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Quick Start Durvalumab for Stage III Lung Cancer

This study is looking at how well Durvalumab works when given soon after chemotherapy and radiation for people with unresectable (cannot be removed by surgery) Stage II or Stage III non-small cell lung cancer. Researchers want to see if starting Durvalumab within 14 days of finishing other treatments is practical and safe. You would receive Durvalumab intravenously (through a vein) every two weeks. The study will also look at any challenges in starting this treatment quickly and how it affects your quality of life and breathing. The main goal is to see how many participants can start Durvalumab early.

Study design
This is an interventional study planning to enroll 28 participants. The phase of the study is not specified.
What's involved
You would receive Durvalumab intravenously every two weeks for 60 minutes. You will also complete questionnaires about your quality of life and breathing function.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of early Durvalumab treatment will be measured at 48 weeks.

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NCT05696782

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~28 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Durvalumabthe EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)COPD Assessment Test (CAT)Modified Medical Research Council (mMRC) dyspnea scale

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days)
Measured over 48 weeks

Conditions

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

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

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

Who to contact

Jada Kluttz
[email protected]
336-713-0901
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days)48 weeks

    Fidelity is defined as a dichotomous composite indicator (yes/no) that describes whether the patient received very early (1-7 days) or early (days 8-14 days) initiation of Durvalumab as per protocol with all four of the following criteria having been met: (i) CT chest obtained after the last day of radiation therapy and before the first infusion of Durvalumab, (ii) first infusion within 14 days of completing radiation therapy, (iii) second and third doses received within 63 days of the first dose, and (iv) all infusions at least 28 days apart.