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Checkpoint Inhibitor
Atezolizumab for Lung Cancer
Phase 2
Recruiting
Led By Jorge J Nieva, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients with stage II to IIIA NSCLC whose tumors have PD-L1 expression on >= 1% of tumor cells, as determined by an FDA-approved test, following resection and platinum-based chemotherapy
Patients with high PD-L1 expression (PD-L1 stained >= 50% of tumor cells [TC >= 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering >= 10% of the tumor area [IC >= 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing whether atezolizumab, given at home via telemedicine, is safe and feasible for patients with non-small cell lung cancer.
Who is the study for?
This trial is for adults with non-small cell lung cancer who can receive atezolizumab, have high PD-L1 expression without certain genetic mutations, and a life expectancy of at least 3 months. They must be able to follow the study plan, use contraception if necessary, and have access to wifi or data for telemedicine. Exclusions include recent significant cardiovascular issues, other cancers within 3 years (with some exceptions), severe infections recently, pregnancy/breastfeeding intentions soon, uncontrolled symptoms related to cancer or autoimmune diseases.Check my eligibility
What is being tested?
The trial tests subcutaneous atezolizumab administered at home with telemedicine support in patients with non-small cell lung cancer. It aims to see if this method is safe and workable. Atezolizumab is an immunotherapy drug that may boost the immune system's ability to fight cancer by interfering with tumor growth.See study design
What are the potential side effects?
Atezolizumab might cause side effects like inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions where injected under the skin due to hyaluronidase component used for better absorption of the drug; allergic reactions are possible too.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My NSCLC is stage II to IIIA with PD-L1 expression in at least 1% of tumor cells, after surgery and chemotherapy.
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My cancer has high PD-L1 levels and no EGFR or ALK mutations.
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I have NSCLC and am eligible for atezolizumab treatment.
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I am at least 18 years old.
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I can take care of myself and perform daily activities.
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The skin where I will get the injection is clear of tattoos, color changes, or marks.
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My kidney function is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs) of home administration by a healthcare provider (HCP) of subcutaneous atezolizumab
Successful completion of home drug administration visits within the specified window
Secondary outcome measures
Healthcare provider and mobile nurse satisfaction with home administration of atezolizumab
Patient satisfaction with home administration of atezolizumab
Other outcome measures
Overall response rate
Progression free survival rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (atezolizumab and recombinant human hyaluronidase)Experimental Treatment2 Interventions
Patients receive atezolizumab and recombinant human hyaluronidase SC over 3-8 minutes on day 1. Cycles repeat every 3 weeks for 1 year (early-stage lung cancer) or up to 2 years (late-stage lung cancer) in the absence of disease progression or unacceptable toxicity.
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Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,652 Total Patients Enrolled
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,241 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,604 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your white blood cell count is normal without needing extra medication to support it.My liver and bone enzymes are within acceptable levels, even with my cancer spread.Your platelet count is at least 100,000 per microliter without needing a blood transfusion.My NSCLC worsened after platinum chemo, and I don't have EGFR or ALK mutations.Your bilirubin levels are within a normal range, except if you have Gilbert disease.My NSCLC is stage II to IIIA with PD-L1 expression in at least 1% of tumor cells, after surgery and chemotherapy.My cancer has high PD-L1 levels and no EGFR or ALK mutations.I have a history of lung conditions or signs of lung inflammation.Your disease can be seen on a CT or PET scan.I haven't had major heart problems in the last 3 months.I have had cancer spread to the lining of my brain and spinal cord.I have had treatment for any painful cancer spots before joining.I have not had major surgery in the last 4 weeks.My cancer has spread, but I don't feel pain or have symptoms from it.I have not had any cancer other than lung cancer in the past 3 years.My calcium levels are abnormally high and not under control.I have not had a severe infection in the last 4 weeks.You have had serious allergic reactions to certain medications.I have pain from my cancer that isn't relieved by treatment.I frequently need procedures to remove excess fluid from my chest or abdomen.I have an autoimmune disease or immune deficiency, with some exceptions.I haven't taken certain medications or therapies recently.You are allergic to certain parts of the atezolizumab medication.You are expected to live for at least 3 more months.I have NSCLC and am eligible for atezolizumab treatment.Your blood clotting test results should be within a certain range if you are not taking blood-thinning medication.I have brain metastases that haven't been treated or didn't respond to treatment.I am at least 18 years old.Your lymphocyte count is at least 0.5 x 10^9 per liter.I can take care of myself and perform daily activities.Your hemoglobin level is at least 90 grams per liter (or 9 grams per deciliter).Women who could become pregnant must have a negative pregnancy test within 14 days before starting the study.The skin where I will get the injection is clear of tattoos, color changes, or marks.My kidney function is within the required range.My blood thinner medication dose has been stable.Your blood albumin level is at least 25 grams per liter (2.5 grams per deciliter).
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (atezolizumab and recombinant human hyaluronidase)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do the benefits of Atezolizumab and Recombinant Human Hyaluronidase outweigh the risks?
"Atezolizumab and Recombinant Human Hyaluronidase's safety has been supported in some ways by data, but not efficacy. Thus, we have given it a score of 2."
Answered by AI
Are participants being enrolled in this clinical trial at this time?
"No, the trial has stopped recruiting patients as of their last update on November 12th, 2022 according to information found on clinicaltrials.gov. The study was first posted December 5th, 2020. There are 2098 other trials that are still recruiting patients."
Answered by AI
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