Recruiting
Phase 2

Durvalumab

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05696782

Conditions

Nonsmall Cell Lung Cancer Stage III

Unresectable Non-Small Cell Lung Carcinoma

Nonsmall Cell Lung Cancer, Stage II

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Durvalumab

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

COPD Assessment Test (CAT)

Modified Medical Research Council (mMRC) dyspnea scale

Study Details

Brief 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.

Conditions

Nonsmall Cell Lung Cancer Stage III

Unresectable Non-Small Cell Lung Carcinoma

Nonsmall Cell Lung Cancer, Stage II

Study ID

NCT05696782

Start date

Jul 26, 2023

Status verified date

Jul, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have stage II or stage III NSCLC confirmed by histologic or cytologic documentation and by clinical assessment. Staging is defined according to the AJCC Cancer Staging Manual, 8th Edition (2017).
  • Unresectable or medically inoperable as determined by the investigator.
  • The patient 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 NSCLC 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 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.

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Quick Start Durvalumab

Standard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion

Interventions

Durvalumab

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)

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)

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

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.

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 and Locations

Central contacts

Jada Kluttz

336-713-0901Jada.Kluttz@Advocatehealth.org

Locations

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Jada Kluttz

336-713-0901Jada.Kluttz@Advocatehealth.org

Principal Investigator:

Thomas Lycan, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-06.