VA Office of Research and Development
This is a Phase 1b/2, multi-site, single-arm, open-label, non-randomized study looking at whether adding tocilizumab to standard treatment for metastatic Non-Small Cell Lung Cancer (NSCLC) is safe, possible, and effective. The study includes people with metastatic NSCLC, that is lung cancer that has spread, who have experienced significant loss of weight or muscle mass.
Lung cancer remains the leading cause of cancer-related mortality globally, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of all diagnoses. For patients with metastatic NSCLC lacking actionable driver mutations (e.g., EGFR, ALK), the standard first-line therapeutic strategy involves immune checkpoint inhibitors (ICIs) targeting the programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) axis, administered either as monotherapy or in combination with platinum-doublet chemotherapy. While these regimens have significantly improved overall survival (O…
Inclusion Criteria: 1. Age ≥ 18 years at the time of consent 2. Histologically confirmed metastatic Non-Small Cell Lung Cancer (NSCLC) 3. No Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), ROS Proto-Oncogene 1 (ROS1), or Rearranged During Transfection Proto-Oncogene (RET) mutations 4. ≥ 5% unintentional weight loss or \>2% if Body Mass Index (BMI) \< 20 kilograms/square meter (kg/m2) in prior 6 months 5. Candidate for platinum-doublet and Programmed Death-Ligand 1 (PD-L1) inhibitor 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 7. Measurable dis…
Tocilizumab 8 mg/kg intravenous infusion administered once every 21 days (Day 1 of each cycle) for up to 4 doses. The drug is diluted in 0.9% or 0.45% sodium chloride and infused over 60 minutes. Tocilizumab is given in combination with pembrolizumab and platinum-based doublet chemotherapy. Dose reductions to 4 mg/kg are permitted per protocol in the setting of toxicity.
Pembrolizumab is administered per standard-of-care dosing every 21 days in combination with platinum-based doublet chemotherapy and tocilizumab.
Standard-of-care platinum doublet chemotherapy administered every 21 days in combination with pembrolizumab and tocilizumab, using either carboplatin with pemetrexed (non-squamous NSCLC) or carboplatin with a taxane (squamous NSCLC), per institutional guidelines.