NCT04214262

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

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Lung Non-Small Cell Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Atezolizumab	Given IV
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT or PET/CT
OTHER	Fludeoxyglucose F-18	Undergo FDG PET/CT
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2020-08-13
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2020-01-02
• Last updated: 2026-04-13

Locations

391 sites across 1 country: United States

Regulatory

• FDA-regulated drug study