Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation
Condition(s) studied
Investigational drug(s) / intervention(s)
Durvalumab: Durvalumab 1500 mg every 4 weeks \[q4w\] intravenously \[iv\] for up to 26 cycles or until progression or other discontinuation criteria are met.
Placebo: Matching placebo for infusion every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.
(Osimertinib cohort, single-arm, open-label separate cohort): Osimertinib 80 mg every day \[qd\] orally for up to 36 months or until progression or other discontinuation criteria are met. Osimertinib treatment should start from 7 to 14 days after completion of SBRT
Study summary
This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.
An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC — from randomization up to 6 years
Main Cohort - 4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria — from treatment start up to 5 years
Osimertinib Cohort
Trial sites (209)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Tuscaloosa | Alabama | |
| Research Site | Chandler | Arizona | |
| Research Site | Phoenix | Arizona | |
| Research Site | Tucson | Arizona | |
| Research Site | Duarte | California | |
| Research Site | Long Beach | California | |
| Research Site | Los Angeles | California | |
| Research Site | San Diego | California | |
| Research Site | Newark | Delaware | |
| Research Site | Washington D.C. | District of Columbia | |
| Research Site | Bay Pines | Florida | |
| Research Site | Jacksonville | Florida | |
| Research Site | Miami Beach | Florida | |
| Research Site | Orlando | Florida | |
| Research Site | Atlanta | Georgia | |
| Research Site | Atlanta | Georgia | |
| Research Site | Chicago | Illinois | |
| Research Site | Chicago | Illinois | |
| Research Site | Chicago | Illinois | |
| Research Site | Decatur | Illinois | |
| Research Site | Elmhurst | Illinois | |
| Research Site | Naperville | Illinois | |
| Research Site | Fort Wayne | Indiana | |
| Research Site | Cedar Rapids | Iowa | |
| Research Site | Iowa City | Iowa | |
| Research Site | Elizabethtown | Kentucky | |
| Research Site | Lexington | Kentucky | |
| Research Site | Louisville | Kentucky | |
| Research Site | Metairie | Louisiana | |
| Research Site | New Orleans | Louisiana | |
| Research Site | South Portland | Maine | |
| Research Site | Annapolis | Maryland | |
| Research Site | Baltimore | Maryland | |
| Research Site | Rosedale | Maryland | |
| Research Site | Silver Spring | Maryland | |
| Research Site | Towson | Maryland | |
| Research Site | Boston | Massachusetts | |
| Research Site | Ann Arbor | Michigan | |
| Research Site | Detroit | Michigan | |
| Research Site | Royal Oak | Michigan |
+ 169 more sites — see the full list on the official registry below.
On this site
📄 Imfinzi (durvalumab) drug profile →More AstraZeneca trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03833154 on ClinicalTrials.gov ↗ ← All trials in South Korea