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Stage III Non-small-cell Lung CancerPhase 2358NCT03589547

Durvalumab and Consolidation SBRT Following Chemoradiation for Locally Advanced Stage III Non-Small Cell Lung

A Phase 2 study testing Durvalumab and SBRT in people with Stage III Non-small-cell Lung Cancer, run by Brown University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Durvalumab is a drug that stimulates the immune system to fight lung cancer. Durvalumab is FDA approved to treat lung cancer. Stereotactic body radiation therapy (SBRT) is a newer radiation treatment that gives fewer, but higher doses of radiation than standard radiation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage III Non-small-cell Lung Cancer
What is being tested?
Durvalumab and SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesUnited States
Study dates
13 May 2019to 18 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stage III NSCLC.
  • Completion of concurrent chemoradiation:
  • Radiation dose of 60.0 Gy (50-65Gy) using standard fractionation
  • Patients will receive the first dose of durvalumab > 3 weeks and < 7 weeks after their last treatment of chemoradiation (last radiation or chemotherapy treatment, whichever ended last).Sites are required to submit prior treatment (chemotherapy and radiation)
  • Residual tumor volume that is appropriate for SBRT
  • Residual Primary tumor <120cc (approximately 6cm diameter).
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  • Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL prior to registration.
  • Total bilirubin ≤ 1.5x upper institutional limit of normal (ULN), and AST and ALT ≤ 3x ULN.
  • ECOG performance status 0 to 1
  • Minimum life expectancy of 12 weeks as determined by treating physician.
  • Age > 18 years.
  • Voluntary, signed written informed consent.
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days of day 1 of treatment (post-menopausal women, defined as surgical menopause or lack or menses >12 months, do not need to have a pregnancy test, document status.)
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after the last treatment.
  • Resolution of all related toxicities from chemo/RT to < grade 2, except alopecia.
  • Patient must have tissue available from prior biopsy for correlative studies as confirmed by treating physician.

Who cannot join

  • Disease progression during or after standard chemoradiation
  • Prior thoracic radiation (other than the chemoradiation delivered prior to SBRT)
  • Metastatic disease
  • Uncontrolled severe, intercurrent illness as confirmed by the treating physician.
  • Chemotherapy within 3 weeks from the first treatment on study (day 1).
  • Prior complete resection of all NSCLC (patients could have undergone prior resection as long as it is not complete and the patient meets criteria and staging and tumor volume for registration).
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  • Severe, active co-morbidity, defined as follows:
  • Uncontrolled neuropathy ≥ grade 2 regardless of cause;
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
  • Transmural myocardial infarction within the last 6 months;
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
  • Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease.
  • HIV positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol unless patient is known to be HIV positive and they do not had a CD4 count result within 30 days prior to registration.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, not inclusive of patients who are HIV positive and who meet criterion above.
  • Note: Patients who require continuous or intermittent steroid therapy for non-autoimmune conditions, e.g. asthma, osteoarthritis or intravenous contrast allergy, are eligible permitted those patients who receive continuous steroids are limited to a dose of ≤10 mg/day of prednisone (or equivalent). Higher doses are permitted for intermittent therapy, e.g. for contrast allergy, but will need to be approved by BrUOG prior to registration.
  • Has a known history of active tuberculosis
  • Hypersensitivity to Durvalumab or any of its excipients
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Has known history of clinically significant pneumonitis
  • Has an active infection requiring intravenous systemic therapy at the time of registration
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating physician
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial as per the treating physician
  • Is pregnant or breastfeeding
  • Has received prior therapy with an anti-CTLA-4, -PD-1, -PD-L1, or -PD-L2 agent
  • Has a known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • The Miriam Hospital

    Providence, Rhode Island, 02906

Other trials in United States

About this study

Durvalumab is a drug that stimulates the immune system to fight lung cancer. Durvalumab is FDA approved to treat lung cancer. Stereotactic body radiation therapy (SBRT) is a newer radiation treatment that gives fewer, but higher doses of radiation than standard radiation.

With SBRT, radiation is focused toward the cancer and away from normal surrounding lung tissue. It is possible that when cancer cells are damaged by SBRT Durvalumab may be more effective in activating the immune system. SBRT is a standard FDA approved treatment for early stage (stage 1) lung cancer and is investigational in patients such as yourself with stage 3 lung cancer. The combination of Durvalumab and SBRT is investigational. This study will investigate the effects, good and bad, of the combination of Durvalumab and SBRT.

Being tested
Durvalumab, SBRT
Keywords
Lung cancer, NSCLC, Stage III, Post chemoradiation
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    Also called Imfinzi

    Durvalumab10mg/kg Q2 weeks (+/- 4 days) for a total of 12 months (maximum of 26 treatments total)

  • SBRTRadiation

    Also called Stereotactic body radiation

    SBRT boost will consist of 2 fractions delivered to the primary tumor only, over 1-2 weeks between the first and second treatments with durvalumab.

    The dose will consist of 20Gy (2 fractions of 10Gy)

    *3 fractions are allowed for centrally located tumors

Study groups in NCT03589547
Study groupRoleWhat they receive
Durvalumab and SBRTExperimentalDurvalumab 10mg/kg x 1 day, dose #1 to occur > 3 weeks and <7 weeks after last chemo/RT and prior to SBRT dose 1 (5-10 day time frame between Durvalumab and SBRT). SBRT boost will consist of 2 fractions delivered to the primary tumor only, over 1-2 weeks between the first and second treatments with durvalumab (see above for time frames). The dose will consist of 20Gy (2 fractions of 10Gy). 3 fractions are allowed for centrally located tumors Dose # 2 of durvalumab, (post SBRT) to be given 1-10 days post last SBRT. Durvalumab then to be given at 10mg/kg Q2 weeks (+/- 4 days) for a total of 12 months (maximum of 26 treatments total)
Receives: Drug: Durvalumab; Radiation: SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients experiencing grade 2 or higher toxicities during consolidation SBRT with concurrent durvalumab after chemoradiation for locally advanced stage III NSCLC

    This outcome will examine the safety and tolerability of the trial.

    Measured: Defined as the first 3 months of durvalumab.

  2. Average progression-free survival of chemoradiation followed by SBRT and durvalumab for patients with locally advanced stage III NSCLC.

    RECIST 1.1

    Measured: Every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression on average for about 5 years.

Secondary outcomes (3)

  1. Overall survival (OS)

    Measured: Every 2 months for the first 6 months, then every 4 months for 2 years then every 6 months for 2 years then yearly for about 5 years

  2. Average time to local-regional progression (LRP)

    Measured: Every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression for about 5 years.

  3. Time to distant metastasis (DM)

    Measured: Every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2018
  2. Study start13 May 2019
  3. Primary completion31 Jan 2024
  4. Study completion18 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03589547
Sponsor's protocol ID
BrUOG 358
Acronym
358
Status last verified
Mar 2026
First submitted
22 Jun 2018
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab and SBRT in people with Stage III Non-small-cell Lung Cancer, run by Brown University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients experiencing grade 2 or higher toxicities during consolidation SBRT with concurrent durvalumab after chemoradiation for locally advanced stage III NSCLC (time frame: Defined as the first 3 months of durvalumab.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03589547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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