A Study to Learn About Dacomitinib in Patients With Non-small Cell Lung Cancer.

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06321510
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer.

This study is seeking participants who:

* have lung cancer that could not be controlled.

* 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 received dacomitinib for their lung cancer.

All participants in this study had received dacomitinib. Dacomitinib is a tablet that is taken by mouth at home. They continued to take dacomitnib until their cancer was 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: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Study Start: 2024-07-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

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

Inclusion Criteria

• Evidence of histologically or cytologically confirmed diagnosis of advanced NSCLC with EGFR-activating mutations detected by an appropriate test
• Patients who were treated with dacomitinib as first-line treatment for advanced NSCLC during 01 October 2020 to 31 December 2022.
• Age ≥18 years old
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria

• Patients who have been treated with any systemic anti-cancer therapies within 12 months prior to dacomitinib treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with dacomitinib treatment discontinuation	52 months from index date	The percentage of patients with dacomitinib treatment discontinuation for any reason during follow-up period will be summarized.
Percentage of patients with dacomitinib dosage change and reasons	52 months from index date	The percentage of patients with dacomitinib dosage change and reason during follow-up period will be summarized.

Secondary Outcome Measures

Name	Time	Method
Real-world overall survival (rwOS)	52 months from index date	Time to death from index date during follow-up period will be summarized by K-M plot with corresponding 95% CI.
Real-world best objective response rate (rwORR)	52 months from index date	Number and percentage of patients achieving real-worl overall response (CR or PR).
Real-world progression-free survival	52 month from index date	Time to real-world disease progression or death, which ever occurs first, during follow-up period will be summarized by K-M plot with corrsponding 95% CI.
real-world intracranial response rate (rwIC-ORR)	52 months from index date	The percentage of patients achieving real-world intracranial response (CR or PR) for brain metastases during follow-up period will be summarized.
real-world extracranial response rate (rwEC-ORR)	52 months from index date	The percentage of patients achieving real-world extracranial response (CR or PR) for brain metastases during follow-up period will be summarized.

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan