GA NCORP

NCORP Trials

Durvalumab vs Placebo With Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer Patients

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase III
Eligibility
18 - 130 Years, Male and Female
Study Type
Treatment
NCD ID
NCT03833154
Protocol IDs
D9103C00001 (primary)
NCI-2019-02609
2018-002572-41
Study Sponsor
AstraZeneca Pharmaceuticals LP

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.

Objectives

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 this study 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 OS.

Treatment Sites


Atlanta Cancer Care - Alpharetta
3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005
Kristin Sieverding
770-777-1315
www.atlantacancercare.com

Atlanta Cancer Care - Conyers
1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Cumming
1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
Renee Gaiter
770-205-5292 x1041
www.atlantacancercare.com

Atlanta Cancer Care - Decatur
2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Stockbridge
7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
Andrena Jefferson
678 466-2069
www.atlantacancercare.com

Atlanta Cancer Care - Tower
5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342
404-303-3355
www.atlantacancercare.com

Atlanta Gynecologic Oncology
980 Johnson Ferry Road
Suite 900
Atlanta, GA 30342
Jen Cuvo
404-303-3355
www.geraldfeuer.com

Georgia Cancer Specialists - Athens
125 King Avenue
Suite 200
Athens, GA 30606
Cynthia Pirkle
www.gacancer.com

Georgia Cancer Specialists - Canton
228 Riverstone Drive
Canton, GA 30114
www.gacancer.com

Georgia Cancer Specialists - CenterPointe
1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
Anila Lokhandwala
404-256-4777 ext 9242
www.gacancer.com

Georgia Cancer Specialists - Kennestone
790 Church Street
Suite 335
Marietta, GA 30060
Greta Dudley
www.gacancer.com

Georgia Cancer Specialists - Macon-Coliseum
308 Coliseum Drive
Suite 120
Macon, GA 31217
Sonia Hernandez
478-745-6130 x8152
www.gacancer.com

Georgia Cancer Specialists - Stemmer
2712 Lawrenceville Highway
Decatur, GA 30033
Nina Patel
770-496-5555
www.gacancer.com

Georgia Gynecologic Oncology
980 Johnson Ferry Road
Suite 910
Atlanta, GA 30342
Jen Cuvo
404-303-3355
www.ggo-atl.com/

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
Northside Hospital Central Research Department
404-303-3355
www.northside.com

Northside Hospital Cancer Institute - Forsyth
1200 Northside Forsyth Drive
Suite 140
Cumming, GA 30041
404-303-3355
www.northside.com

University Gynecologic Oncology
960 Johnson Ferry Road
Suite 130
Atlanta, GA 30342
Jen Cuvo
404-303-3355
www.ugynonc.com