Wake Forest University Health Sciences
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.
Nonsmall Cell Lung Cancer Stage III
Unresectable Non-Small Cell Lung Carcinoma
Durvalumab
the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
COPD Assessment Test (CAT)
Modified Medical Research Council (mMRC) dyspnea scale
Phase 2
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. Secondary Objectives: 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.
Study Type : | Interventional |
Estimated Enrollment : | 28 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Pilot Study of Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer |
Actual Study Start Date : | July 26, 2023 |
Estimated Primary Completion Date : | May 2025 |
Estimated Study Completion Date : | July 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Quick Start Durvalumab Standard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion |
Drug: Durvalumab Other: the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) Diagnostic Test: COPD Assessment Test (CAT) Diagnostic Test: Modified Medical Research Council (mMRC) dyspnea scale |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157