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Neuroendocrine Tumor of the LungPhase 1NCT06941480

A Study of 177Lu-DTPA-SC16.56 in People With Neuroendocrine Carcinomas of the Lung and Prostate

A Phase 1 study testing PET/CT and 177Lu-DTPA-SC16.56 in people with Neuroendocrine Tumor of the Lung and Neuroendocrine Carcinoma of Lung, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to find out whether 177Lu-DTPA-SC16.56 is a safe treatment for people with small-cell lung cancer or neuroendocrine prostate cancer Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PET/CT and 177Lu-DTPA-SC16.56
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
7 sitesUnited States
Study dates
Dec 2026to May 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Subjects with histologically proven progressive metastatic high-grade neuroendocrine carcinomas of the lung (small-cell lung cancer) and prostate (neuroendocrine prostate cancer) that has relapsed following at least 1 line of standard chemotherapy i. Prostate cancer patients will be defined by either of the following criteria: ii. The presence of chromogranin staining on tissue iii. At least two of the pathogenic mutations of PTEN, RB1, or p53 iv. Disease exclusively involving the viscera v. Disease in which the PSA is <10 but the number of bone lesions is >20 vi. Histologic evidence of small cell carcinoma or other stains consistent with neuroendocrine disease (on the primary disease or metastases) vii. DLL3 positivity on previously available tissue specimens
  • Ability to understand and willingness to sign a written informed consent document
  • Aged 18 years or older at the time of signing consent
  • Progression of disease defined by one of the following occurring within 3 months of study entry:
  • At least a 20% increase in radiologically or clinically measurable disease; ii. Appearance of any new lesion; iii. For prostate cancer patients progression criteria will be per PCWG3: iv. Either v. A rising PSA over a sequence of at least 1-week intervals OR i. An increase in soft tissue disease to qualify for disease progression by RECIST 1.1 OR ii. Two new bone lesions by bone scintigraphy
  • Patients with metastatic disease by virtue of disease exclusively evident by PSMA PET will not be eligible. All patients must have metastatic disease by evidence of standard scintigraphic or anatomic imaging in accord with PCWG3
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  • At least one tumor lesion on CT or MR ≥ 2 cm
  • ECOG performance status 0 to 2
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Previous chemotherapy, immunotherapy, and/or investigational agents are allowed if completed ≥4 weeks prior to study entry. For patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry.
  • Preserved hematological function:
  • Hb ≥9.0 g/dL; ii. WBC ≥3000/mm3; iii. ANC≥1500/mm3; iv. Platelets ≥75.000/mm3
  • Preserved renal function:
  • Serum creatinine ≤1.7 mg/dL ii. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m2
  • Preserved hepatic function:
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN) or ≤ 5 x ULN if liver metastases are present ii. bilirubin ≤ 1.5 x ULN (unless considered due to Gilbert's syndrome or hemolysis)
  • Willingness to undergo baseline and follow up biopsy to obtain tissue for DLL3 IHC and genomic analyses
  • In order to proceed with the treatment with 177Lu-DTPA-SC16.56, patients must exhibit overexpression of DLL3, as SUVmax greater than in normal liver, in ≥80% of tumor lesions among the growing progressing lesions that are ≥2cm.

