← Back to Search

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

Must not have

History of certain pulmonary conditions or evidence of active pneumonitis on screening chest CT scan

Significant cardiovascular disease within 3 months prior to initiation of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

My NSCLC is stage II to IIIA with PD-L1 expression in at least 1% of tumor cells, after surgery and chemotherapy.

Select...

My cancer has high PD-L1 levels and no EGFR or ALK mutations.

Select...

I have NSCLC and am eligible for atezolizumab treatment.

Select...

I am at least 18 years old.

Select...

I can take care of myself and perform daily activities.

Select...

The skin where I will get the injection is clear of tattoos, color changes, or marks.

Select...

My kidney function is within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of lung conditions or signs of lung inflammation.

Select...

I haven't had major heart problems in the last 3 months.

Select...

I have had cancer spread to the lining of my brain and spinal cord.

Select...

My calcium levels are abnormally high and not under control.

Select...

I have pain from my cancer that isn't relieved by treatment.

Select...

I frequently need procedures to remove excess fluid from my chest or abdomen.

Select...

I have brain metastases that haven't been treated or didn't respond to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Healthcare provider and mobile nurse satisfaction with home administration of atezolizumab

Patient satisfaction with home administration of atezolizumab

Other study objectives

Overall response rate

Progression free survival rate

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: 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.

0 / 14Eligibility criteria met