Real World Utilization and Outcomes With Dacomitinib First Line Treatment for EGFR Mutation-positive Advanced Non Small Cell Lung Cancer Among Asian Patients - A Multi Center Chart Review

Lung Cancer Clinical Trial

Official title:

ARIA: Real-world Utilization and Outcomes With Dacomitinib First-line Treatment for EGFR Mutation-positive Advanced Non-small Cell Lung Cancer Among Asian Patients - A Multi-center Chart Review

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04609319
• Other study ID #: A7471067
• Status: Active, not recruiting
• Start date: January 23, 2021
• Est. completion date: October 8, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a longitudinal, consecutive case-series, multi-center study with mixed prospective and retrospective data collection. Data will be collected from eligible adults with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) treated with dacomitinib as first-line therapy from the date of advanced NSCLC diagnosis to the date of death, lost to follow-up, withdrawal of consent or end of study, whichever occurs first.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 8, 2024
• Est. primary completion date: June 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (aged =18 years) with histology-confirmed advanced NSCLC (TNM stage IIIB-IV);

• Presence of any EGFR-activating mutation (exon 19 deletion or exon 21 L858R substitution) or other uncommon EGFR mutations prior to anti-cancer treatment;

• Initiating dacomitinib as first-line treatment after confirmation of EGFR-mutation status (ie, no prior treatment with other EGFR TKI or systemic therapy);

Exclusion Criteria:

• Enrolled in any interventional clinical study or trial (however, patients enrolled in non-interventional, real world study may still be included).

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Dacomitinib
This is a non-interventional, real world study of Asian patients being treated with dacomitinib as first-line treatment for EGFR+ NSCLC

Locations

Country	Name	City	State
Malaysia	Pantai Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Beacon Hospital	Petaling Jaya

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who initiated dacomitinib at 45mg, 30mg and 15mg dose respectively		Uo to 3 years
Primary	Proportion of patients that experience dose modification		Up to 3 years
Primary	Proportion of patients that experience dose interruption		Up to 3 years
Primary	Proportion of patients that experience dose discontinuation		Up to 3 years
Secondary	Real world progression-free survival		Up to 3 years
Secondary	Overall response rate		Up to 3 years

External Links

•   To obtain contact information for a study center near you, click here.