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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

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT04214262
Protocol IDs
S1914 (primary)
S1914
NCI-2019-08627
Study Sponsor
SWOG
NCI Full Details
http://clinicaltrials.gov/show/NCT04214262

Summary

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.

Objectives

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. To assess quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)-30 and EORTC-QLQ- Lung Cancer (LC)13 between the arms.

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.
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