RecruitingPhase 2NCT05696782

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

Phase II Pilot Study of Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer

Sponsor

Wake Forest University Health Sciences

Enrollment

28 participants

Start Date

Jul 26, 2023

Study Type

INTERVENTIONAL

Conditions

Nonsmall Cell Lung Cancer Stage III Unresectable Non-Small Cell Lung Carcinoma Nonsmall Cell Lung Cancer, Stage II

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether starting durvalumab — an immunotherapy drug — very quickly after completing chemoradiation for stage II or III non-small cell lung cancer leads to better outcomes than the standard approach of waiting. **You may be eligible if...** - You have stage II or III non-small cell lung cancer that is confirmed by biopsy - Your cancer cannot be removed with surgery - You are receiving or about to receive radiation therapy (54–66 Gy) and platinum-based chemotherapy for your lung cancer - You completed chemoradiation within the last 14 days, are currently receiving it, or will start within 28 days **You may NOT be eligible if...** - You have autoimmune diseases that could be worsened by immunotherapy - You are on immune-suppressing medications - You are pregnant or breastfeeding - Your cancer has spread to distant organs (stage IV) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab

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).

OTHERthe EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)

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 (

DIAGNOSTIC_TESTCOPD Assessment Test (CAT)

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.

DIAGNOSTIC_TESTModified Medical Research Council (mMRC) dyspnea scale

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.

Locations(1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

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