A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT05120349
Trial Phases:	Phase III	Protocol IDs:	D516FC00001 (primary) NCI-2022-03173
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT05120349

Summary

This is a global study to assess the effects of osimertinib in participants with EGFRm stage
IA2-IA3 non-small cell lung cancer following complete tumour resection.

Objectives

This is a Phase III, double-blind, randomised, placebo-controlled, 2-arm, international study
assessing the efficacy and safety of adjuvant osimertinib versus placebo in participants with
stage IA2-IA3 EGFRm Non-Small Cell Lung Cancer, who have previously undergone complete tumour
resection. All participants must have had a tumour which harbours one of the 2 common EGFR
mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).

Eligible participants will be randomised in a 1:1 ratio to one of the 2 intervention arms:
osimertinib 80 mg or matching placebo, once daily for 3 years unless discontinuation criteria
is met.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**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.