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Metastatic Non-Small Cell Lung CancerWeight managementCancerDrugPhase 1, Phase 2

What this study is

Simplified from ClinicalTrials.gov

Testing a drug added to standard chemotherapy and immunotherapy (tocilizumab) to see if it is safe and works against metastatic non-small cell lung cancer, meaning lung cancer that has spread, in adults 18 or older starting first-line treatment who have lost significant weight or muscle mass and have high inflammatory markers.

Read the original summary from ClinicalTrials.gov

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.

What's being tested

  • Tocilizumab

    Intervention · DRUG

    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

    Intervention · DRUG

    Pembrolizumab is administered per standard-of-care dosing every 21 days in combination with platinum-based doublet chemotherapy and tocilizumab.

  • Platinum-Doublet Chemotherapy

    Intervention · DRUG

    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.

Study details

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
Sponsor
VA Office of Research and Development
Conditions
Metastatic Non-Small Cell Lung Cancer · Cancer-Associated Weight Loss · Elevated Inflammatory Markers
Enrolling
43 people
Starts
2026-11-01
Est. completion
2029-10-31
Design
Open-label, single group, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