Clinical Trial TitlePhase II study of consolidation immunotherapy with nivolumab and ipilimumab or nivolumab alone following concurrent chemoradiotherapy for unresectable stage IIIA/IIIB non-small cell lung cancer (NSCLC).
Clinical Trial Protocol Description:
This is an open label, multi-institutional, randomized, phase II trial of treatment with either nivolumab plus ipilimumab or nivolumab alone following treatment with chemoradiation in patients with inoperable or unresectable (not able to be treated with surgery) non-small cell lung cancer. The goal of this study is to learn more about the two approaches to treatment, and to see if they help patients to improve their survival after being diagnosed with this disease.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age at enrollment.
- Have a diagnosis of unresectable or inoperable stage IIIA or IIIB non-small cell lung cancer.
- Have completed concurrent chemoradiation with a platinum doublet and have stable disease or response OR have completed up to 2 cycles of consolidation therapy started within 4-8 weeks of completion of radiation and have a stable disease or response.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than standard concurrent chemoradiation or up to 2 cycles of consolidation as described above.
- Have presence of metastatic disease.
- Have had prior therapy with a PD-1, PD-L1, PD-L2 or CTLA-4 inhibitor or a lung cancer-specific vaccine therapy.
This is a partial list of inclusion and exclusion criteria.