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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06075615
• Other study ID #: A7471072
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: September 7, 2026

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 7, 2026
• Est. primary completion date: September 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The real-world intracranial overall response rate (rwICORR) at Month 3	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.	3 months from first dose of dcomitnib
Primary	The real-world intracranial overall response rate (rwICORR) at Month 6	The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.	6 months from first dose of dacomitnib
Primary	The real-world intracranial overall response rate (rwICORR) at Month 12	The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 12 (± 4 weeks) will be summarized.	12 months from first dose of dacomitinib
Primary	The real-world intracranial clinical benefit rate (rwICBR) at Month 3	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	3 months from first dose of dacomitinib
Primary	The real-world intracranial clinical benefit rate (rwICBR) at Month 6	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	6 months from first dose of dacomitinib
Primary	The real-world intracranial clinical benefit rate (rwICBR) at Month 12	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	12 months from first dose of dacomitinib
Primary	The real-world intracranial time to progression (rwICTTP)	The mean and median of the time to the date of the first documentation of real-world progression of intracranial disease.	30 months from first dose of dacomitinib
Primary	The real-world systemic overall response rate (rwORR) at Month 3	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.	3 months from first dose of dacomitinib
Primary	The real-world systemic overall response rate (rwORR) at Month 6.	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.	6 months from first dose of dacomitinib
Primary	The real-world systemic overall response rate (rwORR) at Month 12.	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.	12 months from first dose of dacomitinib
Primary	The real-world progression-free survival (rwPFS) during 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.	12 months from index date
Primary	The real-world overall survival (rwOS) during 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.	12 months from index date
Primary	The real-world overall survival (rwOS) during 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.	24 months from index date
Secondary	Percentage of patients with dacomitinib treatment discontinuation	The percentage of patients with dacomitinib treatment discontinuation for any reason during follow-up period will be summarized.	30 months from first dose of dacomitinib
Secondary	Time to dacomitinib treatment discontinuation	Time to dacomitinib treatment discontinuation during follow-up period will be summarized by the K-M plot with the corresponding 95% CI.	30 months from first dose of dacomitinib
Secondary	Number of patients with dacomitinib dosage change and reasons	The number of patients with dacomitinib dosage change and reason during follow-up period will be summarized.	30 months from first dose of dacomitinib
Secondary	Time to dacomitinib dosage change	Time to dacomitinib dosage change during follow-up period will be summarized by the K-M plot with the corresponding 95% CI.	30 months from first dose of dacomitinib
Secondary	Concomitant NSCLC-related treatment	The number patients with concomitant NSCLC-related treatment will be summarized.	30 months from first dose of dacomitinib