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

Trial Status: Active

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.

Inclusion Criteria

  • Age ≥18 years
  • Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive treatment with SBRT. Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy
  • Planned SoC SBRT as definitive treatment
  • World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2
  • Life expectancy of at least 12 weeks
  • Body weight >30 kg
  • Submission of available tumor tissue sample
  • Adequate organ and marrow function required
  • Patients with central or peripheral lesions are eligible
  • Staging studies must be done within 10 weeks before randomization
  • Patients with a history of metachronus stage I/II (T1-T3N0M0) NSCLC treated definitively surgery only or SBRT only >1 year prior to enrollment are eligible.

Exclusion Criteria

  • Mixed small cell and non-small cell cancer
  • History of allogeneic organ transplantation
  • History of another primary malignancy with exceptions
  • History of active primary immunodeficiency

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
San Francisco
UCSF Medical Center-Mount Zion
Status: APPROVED
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: ACTIVE

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Rebecca Hudson
Phone: 410-328-4827

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: IN_REVIEW

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: ACTIVE
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: APPROVED
Durham
Duke University Medical Center
Status: ACTIVE
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Caryn R. Weir
Phone: 804-628-2310
Email: cweir@vcu.edu

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D9103C00001
  • Secondary IDs NCI-2019-02609, 2018-002572-41
  • Clinicaltrials.gov ID NCT03833154