Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients

Active:	Yes
Cancer Type:	Lung Cancer Unknown Primary	NCT ID:	NCT06538038
Trial Phases:		Protocol IDs:	PrE1702 (primary) NCI-2024-10275
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	PrECOG, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT06538038

Summary

The goal of the study is to collect data on patients treated outside of a clinical trial
(in routine clinical practice) with standard of care osimertinib with or without
chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer
(NSCLC) to better understand the safety and effectiveness of these standard of care
regimens.

Objectives

This study tests the feasibility of using real-world data collection through the
recruitment of well-characterized patients into a registry, spanning academic and
community practice sites to determine patient outcomes in all-comers. The scientific
community would further benefit from a greater understanding of the safety and
effectiveness of newly approved therapies prescribed in routine clinical practice.

Non-interventional (observational) study with 250 participants per exposure group
(maximum accrual up to 538 total participants) comparing outcomes in patients with
EGFR-mutated NSCLC, not being treated in a clinical trial but receiving standard of care
osimertinib +/- chemotherapy.

The treating physician determines whether a patient will receive standard of care single
agent osimertinib or osimertinib with chemotherapy and the planned treatment is recorded
at registration.

Clinical/Imaging assessments will be per the treating physician.

Treatment Sites in Georgia

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

Doctors:

Mark A. Taylor MD

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.