Atezolizumab + Radiation Therapy for Lung Cancer

Palo Alto (17 mi)

Overseen byMegan E Daly

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.

Eligibility Criteria

This trial is for adults with early-stage non-small cell lung cancer (NSCLC) who haven't had previous treatment. Participants must be medically inoperable or unwilling to undergo surgery, have no significant heart disease, active hepatitis B/C or tuberculosis, and not be pregnant. They should not have received recent immunosuppressive treatments and must agree to use effective contraception.

Inclusion Criteria

I am 18 years old or older.

My liver tests are within the normal range.

I do not have serious heart disease.

I can take care of myself and am up and about more than 50% of my waking hours.

I have been tested for hepatitis C recently and do not have an active infection.

I have not had a heart attack in the last 90 days.

I don't have a history of serious lung disease or current lung inflammation.

I have not received any treatment for my current lung cancer diagnosis.

I do not have active tuberculosis.

I cannot have surgery for my condition as decided by a surgeon or medical team, or I choose not to have surgery.

My cancer is aggressive, based on size, PET scan results, or cell type.

I haven't had a severe infection in the last 28 days.

I do not have irregular heartbeats or chest pain that is getting worse.

I don't have severe allergies to specific medical treatments or their components.

Treatment Details

The study tests adding Atezolizumab, an immune system-boosting drug, to standard radiation therapy compared to radiation alone. The goal is to see if combining these treatments improves outcomes for patients with stage I-IIA NSCLC by helping the body's own immune system fight cancer more effectively.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (atezolizumab, SBRT)Experimental Treatment8 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1 cycle 3, patients also undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.

Group II: Arm B (SBRT)Active Control7 Interventions

Beginning 21 days after randomization, patients undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy for: