New combo therapy shows promise for tough lung cancer
NCT ID NCT03589547
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of an immune-boosting drug (durvalumab) and a precise, high-dose radiation treatment (SBRT) for people with stage III lung cancer that hadn't spread. The goal was to see if adding SBRT after standard chemoradiation could help control the cancer longer. Eleven participants were enrolled to check safety and how well the treatment worked.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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11 people
The number who actually took part.
- Started
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May 2019
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). * 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. Exclusion Criteria: * 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). * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rhode Island Hospital
Providence, Rhode Island, 02903, United States
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The Miriam Hospital
Providence, Rhode Island, 02906, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Gene-Hacked immune cells take on tough cancers
- Thymus gland may hold key to preventing immune cell loss during lung cancer treatment
- Lung cancer radiation study pulled before it even started
- New lung cancer combo aims to boost treatment completion
- Blood test may personalize lung cancer therapy