Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer

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.

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 disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 8. Baseline Interleukin-6 (IL-6) and C-reactive protein (CRP) available Exclusion Criteria: 1. Prior systemic therapy for metastatic disease 2. Autoimmune disease requiring immunosuppression 3. Active infection or high Gastrointestinal (GI) perforation risk 4. Symptomatic brain metastasis 5. Active hepatitis B infection 6. Active or untreated latent Tuberculosis (TB) infection