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Monoclonal Antibodies

Tocilizumab + Atezolizumab for Non-Small Cell Lung Cancer

Phase 1 & 2
Recruiting
Led By Melina Marmarelis, MD, MSCE
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG PS 0-2
Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1st dose of treatment until 1st radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if no progression date registered, assessed up to 24 months.
Awards & highlights

Study Summary

This trial is testing a new combination therapy to see if it is effective and safe in treating non-small cell lung cancer.

Who is the study for?
Adults over 18 with advanced non-squamous Non-Small Cell Lung Cancer (Stage IV or recurrent) who've had at least one prior therapy and were treated with a checkpoint inhibitor right before joining. They should be relatively fit (ECOG PS 0-2). Those with autoimmune diseases, severe past immunotherapy side effects, certain genetic mutations, brain metastases, another active cancer, or uncontrolled cancer pain can't join.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Tocilizumab and Atezolizumab for treating lung cancer that hasn't responded to first-line immune therapies. It aims to assess how safe and effective this drug duo is in managing the disease.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in various organs, fatigue, possible worsening of pre-existing conditions like autoimmune diseases if not excluded from participation, and other common chemotherapy-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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I am 18 or older with advanced non-squamous NSCLC.
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I have undergone at least one treatment for my condition.
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I was treated with a checkpoint inhibitor before joining this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1st dose of treatment until 1st radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if no progression date registered, assessed up to 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 1st dose of treatment until 1st radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if no progression date registered, assessed up to 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Dose Limiting Toxicities of the combination
Overall survival (OS)
Progression free survival (PFS).
Other outcome measures
Clinical outcomes

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474
11%
Low ANC
5%
nausea
5%
Inpatient admission
5%
fatigue
5%
agranulocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tocilizumab
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Atezolizumab and TocilizumabExperimental Treatment2 Interventions
Participants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~6040
Tocilizumab
2012
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,067 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
385 Previous Clinical Trials
144,873 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,713 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04691817 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Atezolizumab and Tocilizumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04691817 — Phase 1 & 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04691817 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you tell me if there is a history of Tocilizumab being used in other medical research studies?

"417 different clinical trials are currently underway to study Tocilizumab with 80 of them in Phase 3. The majority of research is being conducted out of Villejuif, Michigan; however, there are 2310 locations running studies for Tocilizumab."

Answered by AI

Are there any current openings for volunteers in this trial?

"Unfortunately, this study is not currently enrolling patients. However, there are over 2000 other trials for cancer and Tocilizumab that are actively recruiting participants."

Answered by AI

What are the conditions that Tocilizumab is used to manage?

"Tocilizumab is often used to treat small cell lung cancer (sclc), however it can also be taken as a prophylactic for other conditions like systemic juvenile idiopathic arthritis (sjia) and cytokine release syndrome caused by car-t cell therapy."

Answered by AI

What makes this clinical trial different from others?

"Tocilizumab has been the focus of medical research for over a decade. The first trial was sponsored by Hoffmann-La Roche and took place in 2008. After this initial study, which recruited 720 patients, Tocilizumab received approval to enter Phase 2 clinical trials. In total, there are 417 ongoing studies involving Tocilizumab taking place in cities across 81 countries."

Answered by AI

How many patients are taking part in this clinical trial?

"Unfortunately, this clinical trial is not currently looking for new patients. The study was originally posted on 1/1/2023 but was last edited on 7/18/2022. However, there are 2098 other trials actively enrolling patients with carcinoma and 417 trials involving Tocilizumab that are still recruiting participants."

Answered by AI
~19 spots leftby Dec 2025