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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06075615

Enrollment

Registered

2023-10-10

Start date

2024-09-30

Completion date

2026-09-07

Last updated

2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Dacomitinib, Non-Small Cell Lung Cancer, 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.

Interventions

DRUGdacomitnib

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The real-world overall survival (rwOS) during 24 months from index date	24 months from index date	Time to real-world death during 24 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
The real-world systemic overall response rate (rwORR) at Month 3	3 months from first dose of dacomitinib	The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 3 (± 4 weeks) will be summarized.
The real-world systemic overall response rate (rwORR) at Month 6.	6 months from first dose of dacomitinib	The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.
The real-world systemic overall response rate (rwORR) at Month 12.	12 months from first dose of dacomitinib	The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 12 (± 4 weeks) will be summarized.
The real-world progression-free survival (rwPFS) during 12 months from index date	12 months from index date	Time to real-world disease progression or death, whichever occurs first, during 12 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
The real-world overall survival (rwOS) during 12 months from index date	12 months from index date	Time to real-world death during 12 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
The real-world intracranial overall response rate (rwICORR) at Month 3	3 months from first dose of dcomitnib	The percentage of patients achieving real-world intracranial overall response (complete response (CR) or partial response (PR)) for brain metastases at Month 3 (± 4 weeks) will be summarized.
The real-world intracranial overall response rate (rwICORR) at Month 6	6 months from first dose of dacomitnib	The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.
The real-world intracranial overall response rate (rwICORR) at Month 12	12 months from first dose of dacomitinib	The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 12 (± 4 weeks) will be summarized.
The real-world intracranial clinical benefit rate (rwICBR) at Month 3	3 months from first dose of dacomitinib	The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 3 (± 4 weeks) will be summarized
The real-world intracranial clinical benefit rate (rwICBR) at Month 6	6 months from first dose of dacomitinib	The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 6 (± 4 weeks) will be summarized
The real-world intracranial clinical benefit rate (rwICBR) at Month 12	12 months from first dose of dacomitinib	The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 12 (± 4 weeks) will be summarized
The real-world intracranial time to progression (rwICTTP)	30 months from first dose of dacomitinib	The mean and median of the time to the date of the first documentation of real-world progression of intracranial disease.

Secondary

Measure	Time frame	Description
Time to dacomitinib treatment discontinuation	30 months from first dose of dacomitinib	Time to dacomitinib treatment discontinuation during follow-up period will be summarized by the K-M plot with the corresponding 95% CI.
Number of patients with dacomitinib dosage change and reasons	30 months from first dose of dacomitinib	The number of patients with dacomitinib dosage change and reason during follow-up period will be summarized.
Time to dacomitinib dosage change	30 months from first dose of dacomitinib	Time to dacomitinib dosage change during follow-up period will be summarized by the K-M plot with the corresponding 95% CI.
Concomitant NSCLC-related treatment	30 months from first dose of dacomitinib	The number patients with concomitant NSCLC-related treatment will be summarized.
Percentage of patients with dacomitinib treatment discontinuation	30 months from first dose of dacomitinib	The percentage of patients with dacomitinib treatment discontinuation for any reason during follow-up period will be summarized.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026