Study on Durvalumab and Tremelimumab for Limited Stage Small-Cell Lung Cancer After Chemoradiation
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03703297
This clinical trial is testing the effectiveness of the drugs Durvalumab and Tremelimumab, compared to a placebo, in patients with limited stage small-cell lung cancer who have not shown disease progression after receiving chemoradiation therapy.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate whether the drugs Durvalumab and Tremelimumab can help control limited stage small-cell lung cancer (LS-SCLC) in patients who have completed chemoradiation therapy and have not experienced any progression of their cancer. This is a Phase III trial, meaning it is in the later stages of testing to determine the effectiveness and safety of these treatments compared to a placebo.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with limited-stage small cell lung cancer (stage I-III).
- Completed 4 cycles of chemotherapy along with radiation therapy within 1 to 42 days before starting the study treatment. The chemotherapy must include platinum and IV etoposide, and the radiation therapy should be either 60-66 Gy over 6 weeks or 45 Gy over 3 weeks.
- Prophylactic cranial irradiation (PCI) may be given based on the doctor's decision and local practices, and must be completed 1 to 42 days before starting the study treatment.
- Cancer has not progressed after completing chemoradiation therapy.
- Expected to live at least 12 more weeks from the start of the study.
- In good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have extensive-stage small cell lung cancer.
- Have active or previously diagnosed autoimmune or inflammatory disorders.
- Have uncontrolled illnesses, such as interstitial lung disease.
- Have active infections, including tuberculosis, HIV, hepatitis B, or hepatitis C.
- Have received chemotherapy and radiation therapy separately, without any overlap.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85715 | Tucson | Arizona |
| Research Site | 95403 | Santa Rosa | California |
| Research Site | 06510 | New Haven | Connecticut |
| Research Site | 33901 | Fort Myers | Florida |
| Research Site | 32763 | Orange City | Florida |
| Research Site | 33705 | St. Petersburg | Florida |
| Research Site | 30060 | Marietta | Georgia |
| Research Site | 60141 | Hines | Illinois |
| Research Site | 46804 | Fort Wayne | Indiana |
| Research Site | 47303 | Muncie | Indiana |
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