This phase II trial tests how well durvalumab works in treating patients with stage II or III non-small cell lung cancer (NSCLC). It is unclear when the best time is to begin durvalumab treatment after finishing chemoradiation. The original clinical trials designed durvalumab to be given quickly after the last day of radiation therapy (less than 14 days) because this may help the drug to work better. But in routine clinical practice, durvalumab is rarely given less than 14 days after radiation therapy; it is nearly always given after 30 days or more. Study doctors want to learn what effects (good and bad) durvalumab has on cancer with a "quick start" within 14 days of finishing chemotherapy and radiation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05696782.
Locations matching your search criteria
United States
North Carolina
Charlotte
Carolinas Medical Center/Levine Cancer InstituteStatus: Active
Contact: Kathryn Finch Mileham
Phone: 980-442-2000
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Thomas William Lycan
Phone: 336-716-0230
PRIMARY OBJECTIVE:
I. Assess the treatment fidelity for early durvalumab initiation (i.e., within 14 days after the last day of radiation therapy) following chemoradiation for unresectable stage II or stage III NSCLC.
SECONDARY OBJECTIVES:
I. Assess the treatment fidelity for very early durvalumab initiation (i.e., within seven days after the last day of radiation therapy) following chemoradiation for unresectable stage II or stage III NSCLC.
II. Assess barriers to earlier durvalumab initiation following chemoradiation for unresectable stage II or stage III NSCLC.
III. Describe the toxicity of durvalumab when initiated quickly after chemoradiation for unresectable stage II or stage III NSCLC as compared to historical controls.
IV. Describe the efficacy of durvalumab when initiated quickly after chemoradiation for unresectable stage II or stage III NSCLC as compared to historical controls.
EXPLORATORY OBJECTIVE:
I. Describe the patient-reported outcomes of durvalumab when initiated quickly after chemoradiation for unresectable stage II or stage III NSCLC as compared to historical controls.
II. Describe the circulating immunophenotype of patients who develop an immune-related adverse event (irAE) to patients who do not develop an irAE among patients treated with quick start durvalumab following chemoradiation for unresectable stage II or stage III NSCLC.
III. Test the feasibility of measuring the change in levels of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) before the quick start of durvalumab, after three cycles of durvalumab, and at the time of cancer progression (if progression occurs after starting durvalumab) as a possible avenue for disease surveillance.
OUTLINE:
Patients receive durvalumab intravenously (IV), over 60 minutes, on day 1 of each cycle. Cycles repeat every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT) of the brain during screening, CT of the chest on study and during follow up, and blood sample collection during screening and on study.
After completion of study treatment, patients are followed up at days 28 and 347.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorThomas William Lycan
