New radioactive 'Smart Bomb' targets Hard-to-Treat lung cancer
NCT ID NCT07278479
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug that delivers radiation directly to cancer cells carrying a protein called DLL3, found in small cell lung cancer and other solid tumors. The trial enrolls 138 adults whose cancer has progressed after at least two prior treatments. The goal is to check safety, find the right dose, and see if the drug can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A radioactive drug that targets DLL3 on cancer cells
- What this could lead to
- If it works, this could provide a new treatment option for people with advanced small cell lung cancer that has stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial (phase 1/2a) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Radiation-based drugs can cause side effects like damage to healthy tissues.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Sep 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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.
Key Inclusion Criteria: * Age ≥ 18 years old * Histologically or cytologically confirmed: I. advanced extensive or limited SCLC or LC NECs of the lung * SCLC (extensive stage, or limited stage) patients with progression or recurrence following at least two prior line of systemic platinum based therapy and immunotherapy or are not suitable or tolerating the standard of care treatment as second line of systemic therapy, or * LC NEC of the lung patients with progression or recurrence following at least one prior line of systemic therapy, or II. epNECs with progression or recurrence following at least one prior line of systemic therapy: * Gastroenteropancreatic NECs (GEPNEC), or * Cervical NECs, or * Bladder NECs, or * other epNECs with previously confirmed DLL3 expression by IHC. * Patients with prior DLL3-targeted therapy are allowed. * For epNECs in Part 1 and Part 2 and SCLC or LC NECs of the lung in Part 2: DLL3-positivity by \[203Pb\]Pb-DOTAM-MAM279 SPECT/CT * Radiographically documented disease progression or recurrence during or after the last line of systemic treatment therapy * At least one measurable disease per RECIST v1.1. * Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening * Adequate blood counts: Hemoglobin ≥9 g/dL; Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L; Platelets ≥100 × 10\^9/L; White blood cells (WBC) ≥2.5 x 10\^9/L; * Adequate hepatic function * Adequate renal function: Calculated glomerular filtration rate (GFR) \>60mL/min (using Cockroft-Gault formula). * Patients with known central nervous system (CNS) metastasis will be eligible if they are clinically stable. Key Exclusion Criteria: * Uncontrolled intercurrent illness * Patients who have not had resolution of all clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for grade ≤2 alopecia, or stable grade 2 sensory neuropathy, according to the last CTCAE version). * Active clinically significant cardiac disease * Evidence of interstitial lung disease or active, non-infectious pneumonitis. * History of other malignancy within the past 2 years with exceptions. Other protocol-defined inclusion/exclusion criteria may apply.
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Get notified about this study
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Emory University Hospital
RECRUITINGAtlanta, Georgia, 30322, United States
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Nebraska Cancer Specialists
RECRUITINGOmaha, Nebraska, 68130, United States
Contact Email: •••••@•••••
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United Theranostics
RECRUITINGGlen Burnie, Maryland, 21061, United States
Contact Email: •••••@•••••
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United Theranostics
RECRUITINGPrinceton, New Jersey, 08540, United States
Contact Email: •••••@•••••
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University Hospitals Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can armored CAR t cells take down Hard-to-Treat neuroendocrine cancers?
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- Could a hidden nerve condition be more common in lung cancer than we think?
- Can a Triple-Drug combo outsmart a rare and aggressive cancer?
- Can a gentler drug trio tame small cell lung cancer in older patients?