Clinical Trial TitleA phase III, double-blind, placebo controlled, multi-center international study of neoadjuvant/adjuvant durvalumab for the treatment of patients with resectable stages II and III non-small cell lung cancer.
Clinical Trial Protocol Description:
The purpose of this research study is to find out if the drug durvalumab will work and be safe for the treatment of resectable (Stage II and III) non-small cell lung cancer. Durvalumab is still in the development stage and is not yet approved for the treatment of this type of cancer except for use in research studies like this.
Eligible participants will be randomly assigned to 1 of 2 treatment groups: one group will receive durvalumab and chemotherapy and the other group will receive a placebo and chemotherapy prior to resection surgery. Chemotherapy given will be standard of care. After 4 cycles of treatment in either group, participants will have surgery. After surgery, participants will receive the same treatment they received before surgery every 4 weeks for 12 cycles (1 cycle = 28 days). After the final clinic visit (12 months after the final study drug dose), the study staff will contact participants every 3 months until the end of the study to check on their health. The study is planned to go on for about 5 years.
ClinicalTrials.gov Identifier: NCT03800134
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 a diagnosis of NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease.
- Have no prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.
You will be excluded from the study if any of the following criteria apply to you:
- Have had pre-operative radiotherapy treatment as part of your care plan.
- Have a history of allogeneic organ transplantation.
- Have deemed unresectable NSCLC.
This is a partial list of inclusion and exclusion criteria.