Testing a New Immunotherapy Drug, Atezolizumab, with Usual Chemoradiation for Limited Stage Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03811002
This study is exploring whether adding the immunotherapy drug atezolizumab to the standard treatment of chemotherapy and radiation can improve outcomes for patients with limited stage small cell lung cancer.
Patient Parameters
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Program Overview
This phase III clinical trial is investigating how well the combination of chemotherapy and radiation therapy, with or without the addition of the immunotherapy drug atezolizumab, works in treating patients with limited stage small cell lung cancer (LS-SCLC). Chemotherapy drugs like etoposide, cisplatin, and carboplatin help stop cancer cells from growing and spreading. Radiation therapy uses high-energy x-rays to kill cancer cells. Atezolizumab is an immunotherapy drug that may help the immune system attack cancer cells. The study aims to see if adding atezolizumab to the usual treatment can improve patient outcomes.
Description
The main goal of this study is to compare the overall survival of patients with limited stage small cell lung cancer (LS-SCLC) who receive chemoradiation with or without atezolizumab. Secondary goals include comparing how long patients live without the cancer getting worse, the response rate to treatment, and the control of cancer spread. The study will also look at the side effects of the treatment, quality of life, and fatigue levels.
Patients will be randomly assigned to one of two groups:
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Group 1: Patients receive standard chemotherapy with etoposide and either cisplatin or carboplatin, along with radiation therapy. This treatment is repeated every 21 days for 3 cycles, unless the cancer progresses or side effects become too severe.
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Group 2: Patients receive the same treatment as Group 1, plus atezolizumab, an immunotherapy drug, given every 3 weeks for up to 17 cycles (1 year), unless the cancer progresses or side effects become too severe.
After completing the study treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for 3 years, and annually after that.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with limited stage small cell lung cancer (LS-SCLC) within the last 60 days.
- Have received one cycle of chemotherapy with platinum/etoposide before joining the study.
- Have measurable cancer based on specific medical criteria.
- Completed a physical exam and specific scans within the required timeframes before joining the study.
- Be 18 years or older.
- Be in good overall health with an ECOG performance status of 0-2.
- Have adequate blood cell counts and organ function based on specific tests.
- Women of childbearing potential must have a negative pregnancy test before joining the study.
- Agree to provide informed consent and follow study procedures.
- Have been tested for hepatitis B/C and HIV, with specific conditions for eligibility.
Exclusion Criteria
- Have evidence of cancer spread beyond the lungs.
- Have had surgery to remove small cell lung cancer.
- Have had more than one cycle of chemotherapy for small cell lung cancer before joining the study.
- Have received atezolizumab or other immunotherapy drugs before.
- Have had radiation therapy to the lungs that would overlap with the study treatment.
- Have certain autoimmune diseases or other serious health conditions that could interfere with the study.
- Be pregnant or breastfeeding, or not willing to use contraception during and after the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| CTCA at Western Regional Medical Center | 85338 | Goodyear | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Sutter Auburn Faith Hospital | 95602 | Auburn | California |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
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