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Durvalumab vs Placebo With Stereotactic Body Radiation Therapy 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

Cancer Type
Lung Cancer
Trial Phase
Phase III
18 - 130 Years, Male and Female
Study Type
Protocol IDs
D9103C00001 (primary)
Study Sponsor
AstraZeneca Pharmaceuticals LP


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)

An additional cohort will assess Osimertinib following SBRT in patients with early stage
unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.


Patients who are to receive SoC SBRT as definitive treatment of Stage I/II lymph
node-negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1
to Durvalumab or placebo.

The primary objective of main cohort is to assess the efficacy of Durvalumab with SoC
SBRT compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the
efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of
Overall Survival (OS).

In addition, a study cohort with a sufficient number of patients harboring an EGFR
mutation, will receive Osimertinib treatment after completion of SoC SBRT as definitive
treatment of Stage I/II lymph node-negative NSCLC. The primary objective of Osimertinib
cohort is to assess efficacy of Osimertinib following SoC SBRT in terms of 4years-PFS.
Key secondary objectives include safety, OS and efficacy of Osimertininb treatment with


  1. Age =18 years
  2. Planned SoC SBRT as definitive treatment
  3. 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

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta

3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005

Atlanta Cancer Care - Conyers

1498 Klondike Road
Suite 106
Conyers, GA 30094

Atlanta Cancer Care - Cumming

1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041

Atlanta Cancer Care - Decatur

2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033

Atlanta Cancer Care - Stockbridge

7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069

Atlanta Cancer Care - Tower

5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342

Atlanta Gynecologic Oncology

980 Johnson Ferry Road
Suite 900
Atlanta, GA 30342

Georgia Cancer Specialists - Athens

125 King Avenue
Suite 200
Athens, GA 30606

Georgia Cancer Specialists - Canton

228 Riverstone Drive
Canton, GA 30114

Georgia Cancer Specialists - CenterPointe

1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242

Georgia Cancer Specialists - Kennestone

790 Church Street
Suite 335
Marietta, GA 30060

Georgia Cancer Specialists - Macon-Coliseum

308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152

Georgia Cancer Specialists - Stemmer

2712 Lawrenceville Highway
Decatur, GA 30033

Georgia Gynecologic Oncology

980 Johnson Ferry Road
Suite 910
Atlanta, GA 30342

Northside Hospital Cancer Institute

1000 Johnson Ferry Road NE
Atlanta, GA 30342

Northside Hospital Cancer Institute - Forsyth

1200 Northside Forsyth Drive
Suite 140
Cumming, GA 30041

University Gynecologic Oncology

960 Johnson Ferry Road
Suite 130
Atlanta, GA 30342

**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.