Radiation With or Without Immunotherapy for Early-Stage (Stage I or II) Inoperable Lung Cancer
Clinical Trial: Lung Cancer
Combining Immunotherapy with Stereotactic Body Radiation Therapy (SBRT) in Early-Stage (Stage I or II), Inoperable Lung Cancer
Technical Title: Randomized, Phase I/II Study of Ablative Radiotherapy +/- MEDI 4736 (Durvalumab) for Medically Inoperable Early-Stage Non-Small Cell Lung Cancer
Early-stage (Stage I or II) lung cancer is generally treated with surgery. However, many patients are not good candidates for surgery due to other medical conditions. For these patients, stereotactic body radiation therapy (SBRT) is the standard treatment. While both surgery and SBRT are effective for treating the primary tumor, recurrence of cancer elsewhere in the body, remains a challenge.
This study is being conducted in two parts. The first part will enroll up to 15 patients, and examines whether combining SBRT with Durvalumab, an immunotherapy drug, is safe. Immunotherapy works with the body’s immune system to treat cancer throughout the body. Durvalumab is already FDA approved for treatment of patients with certain bladder cancers and early clinical trials show promise for the treatment of non-small cell lung cancer. The second phase of the study, which will enroll about 90 additional patients, will determine if radiation therapy alone, or radiation therapy combined with Durvalumab, is an effective treatment. The patients who enroll in the second phase of the study will have a 50/50 chance of receiving either SBRT alone, or SBRT and Durvalumab.
In Part 1, all patients will receive SBRT, and receive five separate infusions of Durvalumab over a five month period.
In Part 2, patients will receive either SBRT alone, or SBRT and five separate infusions of Durvalumab over a five month period.
Numerous routine and research-related blood draws will occur throughout course of the study, as well as numerous routine scans. Patients will be asked to return for regular follow-up visits to the UCLA Department of Radiation Oncology at routine intervals for up to five years.
Eligibility Criteria (Basic):
- Must have inoperable, early-stage (Stage I or II) lung cancer
- Must not be eligible for surgery or routine chemotherapy
- May not have had previous treatment
Other eligibility criteria exist.
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