A Phase II Study of Durvalumab Immunotherapy and Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer

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Full Title

Stereotactic Body Radiation Therapy with Consolidation Durvalumab in High-Risk Early-Stage Non-Small Cell Lung Cancer - A Phase II Single-Arm Trial

Purpose

The purpose of this study is to learn whether treatment with the immunotherapy drug durvalumab combined with a type of radiation therapy called stereotactic body radiation (SBRT) is a more effective treatment for inoperable high-risk early-stage non-small cell lung cancer (NSCLC) than SBRT alone. Researchers want to see if adding treatment with durvalumab to SBRT will reduce the chance that a patient’s cancer will get worse. All patients will receive both durvalumab and SBRT.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable stage I-IIIA NSCLC.
  • Patients must have an estimated risk of 40 percent or higher of the cancer getting worse, based on tumor size and activity on a PET scan.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Andreas Rimner at 646-608-2449.

Protocol

20-415

Phase

II

Investigator