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 unresectable Stage II or Stage III 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 unresectable Stage II or Stage III nonsmall cell lung cancer. * Assess barriers to earlier Durvalumab initiation following chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer. * Describe the toxicity of Durvalumab when initiated quickly after chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer as compared to historical controls. * Describe the efficacy of Durvalumab when initiated quickly after chemoradiation for unresectable Stage II or Stage III nonsmall cell lung cancer as compared to historical controls.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Participants will receive Durvalumab 1500 mg intravenously every two weeks for 60 minutes. Each treatment is called a cycle and lasts for four weeks (or 28 days).
Participants will be asked to answer all 30 items on the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). This patient-reported outcome measure is designed to measure cancer patients' physical, psychological and social functions. The measure can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is approximately 11 minutes (
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
RECRUITINGNumber of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days)
Fidelity is defined as a dichotomous composite indicator (yes/no) that describes whether the patient received very early (1-7 days) initiation of Durvalumab as per protocol with all four of the following criteria having been met: (i) CT chest obtained after the last day of radiation therapy and before the first infusion of Durvalumab, (ii) first infusion within 14 days of completing radiation therapy, (iii) second and third doses received within 63 days of the first dose, and (iv) all infusions at least 28 days apart.
Time frame: 48 weeks
Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Very Early (1-7 days)
Fidelity is defined as a dichotomous composite indicator (yes/no) that describes whether the patient received very early (1-7 days) initiation of Durvalumab as per protocol with all four of the following criteria having been met: (i) CT chest obtained after the last day of radiation therapy and before the first infusion of Durvalumab, (ii) first infusion within 7 days of completing radiation therapy, (iii) second and third doses received within 63 days of the first dose, and (iv) all infusions at least 28 days apart.
Time frame: Up to 13 months
Number of Barriers to Initiation of Durvalumab - Very Early (Days 1-7)
Descriptive frequencies of participant survey answers will be examined to conduct qualitative analyses and determine appropriate categories of answers on the free text responses. We will examine barriers/obstacles for everyone in the sample, even those who achieve fidelity; such patients could have experienced delays even if they were still able to achieve fidelity. We will stratify answers/responses by fidelity status.
Time frame: Up to 13 months
Number of Barriers to Initiation of Durvalumab - Early (Days 8-14)
Descriptive frequencies of participant survey answers will be examined to conduct qualitative analyses and determine appropriate categories of answers on the free text responses. We will examine barriers/obstacles for everyone in the sample, even those who achieve fidelity; such patients could have experienced delays even if they were still able to achieve fidelity. We will stratify answers/responses by fidelity status.
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Participants will be asked to answer all items on the COPD assessment test (8 items) and the patient-reported outcome measures designed to measure respiratory function. The measures can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is less than 5 minutes.
Participants will be asked to answer the modified medical research council dyspnea scale (1 item), and the patient-reported outcome measures designed to measure respiratory function. The measures can be completed using a paper form, by verbally providing answers to the study team, or by entering the answers online into REDCap using a computer or mobile device. The total time to complete the questionnaire is less than 5 minutes.
Time frame: Up to 13 months
Number of Participants with All Adverse Events
Adverse events, serious adverse events and immune-related adverse events will be tabulated by fidelity status (1-7 days vs. 8-14 days vs. neither) using National Cancer Institute Common Terminology Criteria, version 5.0.
Time frame: Up to 13 months after intervention
Number of Participants Who Have Immune-Mediated Pneumonitis - Early Fidelity (1-14 days)
Participants with early (1-14 days) fidelity who have immune-mediated early-onset pneumonitis will be estimated and statistically compared in a one-sample test of proportions.
Time frame: Within 85 days of intervention (Cycles 1-3)
Number of Participants Who Have All-Cause Any Grade Pneumonitis - Early Fidelity (1-14 days)
Participants with all-cause early-onset pneumonitis among those with early (1-14 days) fidelity and statistically compare it, using a one-sample test of proportions.
Time frame: Within 85 days of intervention (Cycles 1-3)
Number of Participants to Discontinue Durvalumab Due to Adverse Events
Participants with early fidelity who discontinue Durvalumab at any point due to an adverse event of any cause and compare it using a one-sample test of proportions.
Time frame: One year
Overall Survival
Using Kaplan-Meier life table methods, overall survival is defined as the number of participants alive at 12 months after the first dose of Durvalumab.
Time frame: One year
Progression-Free Survival
Using Kaplan-Meier methods, progression-free survival is defined as the number of participants alive and without disease progression as documented by the treating provider at 12 months after the first dose of Durvalumab.
Time frame: One year
Response Rate
Best objective response rate (ORR) to Durvalumab is defined by either a complete response (CR) or partial response (PR) as per RECIST 1.1 criteria by investigator assessment and confirmed on at least two sequential imaging studies that are at least four weeks apart. * Complete Response (CR): Disappearance of all target lesions. * Partial Response (PR): Decrease by ≥ 30% in sum of longest diameter of target lesions.
Time frame: One year