Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. 3. No prior therapy for advanced NSCLC. 4. Patients with brain metastasis are eligible if they are asymptomatic or treated and stable. 5. Age greater than or equal to 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 7. Life expectancy of greater than 12 weeks. 8. Patients must have adequate organ and marrow function, including: 1. Absolute neutrophil count (ANC) ≥ 1,500/mcL 2. Platelet count ≥ 100,000/mcL 3. Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this) 4. Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum