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Not yet recruitingPhase 1 / Phase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months, 3 months, 12 months
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Clinically, cachexia is defined by the international consensus (Fearon criteria) as weight loss \>5% over 6 months, or weight loss \>2% in individuals with a body mass index (BMI) \< 20 kg/m2 or sarcopenia."
  • "If eligible, participants will attend study treatment visits every 21 days for about 3 months, an End of Treatment (EOT) visit about 30 days after the last dose of treatment, and follow up for up to 12 months after the EOT visit."
  • "Tocilizumab is administered as a single IV drip infusion over 1 hour; it cannot be administered as bolus or push."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (4)

IN

MI

OH

  • Louis Stokes VA Medical Center, Cleveland, OH · Cleveland, OH 44106-1702Margaret Tiktin, DNP · Study contact · (216) 231-3241Charles J Nock, MD · Principal investigatorMore trials in Cleveland

PA