Lung Cancer Clinical Trial
Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
This research study aims to determine what effects (good and bad) Durvalumab has on participants and their cancer with a "quick start" of Durvalumab within 14 days of finishing chemotherapy and radiation. The study will also determine the logistic barriers to the quick start of Durvalumab.
Primary Objective: Assess the treatment fidelity for early Durvalumab initiation (i.e., within 14 days after the last day of radiation therapy) following chemoradiation for Stage III, unresectable nonsmall cell lung cancer.
Assess the treatment fidelity for very early Durvalumab initiation (i.e., within seven days after the last day of radiation therapy) following chemoradiation for Stage III, unresectable nonsmall cell lung cancer.
Assess barriers to earlier Durvalumab initiation following chemoradiation for Stage III nonsmall cell lung cancer.
Describe the toxicity of Durvalumab when initiated quickly after chemoradiation for Stage III nonsmall cell lung cancer as compared to historical controls.
Describe the efficacy of Durvalumab when initiated quickly after chemoradiation for Stage III nonsmall cell lung cancer as compared to historical controls.
Describe the patient-reported outcomes of Durvalumab when initiated quickly after chemoradiation for Stage III nonsmall cell lung cancer as compared to historical controls.
Histological or cytological documentation of nonsmall cell lung cancer that is Stage III according to the American Joint Committee on Cancer Staging Manual, 8th Edition (2017).
Unresectable or medically inoperable as determined by the investigator.
The participant has definitive radiation therapy (e.g., 54 Gy to 66 Gy in 30 to 35 fractions) for lung cancer that is either (a) planned to start within the next 28 days, or (b) currently being administered, or (c) has been completed within the last 14 days.
Platinum-based chemotherapy for lung cancer that is either (a) planned to start within the next 28 days, (b) currently being administered, or (c) has been completed within the last 14 days. Chemotherapy must be for at least two cycles and be administered either before radiation therapy ("induction" or "sequential") or during radiation therapy ("concurrent").
Consolidation Durvalumab is planned for nonsmall cell lung cancer after radiation and chemotherapy.
Eighteen years old or greater.
ECOG performance status of 0-2.
Life expectancy of greater than three months.
Patients with sexual relationships in which either they or their partner may become pregnant must use contraception during the study treatment period.
Ability to understand and be willing to sign an IRB-approved informed consent document directly or via a legally authorized representative.
Uncontrolled respiratory symptoms (i.e., cough, dyspnea, fevers, chest pain, or an increase from baseline oxygen requirements) that are interfering with activities of daily living.
Nonsmall cell lung cancer is known to have progressed during radiation therapy.
Nonsmall cell lung cancer is known to have a tumor with a mutation in EGFR associated with sensitivity to first-line therapy with a tyrosine kinase inhibitor (i.e., Ex19del, L858R, EGFR S768I, L861Q, or G719X). If not already known, testing for EGFR mutations is not required for study enrollment.
Prior exposure to an immune checkpoint inhibitor targeting CTLA-4, PD-1, or PD-L1.
Active autoimmune disease requiring systemic immunosuppression at the time of enrollment.
History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone >20 mg/day for more than one week).
Uncontrolled intercurrent illness includes ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients who are pregnant or breastfeeding.
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There is 1 Location for this study
Winston-Salem North Carolina, 27157, United States More Info
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