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

Description

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Nonsmall Cell Lung Cancer Stage III
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients must have Stage II or Stage III nonsmall cell lung cancer confirmed by histologic or cytologic documentation and by clinical assessment. Staging 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.
  • * 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 a tumor with a mutation in EGFR associated with sensitivity to first-line therapy with a tyrosine kinase inhibitor (i.e., Ex19del or L858R). Testing for EGFR mutation must have been attempted for study enrollment. If EGFR testing is inconclusive (e.g., the biopsy's quantity or quality is not sufficient for testing to be performed) and there is low clinical suspicion for the presence of an EGFR mutation as determined by the investigator, then the patient is eligible.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Thomas Lycan, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Baptist Comprehensive Cancer Center

Study Record Dates

2026-07