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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTocilizumab and Pembrolizumab

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 22, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Not Yet Recruiting

The study is not accepting participants yet.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?VA Office of Research and Development

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: VA Office of Research and Development
Interventions being studied: Drug: Tocilizumab; Drug: Pembrolizumab; Drug: Platinum-Doublet Chemotherapy

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolis, Indiana
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn Arbor, Michigan
Louis Stokes VA Medical Center, Cleveland, OHCleveland, Ohio
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburgh, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 22, 2026. Always confirm current availability with the study team.

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