Atezolizumab + Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byKaren Kelly

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Megan Daly, MD

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of a special drug and precise radiation therapy for patients with early-stage lung cancer who can't have surgery. The drug boosts the immune system, and the radiation directly attacks the tumor.

Research Team

Karen Kelly

Principal Investigator

University of California, Davis

Eligibility Criteria

Inclusion Criteria

Tumor diameter >= 2 cm

Tumor standardized uptake value maximum (SUVmax) >= 6.2

Moderately, poorly differentiated or undifferentiated histology

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Exclusion Criteria

Positive for human immunodeficiency virus (HIV), hepatitis B (hepatitis B surface antigen [HBsAg] reactive), or hepatitis C virus (hepatitis C virus ribonucleic acid [HCV RNA] [qualitative] is detected)

Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment

You have other health conditions that are not being properly managed or controlled.

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Treatment Details

Interventions

Atezolizumab (Checkpoint Inhibitor)
Stereotactic Body Radiation Therapy (Radiation)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: atezolizumab + SBRTExperimental Treatment2 Interventions

DOSE ESCALATION PHASE: Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Within 24-48 hours after receiving atezolizumab, patients also undergo 4-5 fractions of stereotactic body radiation therapy over days 1-5 of course 3. EXPANSION PHASE: Patients receive atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Within 24-48 hours after receiving atezolizumab, patients also undergo 4-5 fractions of stereotactic body radiation therapy over days 1-5 of course 3.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: