Clinical Trial TitleA phase II study of concurrent chemoradiation plus durvalumab (MEDI4736) followed by surgery followed by adjuvant durvalumab in medically operable patients with surgically resectable stage III (N2) non-small cell lung cancer.
Clinical Trial Protocol Description:
In this study, eligible patients will get one cycle of treatment that includes a combination of chemotherapy, radiation and durvalumab. If the disease responds and is not progressing (becoming active), they will have surgery to remove the rest of the cancer. Once they recover from surgery, the disease will be evaluated and if the disease is inactive, patients will receive the drug durvalumab for 6 cycles.
This study is being done to find out if chemotherapy, radiation and durvalumab followed by surgical resection (surgery to remove cancerous tumor) is safe and if it will keep the disease away for a longer period of time. The study will also look at whether adding durvalumab after surgical resection will provide a longer period of time that the cancer is inactive.
ClinicalTrials.gov Identifier: NCT03871153
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age at the time of study consent.
- Have resectable and medically operable stage III (N2) NSCLC with biopsy-proven N2 disease.
- Have no distant metastasis, defined as M0 in the TMN staging system.
You will be excluded from the study if any of the following criteria apply to you:
- Have not received any prior therapy for the current diagnosis of NSCLC. Treatments done for previously diagnosed malignancies are permitted. Prior therapy with a PD-1, PD-L1 (including durvalumab), PD-L2 or CTLA-4 inhibitor or a lung cancer-specific vaccine therapy are not permitted.
- Have interstitial lung disease or history of pneumonitis requiring treatment with corticosteroids.
This is a partial list of inclusion and exclusion criteria.