A Study to Learn About Dacomitnib in Patients With Non-small Cell Lung Cancer Which Has Spread to the Brain.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06075615
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Carcinoma, Non-Small-Cell Lung

Arms & Interventions

Arms

: dacomitnib

Interventions

Drug: - dacomitnib

patients with dacomitnib as first line treatment for advanced NSCLC with brain metastasis

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Pfizer CT.gov Call Center

[email protected]

1-800-718-1021

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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