Clinical trial NCT06075615: A Study to Learn About Dacomitnib in Patients With Non-small Cell Lung Cancer Which Has Spread to the Brain.
Official title: A Multicenter, Observational Study to Describe the Effectiveness and Treatment Patterns of Dacomitinib Among Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer Patients With Brain Metastasis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Dacomitinib, Non-Small Cell Lung Cancer, Brain Metastasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with epidermoid growth factor receport (EGFR)-positive non-small cell lung cancer (NSCLC) with brain metastasis

Brief summary: The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer which has spread to other parts of the body.

This study is seeking participants who:

* have lung cancer that has reached at least the brain.
* 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 not received any treatment before.

All participants in this study will receive dacomitnib 1 time a day. Dacomitinib is a tablet that is taken by mouth at home. They can continue to take dacomitnib until their cancer is 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:

* at least 18 years old
* confirmed diagnosis of EGFR mutation-positive NSCLC
* at least one measurable intracranial metastasis
* ECOG-PS of 0, 1 or 2
* dacomitinib as first-line treatment for advanced NSCLC
* Evidence of a personally signed and dated informed consent document (ICD)

Exclusion Criteria:

* any anti-cancer systemic treatment within 12 months prior to index date
* currently on active investigational drug(s) treatment in other clinical studies (Phase 1-4) within 2 weeks before the current study begins and/or during study participation.

Primary outcomes:
measure: The real-world intracranial overall response rate (rwICORR) at Month 3
timeFrame: 3 months from first dose of dcomitnib
measure: The real-world intracranial overall response rate (rwICORR) at Month 6
timeFrame: 6 months from first dose of dacomitnib
measure: The real-world intracranial overall response rate (rwICORR) at Month 12
timeFrame: 12 months from first dose of dacomitinib
measure: The real-world intracranial clinical benefit rate (rwICBR) at Month 3
timeFrame: 3 months from first dose of dacomitinib
measure: The real-world intracranial clinical benefit rate (rwICBR) at Month 6
timeFrame: 6 months from first dose of dacomitinib
measure: The real-world intracranial clinical benefit rate (rwICBR) at Month 12
timeFrame: 12 months from first dose of dacomitinib
measure: The real-world intracranial time to progression (rwICTTP)
timeFrame: 30 months from first dose of dacomitinib
measure: The real-world systemic overall response rate (rwORR) at Month 3
timeFrame: 3 months from first dose of dacomitinib
measure: The real-world systemic overall response rate (rwORR) at Month 6.
timeFrame: 6 months from first dose of dacomitinib
measure: The real-world systemic overall response rate (rwORR) at Month 12.
timeFrame: 12 months from first dose of dacomitinib
measure: The real-world progression-free survival (rwPFS) during 12 months from index date
timeFrame: 12 months from index date
measure: The real-world overall survival (rwOS) during 12 months from index date
timeFrame: 12 months from index date
measure: The real-world overall survival (rwOS) during 24 months from index date
timeFrame: 24 months from index date
Secondary outcomes:
measure: Percentage of patients with dacomitinib treatment discontinuation
timeFrame: 30 months from first dose of dacomitinib
measure: Time to dacomitinib treatment discontinuation
timeFrame: 30 months from first dose of dacomitinib
measure: Number of patients with dacomitinib dosage change and reasons
timeFrame: 30 months from first dose of dacomitinib
measure: Time to dacomitinib dosage change
timeFrame: 30 months from first dose of dacomitinib
measure: Concomitant NSCLC-related treatment
timeFrame: 30 months from first dose of dacomitinib
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: