Evidence of histologically or cytologically confirmed diagnosis of advanced NSCLC with EGFR-activating mutations detected by an appropriate test
* Patients who were treated with dacomitinib as first-line treatment for advanced NSCLC during 01 October 2020 to 31 December 2022.
* Age ≥18 years old
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patients who have been treated with any systemic anti-cancer therapies within 12 months prior to dacomitinib treatment.

Primary outcomes:
measure: Percentage of patients with dacomitinib dosage change and reasons
timeFrame: 52 months from index date
measure: Percentage of patients with dacomitinib treatment discontinuation
timeFrame: 52 months from index date
Secondary outcomes:
measure: Real-world overall survival (rwOS)
timeFrame: 52 months from index date
measure: Real-world progression-free survival
timeFrame: 52 month from index date
measure: Real-world best objective response rate (rwORR)
timeFrame: 52 months from index date
measure: real-world intracranial response rate (rwIC-ORR)
timeFrame: 52 months from index date
measure: real-world extracranial response rate (rwEC-ORR)
timeFrame: 52 months from index date
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: