NCT07889232Not yet recruitingPhase 1/2
Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 18 Sept 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Lung cancer
- NCT number
- NCT07889232
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 43
- From 1 Nov 2026 to the primary completion date, 30 Apr 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic therapy for metastatic disease
Other illness
- Autoimmune disease requiring immunosuppression
- Active infection or high Gastrointestinal (GI) perforation risk
- Active hepatitis B infection
- Active or untreated latent Tuberculosis (TB) infection
Other
- Symptomatic brain metastasis
Who the study is looking for
- Age ≥ 18 years at the time of consent
- Histologically confirmed metastatic Non-Small Cell Lung Cancer (NSCLC)
- No Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), ROS Proto-Oncogene 1 (ROS1), or Rearranged During Transfection Proto-Oncogene (RET) mutations
- ≥ 5% unintentional weight loss or \>2% if Body Mass Index (BMI) \< 20 kilograms/square meter (kg/m2) in prior 6 months
- Candidate for platinum-doublet and Programmed Death-Ligand 1 (PD-L1) inhibitor
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Baseline Interleukin-6 (IL-6) and C-reactive protein (CRP) available
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Louis Stokes VA Medical Center, Cleveland, OH Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Richard L. Roudebush VA Medical Center, Indianapolis, IN Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.