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Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer

Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer

Recruiting
18 years and older
All
Phase 3

PRIMARY OBJECTIVE:

I. To compare overall survival (OS) in patients with inoperable, early stage non-small cell lung cancer (NSCLC) randomized to stereotactic body radiation therapy (SBRT) with or without atezolizumab.

SECONDARY OBJECTIVES:

I. To compare investigator-assessed progression-free survival (IA-PFS) between the arms.

II. To compare progression free survival (PFS) by blinded independent centralized review (BIRC) between the arms in a random subset of patients.

III. To evaluate distant, locoregional, and local failure rates within each treatment arm.

IV. To evaluate the frequency and severity of toxicities within each treatment arm.

ADDITIONAL OBJECTIVE:

I. To collect specimens for banking.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Treatment repeats every 21 days for 8 cycles. Starting on day 1 cycle 3, patients also undergo SBRT for 3-5 treatments over 1-3 weeks.

ARM B: Beginning 21 days after randomization, patients undergo SBRT for 3-5 treatments over 1-3 weeks.

After completion of study treatment, patients are followed up at weeks 18, 30, 42, and 54, every 6 months for 2 years, and then every 12 months for 2 years.

Study details
    Lung Non-Small Cell Carcinoma
    Stage I Lung Cancer AJCC v8
    Stage IA1 Lung Cancer AJCC v8
    Stage IA2 Lung Cancer AJCC v8
    Stage IA3 Lung Cancer AJCC v8
    Stage IB Lung Cancer AJCC v8
    Stage IIA Lung Cancer AJCC v8

NCT04214262

National Cancer Institute (NCI)

19 February 2024

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