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Trial Title:
A Study to Learn About Dacomitnib in Patients With Non-small Cell Lung Cancer Which Has Spread to the Brain.
NCT ID:
NCT06075615
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Dacomitinib, Non-Small Cell Lung Cancer, Brain Metastasis
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
dacomitnib
Description:
patients with dacomitnib as first line treatment for advanced NSCLC with brain metastasis
Arm group label:
dacomitnib
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.
Criteria for eligibility:
Study pop:
Adults with epidermoid growth factor receport (EGFR)-positive non-small cell lung cancer
(NSCLC) with brain metastasis
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 1, 2024
Completion date:
September 7, 2026
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06075615
