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

Withdrawn

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: dacomitnib

• Registration Number: NCT06075615
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Study Start: 2024-09-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-09-07
• Study Completion: 2026-09-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dacomitnib	dacomitnib	-

Primary Outcome Measures

Name	Time	Method
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 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 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.
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 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 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 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.

Secondary Outcome Measures

Name	Time	Method
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.
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.