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

Running, not enrolling · Phase 3

Conditions studied: Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT04214262

Run by

National Cancer Institute (NCI)

People needed

415

Starts

2020-08-13

Expected to finish

2027-06-09

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must have histologically or cytologically proven stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC), without radiographic evidence of nodal or distant involvement (N0M0). Patient may have T3 disease with the exclusion of pericardial involvement. Patients with multifocal tumors with no more than two lesions confirmed or suspected to be synchronous early stage NSCLCs are eligible provided at least one lesion is histologically or cytologically proven to be NSCLC and meets one or more high-risk features
• Disease must have one or more of the following high-risk features:
• Tumor diameter >= 2 cm (inclusive of any non-solid, ground glass component) as assessed by diagnostic CT
• Tumor standard uptake value (SUV) max >= 6.2 as assessed by FDG PET/CT
• Moderately differentiated, poorly differentiated, or undifferentiated histology
• Patient must have undergone diagnostic chest CT with or without contrast (IV contrast preferred) within 42 days prior to randomization. PET-CT may be used if the CT portion is of comparable diagnostic quality to a stand-alone CT. All disease must be assessed within 42 days prior to randomization
• Patient must have undergone FDG PET/CT of chest within 90 days prior to randomization
• Patient must not have evidence of hilar or mediastinal nodal involvement. Any patient with radiographically suspicious hilar or mediastinal nodes (including features such as non-calcified nodes with a short axis diameter > 1 cm, abnormal morphology, and/or elevated FDG avidity) must undergo cytologic sampling of suspicious nodes to rule out involvement prior to randomization. Mediastinal nodal sampling for other patients is optional. For cases in which the treating physician/multidisciplinary opinion is used to define nodes as "non-suspicious" (such as long-standing, stable enlarged nodes from other medical causes), the rationale must be clearly documented within the medical record
• Patient must have undergone history and physical examination within 28 days prior to randomization
• Patient must be medically or surgically inoperable as documented by the evaluating thoracic surgeon or multi-disciplinary tumor board consensus OR patient's unwillingness to undergo surgical resection must be clearly documented
• Patient must not have received any prior treatment for the current NSCLC diagnosis
• Patient must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment
• Patient must not have received treatment with systemic immunostimulatory or immunosuppressive agents, including corticosteroids, within 14 days prior to randomization
• Patient must be >= 18 years old
• Patient must have Zubrod performance status of 0-2
• Patient must have adequate liver function defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional upper level of normal (IULN) within 28 days prior to randomization
• Patient must have adequate renal function defined as calculated creatinine clearance >= 30 mL/min using the following formula. The serum creatinine value used in the calculation must have been collected within 28 days prior to randomization
• Patient must have absolute neutrophil count (ANC), platelets, and hemoglobin measured within 28 days prior to randomization. The purpose of these tests is to collect baseline values to compare with on-treatment values
• Patient must have thyroid-stimulating hormone (TSH) measured within 28 days prior to randomization. The purpose of this test is to collect baseline values to compare with on-treatment values
• Patient must not have significant cardiovascular disease (New York Heart Association [NYHA] class II or greater)
• Patient must not have myocardial infarction within 90 days prior to randomization
• Patient must not have unstable arrhythmias or unstable angina
• Patient must not have known left ventricular ejection fraction (LVEF) < 40% within 28 days prior to randomization
• NOTE: Assessment of LVEF by echocardiogram or multigated acquisition (MUGA) is not an eligibility requirement, but if a standard of care echocardiogram or MUGA was clinically indicated, the LVEF must not be < 40% within 28 days prior to randomization
• Patient must not have had an infection >= grade 3 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) within 28 days prior to randomization

Where it is running

• 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
• 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
• Loma Linda University Medical Center — Loma Linda, California, United States
• Veterans Affairs Loma Linda Healthcare System — Loma Linda, California, United States
• Tibor Rubin VA Medical Center — Long Beach, California, United States
• Los Angeles General Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• Memorial Medical Center — Modesto, California, United States
• Kaiser Permanente-Modesto — Modesto, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Saint Joseph Hospital - Orange — Orange, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Desert Regional Medical Center — Palm Springs, California, United States
• Kaiser Permanente-Richmond — Richmond, California, United States
• Kaiser Permanente-Roseville — Roseville, California, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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