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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  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).
• the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) — OTHER
  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 (
• COPD Assessment Test (CAT) — DIAGNOSTIC_TEST
  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.
• Modified Medical Research Council (mMRC) dyspnea scale — DIAGNOSTIC_TEST
  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.

Study Details

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.

Key Dates

Start date

Jul 26, 2023

Status verified

Mar 2026

Primary completion

Feb 28, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

28 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Quick Start Durvalumab
  Standard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion

Primary Outcome Measure

Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days) [ Time Frame: 48 weeks ]

Central Contacts

• Study Coordinator
  336-713-0901
  [email protected]

Locations (1)

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