Tocilizumab + Chemo-Immunotherapy for Non-Small Cell Lung Cancer

(TOCI Trial)

Not yet recruiting at 3 trial locations
CJ
Overseen ByCharles J Nock, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: VA Office of Research and Development
Must be taking: Platinum-doublet, PD-L1 inhibitor
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding tocilizumab, an immunotherapy, to standard treatments for advanced lung cancer is safe and effective. The focus is on individuals with Non-Small Cell Lung Cancer (NSCLC) that has spread and who have lost weight or muscle mass. Participants should have experienced recent unintentional weight loss and be suitable for specific cancer treatments. The goal is to determine if this new combination can improve treatment outcomes for these patients. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining pembrolizumab with platinum-based chemotherapy is generally well-tolerated by patients with non-small cell lung cancer (NSCLC). Studies have found that about 46.4% of patients experienced serious side effects, similar to other cancer treatments. Despite these side effects, this treatment has been linked to better survival rates.

Tocilizumab, which is being added to this treatment, is already approved for conditions like rheumatoid arthritis, indicating a known safety profile. However, its use in cancer treatment remains under investigation. As this trial is in its early stages, researchers are closely monitoring safety and patient tolerance.

Prospective participants should discuss potential risks and benefits with the study team and their healthcare provider.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about the combination of Tocilizumab with chemo-immunotherapy for non-small cell lung cancer because it introduces a novel approach to treatment. Unlike standard treatments like pembrolizumab or platinum-based chemotherapy alone, this combination adds Tocilizumab, which targets the interleukin-6 (IL-6) pathway. By inhibiting IL-6, Tocilizumab may reduce inflammation and enhance the effectiveness of the immune response against cancer cells. This innovative mechanism could potentially improve outcomes for patients who do not respond fully to existing therapies.

What evidence suggests that this trial's treatments could be effective for metastatic Non-Small Cell Lung Cancer?

Studies have shown that combining pembrolizumab with platinum-based chemotherapy can extend the lives of lung cancer patients. Specifically, patients receiving this combination often experience longer periods without cancer progression and generally live longer than those not receiving pembrolizumab. Research suggests that adding pembrolizumab to standard treatments offers significant long-term benefits. In this trial, Tocilizumab is added to the treatment mix. Known for reducing inflammation, Tocilizumab is being tested to determine if it can enhance the effects of the other treatments. Early signs indicate that this combination might more effectively manage advanced lung cancer.678910

Who Is on the Research Team?

CJ

Charles J Nock, MD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

This trial is for adults with metastatic non-small cell lung cancer (NSCLC) whose cancer has spread and who have lost a significant amount of weight or muscle. Participants should be able to safely receive chemo-immunotherapy.

Inclusion Criteria

I have been diagnosed with metastatic non-small cell lung cancer.
≥ 5% unintentional weight loss or >2% if BMI < 20 kg/m2 in prior 6 months
Baseline IL-6 and CRP available
See 5 more

Exclusion Criteria

I currently have an active hepatitis B infection.
I have received drug treatment for cancer that has spread.
I have symptoms from cancer that has spread to my brain.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tocilizumab in addition to standard chemo-immunotherapy for metastatic NSCLC, with visits every 21 days for about 3 months

12 weeks
4 visits (in-person)

End of Treatment

End of Treatment visit occurs approximately 30 days after the last dose of treatment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment for up to 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • Platinum-Doublet Chemotherapy
  • Tocilizumab

Trial Overview

The study tests if adding tocilizumab to standard first-line treatment—pembrolizumab plus platinum-based chemotherapy—is safe and effective for people with advanced NSCLC. All participants receive the same combination.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Indiana University

Collaborator

Trials
1,063
Recruited
1,182,000+

Citations

Platinum Doublet Chemotherapy plus Pembrolizumab for ...

In summary, pembrolizumab plus EP significantly improved PFS compared with placebo plus EP as first-line therapy for patients with extensive-stage SCLC. No ...

Immunotherapy and non-small cell lung cancer - AboutScience

demonstrated improved overall survival (OS) ORRs appeared 26% compared to 34% with platinum-doublet chemotherapy.

Treatment Patterns and Outcomes of Non-Small Cell ...

Of 311 patients, 178 received ICI monotherapy and 133 received CIT. Adjusted median rwTTNT was 11.31 months for the CIT group compared to 7.63 for the ICI group ...

KEYNOTE Trial Data: Pembrolizumab's Role in NSCLC

The big dramatic benefit with pembrolizumab monotherapy was in the 50% or higher subset, and it diluted progressively as you added the patients with a 20% ...

Five-Year Outcomes With Pembrolizumab Versus ...

CONCLUSION Pembrolizumab provides a durable, clinically meaningful long-term OS benefit versus chemo- therapy as first-line therapy for ...

KEYNOTE Trial Data: Pembrolizumab's Role in NSCLC

with pembrolizumab monotherapy was in the 50% In fact, the hazard ratio was 0.92. as well in efficacy and had a better tolerability with pembrolizumab.

Spotlight on pembrolizumab in non-small cell lung cancer

This Phase I/II trial with eight cohorts aims to study the safety, tolerability, and efficacy of pembrolizumab in combination with other therapies in treatment- ...

Pembrolizumab vs Topotecan in Patients With Small Cell ...

This is a multi-institutional, randomized, open-label phase II study of pembrolizumab compared to topotecan, administered to patients with SCLC

Study Details | NCT04324151 | Pembrolizumab Combined ...

This study aims to explore the efficacy and safety of Pembrolizumab Combined With Double Platinum-Based Chemotherapy for Potentially Resectable Non-driver

Five-Year Outcomes With Pembrolizumab Versus ...

pembrolizumab, 82.1% of whom were still alive at data cutoff (approximately 5 years). Toxicity did not increase with longer treatment exposure.