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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
Must not have
Presence of a driver mutation that is susceptible to targeted therapy
Uncontrolled tumor related pain
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
No Placebo-Only Group
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.
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.
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 belowSelect...
I can take care of myself and perform daily activities.
Select...
I am 18 or older with advanced non-squamous NSCLC.
Select...
I have undergone at least one treatment for my condition.
Select...
I was treated with a checkpoint inhibitor before joining this trial.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has a mutation that can be treated with targeted therapy.
Select...
I have pain from my cancer that isn't relieved by treatment.
Select...
I haven't had severe side effects from previous immunotherapy.
Select...
My cancer has spread to my brain and is getting worse or hasn't been treated.
Select...
I have or had cancer spread to the lining of my brain and spinal cord.
Select...
I have a history of an autoimmune disease or idiopathic pulmonary fibrosis.
Select...
I am currently being treated for another type of cancer.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate (ORR)
Secondary study objectives
Dose Limiting Toxicities of the combination
Overall survival (OS)
Progression free survival (PFS).
Other study objectives
Clinical outcomes
Side effects data
From 2017 Phase 4 trial • 59 Patients • NCT0203447411%
Low ANC
5%
nausea
5%
agranulocytosis
5%
Inpatient admission
5%
fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tocilizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~5860
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
108,327 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
418 Previous Clinical Trials
463,800 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,972 Total Patients Enrolled
Melina Marmarelis, MD, MSCEPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has a mutation that can be treated with targeted therapy.I have pain from my cancer that isn't relieved by treatment.I can take care of myself and perform daily activities.I haven't had severe side effects from previous immunotherapy.My cancer has spread to my brain and is getting worse or hasn't been treated.I have or had cancer spread to the lining of my brain and spinal cord.I am 18 or older with advanced non-squamous NSCLC.I have a history of an autoimmune disease or idiopathic pulmonary fibrosis.I have undergone at least one treatment for my condition.I was treated with a checkpoint inhibitor before joining this trial.I am currently being treated for another type of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab and Tocilizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.