This early phase 1 trial will investigate the combination of low-dose interleukin-2 (IL-2) and pembrolizumab in patients with previously untreated stage IV non-small cell lung cancer (NSCLC). Preclinical data demonstrate reinvigoration of exhausted T cells into an effector-like phenotype with improved anti-tumor activity in response to this combination. This study will evaluate T cell function as well as clinical outcomes associated with this combination therapy.
Patients must have Stage IV non-small cell lung cancer (NSCLC), based on the 8th edition of the American Joint Committee on Cancer (AJCC) NSCLC Staging System. This includes adenocarcinoma and squamous cell carcinoma.
Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
No prior therapy for advanced NSCLC.
Patients with brain metastasis are eligible if they are asymptomatic or treated and stable.
Any prior chemotherapy or immunotherapy for advanced lung cancer.
Prior treatment with anti-PD-1 or anti-PD-L1 therapies or pathway-targeting agents.
Any targetable driver mutation (e.g. ALK, EGFR exon 19 del, etc).
Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator