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Clinical Trials in the USA / NCT03833154
Active, not recruiting Phase 3

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

NCT03833154 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2019-03-06
Last updated
2026-07-20

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

DurvalumabPlacebo(Osimertinib cohort, single-arm, open-label separate cohort)

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

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Main Cohort Key Inclusion Criteria: 1. Age ≥18 years 2. Planned SoC SBRT as definitive treatment 3. World Health Organization (WHO)/ECOG PS of 0, 1 or 2 4. Life expectancy of at least 12 weeks 5. Body weight \>30 kg 6. Submission of tumor tissue sample if available 7. Adequate organ and marrow function required 8. Patients with central or peripheral lesions are eligible 9. Staging studies must be done during screening (PET-CT within 10 weeks) 10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions Main Cohort Key Exclusion Criteria: 1. Mixed small cell and non-small cell cancer 2. History of allogeneic organ transplantation 3. History of another primary malignancy with exceptions 4. History of active primary immunodeficiency 5. Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort 6. Prior exposure to immune-mediated therapy with exceptions Osimertinib Cohort Key Inclusion Criteria 1. Age ≥18 years 2. Planned SoC SBRT as definitive treatment 3. WHO/ECOG PS of 0, 1, or 2 4. Patients with central or peripheral lesions are eligible 5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions 6. Staging studies must be done during screening (PET-CT within 10 weeks) 7. Submission of tumor tissue sample if available 8. Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R) 9. Adequate bone marrow reserve or organ function required 10. Female patients should be using highly effective contraceptive measures 11. Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation Osimertinib Cohort Key Exclusion Criteria 1. Mixed small cell and non-small cell cancer 2. Patients with known or increased risk factor for QTc prolongation 3. Treatment with any of the following: * Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation * Prior treatment with neoadjuvant or adjuvant EGFR TKI * Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 4. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib 5. Any of the following cardiac criteria * Mean resting corrected QT interval \>470 msec, obtained from 3 ECGs * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval * Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

Primary outcome measure(s)

Trial sites (209)

FacilityCityRegionStatus
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 the USA

Other trials for the same condition

Official registry record

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 the USA