A Study To Compare Durvalumab Vs Placebo Following Stereotactic Body Radiation Therapy In Early Stage Non-small Cell Lung Cancer Patients

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of durvalumab versus placebo following Stereotactic Body Radiation Therapy  (SBRT) in patients with unresected clinical Stage I/II lymph node-negative Non-small Cell Lung Cancer (NSCLC).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • 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.
  • Completion of SoC SBRT as definitive treatment prior to randomization.
  • 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.
  • Tumor sample required.
  • Adequate organ and marrow function required.
  • Patients with central or peripheral lesions are eligible.
  • Staging studies must be done within 8 weeks before randomization.

Exclusion Criteria:

  • Mixed small cell and non-small cell cancer histology.
  • History of allogeneic organ transplantation.
  • History of another primary malignancy with exceptions.
  • History of active primary immunodeficiency.
  • Any unresolved toxicity National Cancer Institute (NCI) CTCAE Grade ≥ 2 from SBRT (Stereotactic Body Radiation Therapy).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Merrell, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions