Lung cancer patients get new hope from Drug-Radiation combo
NCT ID NCT02839265
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested a combination of FLT3 ligand immunotherapy (CDX-301) and stereotactic body radiotherapy (SBRT) in 33 adults with advanced non-small cell lung cancer that had worsened after standard treatments. The goal was to see if this approach could slow cancer growth. Patients received daily injections of the immunotherapy for five days starting with the first radiation session. The study measured how many patients were alive without their cancer getting worse after four months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FLT3 ligand (CDX-301) and stereotactic body radiotherapy
- What this could lead to
- If it works, this combination could offer a new treatment option for advanced lung cancer patients who have run out of standard therapies.
- What could go wrong
- This is a small, early-phase trial with only 33 participants, so results may not apply to everyone. The treatment also carries risks of serious side effects from both the drug and radiation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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33 people
The number who actually took part.
- Started
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Jul 2016
- Finished
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Nov 2024
- 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: * AJCC stage 3 or 4 histologically proven NSCLC not amenable to curative therapy * Age \>= 18 years * Prior treatment with at least one standard chemotherapy regimen or targeted agent prior to enrollment * Radiological assessment within 21 days prior to study entry demonstrating measurable disease that includes at least one pulmonary lesion . 1 cm in greatest dimension that would be amenable to SBRT and at least one measurable lesion that would be outside of the SBRT treatment fields * History/physical examination within 30 days prior to registration * ECOG performance status 0-2 * Signed, written informed consent Exclusion Criteria: * Less than 21 days between registration and the last receipt of chemotherapy, biotherapy, immunotherapy, radiotherapy (excluding palliative radiotherapy), or major surgery. Prior receipt of immunomodulatory therapy (eg: nivolumab) is permitted, as long as there has been a 21 day washout period following the most recent treatment. * Untreated central nervous system metastases. Patients with a history of brain metastases must have had no CNS-directed therapy within the past 60 days and radiological assessment within 30 days of study entry demonstrating a lack of progressive CNS disease * Ongoing or recent (within 21 days prior to study entry) use of high dose oral corticosteroids (.2 mg of dexamethasone daily or equivalent). Intranasal and/or inhaled corticosteroid use is permitted. * Any unresolved CTCAE grade \>2 toxicity from previous anti-cancer therapy. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study therapy (eg, hearing loss)may be enrolled after discussion with the principal investigators. * History of allogeneic organ transplant or autoimmune disease * Active malignancy, other than NSCLC, for which systemic therapy is indicated. History of adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy asides from hormonal therapy, adequately treated stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for \>= 5 years is permitted. * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by the treating physicians * The following laboratory results, within 10 days of first study drug administration: * Hemoglobin . 9.0 g/dL, Absolute neutrophil count . 1.5 x 109/L, Platelet count . 100 x 109/L * Serum creatinine . 1.5 x ULN and creatinine clearance (by Cockcroft-Gault formula) \< 60 mL/min * Women of child bearing potential: positive pregnancy test (serum)
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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
-
Montefiore Medical Center
The Bronx, New York, 10467, United States
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Other studies related to the condition(s) this trial covers.
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