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.
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. HEALTH-RELATED QUALITY OF LIFE (HRQOL) OBJECTIVE: I. This objective will not be met, as the study was closed following the first interim analysis. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive atezolizumab intravenously (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 once daily (QD) over 1-3 weeks. Patients undergo fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) during screening. Patients undergo blood sample collection and CT scans throughout the trial. ARM B: 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. After completion of study treatment, patients are followed for 5 years after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
415
Given IV
Undergo blood sample collection
Undergo CT or PET/CT
Undergo FDG PET/CT
Undergo PET/CT
Ancillary studies
Ancillary studies
Undergo SBRT
Providence Alaska Medical Center
Anchorage, Alaska, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States
Overall survival
Will compare overall survival between patients with inoperable, T1, T2, limited T3, N0M0 (early stage) non-small cell lung cancer randomized to stereotactic body radiation therapy with or without atezolizumab. Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model and estimated using a stratified Cox regression model.
Time frame: From date of randomization to date of death due to any cause, assessed up to 3 years
Progression free survival
Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model and estimated using a stratified Cox regression model.
Time frame: From date of randomization to date of first documentation of progression or death due to any cause, assessed up to 5 years
Incidence of adverse events
This study will utilize the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for toxicity and serious adverse event reporting.
Time frame: Up to 5 years
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Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
Kaiser Permanente Dublin
Dublin, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
...and 381 more locations