Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer

Trial Title: Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer

NCT ID: NCT05696782

Condition: Nonsmall Cell Lung Cancer Stage III
Unresectable Non-Small Cell Lung Carcinoma

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Durvalumab

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Durvalumab
Description: 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).
Arm group label: Quick Start Durvalumab

Intervention type: Other
Intervention name: the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
Description: 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 (
Arm group label: Quick Start Durvalumab

Intervention type: Diagnostic Test
Intervention name: COPD Assessment Test (CAT)
Description: 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.
Arm group label: Quick Start Durvalumab

Intervention type: Diagnostic Test
Intervention name: Modified Medical Research Council (mMRC) dyspnea scale
Description: 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.
Arm group label: Quick Start Durvalumab

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients must have Stage III nonsmall cell lung cancer confirmed by histologic or cytologic documentation and by clinical assessment. Stage III nonsmall cell lung cancer is defined 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. Exclusion Criteria: - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Wake Forest Baptist Comprehensive Cancer Center

Address:
City: Winston-Salem
Zip: 27157
Country: United States

Status: Recruiting

Contact:
Last name: Study Nurse

Phone: 336-713-7748
Email: saverill@wakehealth.edu

Investigator:
Last name: Thomas Lycan, MD
Email: Principal Investigator

Start date: July 26, 2023

Completion date: July 2026

Lead sponsor:
Agency: Wake Forest University Health Sciences
Agency class: Other

Source: Wake Forest University Health Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05696782