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

Lung Cancer Clinical Trial

Official title:

Real-World Treatment Patterns and Clinical Effectiveness of Dacomitinib in Advanced Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor-Positive in Taiwan

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06321510
• Other study ID #: A7471070
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: March 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with dacomitinib dosage change and reasons	The percentage of patients with dacomitinib dosage change and reason during follow-up period will be summarized.	52 months from index date
Primary	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.	52 months from index date
Secondary	Real-world overall survival (rwOS)	Time to death from index date during follow-up period will be summarized by K-M plot with corresponding 95% CI.	52 months from index date
Secondary	Real-world progression-free survival	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.	52 month from index date
Secondary	Real-world best objective response rate (rwORR)	Number and percentage of patients achieving real-worl overall response (CR or PR).	52 months from index date
Secondary	real-world intracranial response rate (rwIC-ORR)	The percentage of patients achieving real-world intracranial response (CR or PR) for brain metastases during follow-up period will be summarized.	52 months from index date
Secondary	real-world extracranial response rate (rwEC-ORR)	The percentage of patients achieving real-world extracranial response (CR or PR) for brain metastases during follow-up period will be summarized.	52 months from index date