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Lung cancer patients get new hope from Drug-Radiation combo

NCT ID NCT02839265

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

33 people

The number who actually took part.

Started

Jul 2016

Finished

Nov 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.