Study on Adding Atezolizumab to Radiation Therapy for Early Non-Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04214262
This clinical trial is exploring whether adding the drug atezolizumab to the usual radiation therapy can improve treatment outcomes for patients with early-stage non-small cell lung cancer (NSCLC).
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to determine if combining the immunotherapy drug atezolizumab with radiation therapy can better treat patients with stage I-IIA non-small cell lung cancer (NSCLC). Atezolizumab is a type of immunotherapy that may help the immune system attack cancer cells and prevent them from growing and spreading. Radiation therapy uses precise equipment to target and kill cancer cells with fewer doses, causing less damage to normal tissue. This study will compare the effectiveness of this combination treatment to radiation therapy alone.
Description
The main goal of this study is to compare the overall survival of patients with early-stage non-small cell lung cancer (NSCLC) who receive stereotactic body radiation therapy (SBRT) with or without the addition of atezolizumab. Secondary goals include comparing how long patients live without the cancer getting worse, evaluating the rates of cancer returning in different areas, and assessing the side effects of the treatments.
Patients will be randomly assigned to one of two groups:
-
Group A: Patients will receive atezolizumab through an IV every 21 days for up to 8 cycles, unless the cancer progresses or side effects become unacceptable. Starting on the first day of the third cycle, patients will also receive SBRT for 3-8 treatments over 1-3 weeks. Patients will have PET/CT scans and blood tests throughout the study.
-
Group B: Patients will receive SBRT for 3-8 treatments over 1-3 weeks, starting 21 days after being assigned to this group. They will also have PET/CT scans and blood tests throughout the study.
After completing the study treatment, patients will be monitored for 5 years.
Eligibility Criteria
Inclusion Criteria
- Must have stage I-IIA non-small cell lung cancer (NSCLC) confirmed by lab tests, with no signs of cancer spreading to lymph nodes or other parts of the body.
- Cancer must have certain high-risk features, such as a tumor size of 2 cm or larger, a high uptake value on PET/CT scans, or specific types of cell differentiation.
- Must have had a chest CT scan within 42 days before starting the study.
- Must have had a PET/CT scan of the chest within 90 days before starting the study.
- Must not have cancer in the lymph nodes or other parts of the body.
- Must have had a physical exam within 28 days before starting the study.
- Must be unable or unwilling to have surgery for lung cancer.
- Must not have had any previous treatment for the current lung cancer.
- Must not have had previous radiation to the chest that would interfere with the study treatment.
- Must not have taken certain immune system drugs within 14 days before starting the study.
- Must be 18 years or older.
- Must have a performance status score of 0-2, indicating good overall health.
- Must have adequate liver and kidney function based on specific blood tests.
- Must have certain blood cell counts measured within 28 days before starting the study.
- Must not have significant heart disease or recent heart attack.
- Must not have active infections or autoimmune diseases requiring treatment.
- Must not have active hepatitis B or C infections.
- Must have lung function tests done within 90 days before starting the study.
- Must not have a history of significant lung disease or active lung inflammation.
- Must not have other cancers that could interfere with the study.
- Must not be pregnant and must agree to use effective birth control during and after the study.
- Must not have active tuberculosis.
- Must not have received a live vaccine within 28 days before starting the study.
- Must not have allergies to atezolizumab or similar drugs.
- Must agree to provide samples for research and sign informed consent.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Kaiser Permanente-Deer Valley Medical Center | 94531 | Antioch | California |
| AIS Cancer Center at San Joaquin Community Hospital | 93301 | Bakersfield | California |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
| Tower Cancer Research Foundation | 90211 | Beverly Hills | California |
| Kaiser Permanente Dublin | 94568 | Dublin | California |
| Kaiser Permanente-Fremont | 94538 | Fremont | California |
| Kaiser Permanente-Fresno | 93720 | Fresno | California |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.