RecruitingPhase 2NCT05696782
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDurvalumab and the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 22, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Wake Forest University Health Sciences
Interventions being studied
Drug: Durvalumab; Other: the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30); Diagnostic Test: COPD Assessment Test (CAT); Diagnostic Test: Modified Medical Research Council (mMRC) dyspnea scale
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Atrium Health Levine CancerCharlotte, North Carolina
  • Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 22, 2026. Always confirm current availability with the study team.

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