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Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer
Sponsor: VA Office of Research and Development
Summary
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.
Official title: A Phase 1b Study of Tocilizumab Combined With Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer Patients With Cancer-Associated Weight Loss and Elevated Inflammatory Markers. The TOCI Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
43
Start Date
2026-11-01
Completion Date
2029-10-31
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Tocilizumab
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
Pembrolizumab is administered per standard-of-care dosing every 21 days in combination with platinum-based doublet chemotherapy and tocilizumab.
Platinum-Doublet Chemotherapy
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.
Locations (4)
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States