Study on Durvalumab and Chemotherapy Before and After Surgery for Treating Resectable Non-small Cell Lung Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03800134
This Phase III clinical trial is testing whether adding the drug durvalumab to chemotherapy before surgery can improve treatment outcomes for patients with resectable non-small cell lung cancer (NSCLC), compared to chemotherapy alone.
Patient Parameters
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Program Overview
This international study is exploring the effectiveness of using durvalumab, an immunotherapy drug, along with chemotherapy before surgery in patients with resectable non-small cell lung cancer (NSCLC). The trial aims to see if this combination can lead to a better pathological complete response, meaning no signs of cancer in tissue samples after treatment, compared to using chemotherapy alone with a placebo.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have a new diagnosis of non-small cell lung cancer (NSCLC) that can be surgically removed, specifically in stages IIA to certain types of stage IIIB.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have at least one measurable tumor that has not been treated with radiation.
- Have not received any previous immune-based cancer treatments.
- Have adequate organ and bone marrow function.
- Have a confirmed PD-L1 status of the tumor.
- Provide a tumor biopsy sample to check for specific genetic markers (EGFR and ALK).
- Plan to have surgery that involves removing part of the lung (lobectomy, sleeve resection, or bilobectomy).
Exclusion Criteria
- Have had an organ transplant from another person.
- Have active or past autoimmune or inflammatory diseases, such as lupus or inflammatory bowel disease.
- Have had another type of cancer in the past.
- Have a primary immune deficiency.
- Have an active infection like tuberculosis, hepatitis B or C, or HIV.
- Have lung cancer that cannot be surgically removed.
- Have received radiation therapy before surgery as part of the treatment plan.
- Have cancer that has spread to the brain or spinal cord.
- Have advanced stages of lung cancer (Stage IIIB N3, IIIC, IVA, or IVB).
- Have an allergy to any of the study drugs.
- Have more than one type of lung cancer.
- Plan to have surgery that involves removing the entire lung or smaller parts like segments or wedges.
- Have specific genetic changes in the tumor (EGFR mutation or ALK translocation).
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85054 | Phoenix | Arizona |
| Research Site | 91010 | Duarte | California |
| Research Site | 92868 | Orange | California |
| Research Site | 80012 | Aurora | Colorado |
| Research Site | 33486 | Boca Raton | Florida |
| Research Site | 32256 | Jacksonville | Florida |
| Research Site | 60612 | Chicago | Illinois |
| Research Site | 67214 | Wichita | Kansas |
| Research Site | 41101 | Ashland | Kentucky |
| Research Site | 40513 | Lexington | Kentucky |
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