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Be Part of Research - Trial Details - 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
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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

Not Recruiting

Open to: ALL

Age: 18.0 - 130.0

Manchester London Birmingham Leeds

Medical Conditions

Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2019 Apr 2027

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Durvalumab 1500 mg every 4 weeks \[q4w\] intravenously \[iv\] for up to 26 cycles or until progression or other discontinuation criteria are met.

Intervention Arm Group : SoC SBRT + Durvalumab Therapy (Main Cohort);

Intervention Type : OTHER
Intervention Description : Matching placebo for infusion every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.

Intervention Arm Group : SoC SBRT + Placebo Therapy (Main Cohort);

Intervention Type : DRUG
Intervention Description : 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

Intervention Arm Group : SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Research Site
    Manchester
    M20 4BX
  • Research Site
    London
    EC1A 7BE
  • Research Site
    Birmingham
    B9 5SS
  • Research Site
    Leeds
    LS9 7TF


The study is sponsored by AstraZeneca



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Read full details for Trial ID: NCT03833154
Last updated 08 April 2025

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