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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Dacomitinib

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • University Malaya Medical Centre
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • Pantai Hospital Kuala Lumpur
  • Petaling Jaya, Malaysia, 46050
    • Recruiting
    • Beacon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Tertiary cancer-treating hospitals in China, India and Malaysia are planned as participating sites.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1	Drug: Dacomitinib; This is a non-interventional, real world study of Asian patients being treated with dacomitinib as first-line treatment for EGFR+ NSCLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who initiated dacomitinib at 45mg, 30mg and 15mg dose respectively	Uo to 3 years
Proportion of patients that experience dose modification	Up to 3 years
Proportion of patients that experience dose interruption	Up to 3 years
Proportion of patients that experience dose discontinuation	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall response rate	Up to 3 years
Real world progression-free survival	Up to 3 years

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2021
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: A7471067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No