Who cannot join

  • History of anaphylactic reaction to humanized or human antibodies
  • History of severe allergic reaction to X-ray contrast medium despite premedication
  • Prior treatment with Rova-T (rovalpituzumab)
  • Women who are pregnant or unwilling to discontinue breastfeeding
  • Spinal cord compression or symptomatic/uncontrolled epidural disease, unless treated and stable for at least 1 week prior to enrolment.
  • Males and females of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 4 months for males and 7 months for females after receiving the therapeutic study drug. Acceptable methods of highly effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (men) in combination with hormonal birth control or intrauterine device (IUD) (women)
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  • Life expectancy < 6 months as assessed by the treating physician.
  • Unresolved toxicities from prior antitumor therapy, defined per Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, to to grade 1 or grade 0 or to levels dictated in the inclusion criteria.
  • Major surgery within 28 days of enrolment with the exception of biopsy and insertion of central venous catheter.
  • Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known parenchymal brain metastases and/or carcinomatous meningitis, unless these metastases have been treated and stabilized.
  • Unmanageable urinary incontinence rendering the administration of 177Lu-DTPA-SC16.56 unsafe (e.g., urinary catheterization not feasible).
  • Other ongoing invasive malignances (i.e., not carcinomas in situ, non-mm invasive urothelial cancer, or other non-invasive tumors), and prior cancers that have been treated that have a >30% likelihood of relapse within the next two years.
  • Subjects likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge.
  • Prostate cancer patients with mixed histologies (i.e., neuroendocrine and adenocarcinomas) are eligible provided that they meet all of the above eligibility criteria.
  • Patients for whom their clinicians believe would benefit by continuing their treatments for their disease to control any adenocarcinoma (such as ADT or other AR axis directed therapy) can and should remain on those treatments while on this protocol, if their clinician believes that it would be clinically beneficial to do so.
  • Concurrent chemotherapy, other radiopharmaceuticals of any type, and immunotherapy are excluded
  • Complementary approaches known to modulate PSA should not be taken while on this trial

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa Bodei, MD, PhD contact

212-639-7373

bodeil@mskcc.org

Michael Morris, MD contact

646-422-4471

morrism@mskcc.org

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Lisa Bodei, MD, PhD, 212-639-7373

  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

    Commack, New York, 11725

    Lisa Bodei, MD, PhD, 212-639-7373

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

    Lisa Bodei, MD, PhD, 212-639-7373

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

    Lisa Bodei, MD, PhD, 212-639-7373

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Lisa Bodei, MD, PhD, 212-639-7373

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

    Lisa Bodei, MD, PhD, 212-639-7373

    Lisa Bodei, MD

  • Memorial Sloan Kettering Nassau (Limited protocol activities)

    Rockville Centre, New York, 11553

    Lisa Bodei, MD, PhD, 212-639-7373

Other trials in United States

About this study

Official title: Characterizing the Theranostic Potential of DLL3-targeting Agents in High-grade Neuroendocrine Carcinomas of the Lung and Prostate

The purpose of this study is to find out whether 177Lu-DTPA-SC16.56 is a safe treatment for people with small-cell lung cancer or neuroendocrine prostate cancer

Being tested
PET/CT, 177Lu-DTPA-SC16.56
Keywords
Neuroendocrine Tumor of the Lung, Neuroendocrine Carcinoma of Lung, Neuroendocrine Carcinoma, Neuroendocrine Carcinoma of Prostate, 177Lu-DTPA-SC16.56, Memorial Sloan Kettering Cancer Center, 24-330
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

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

  • PET/CTDiagnostic test

    Participants will undergo 89Zr-DFO-SC16.56 Ab PET/CT

  • 177Lu-DTPA-SC16.56Biological

    177Lu-DTPA-SC16.56, to be administered within 2 weeks of the PET/CT

Study groups in NCT06941480
Study groupRoleWhat they receive
Participants with neuroendocrine carcinomas of the lungExperimentalNot described
Receives: Diagnostic Test: PET/CT; Biological: 177Lu-DTPA-SC16.56
Participants with neuroendocrine prostate cancerExperimentalNot described
Receives: Diagnostic Test: PET/CT; Biological: 177Lu-DTPA-SC16.56

What is being measured

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

  1. Maximum tolerated dose of 177Lu-DTPA-SC16.56

    Evaluating the safety and defining the MTD of 177Lu-DTPA-SC16.56 radiopharmaceutical therapy (RPT).

    Measured: Up to 36 months

Timeline

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

  1. First posted23 Apr 2025
  2. Study startDec 2026 (estimated)
  3. Primary completionMay 2030 (estimated)
  4. Study completionMay 2030 (estimated)

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06941480
Sponsor's protocol ID
24-330
Status last verified
Nov 2026
First submitted
16 Apr 2025
Last updated
4 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PET/CT and 177Lu-DTPA-SC16.56 in people with Neuroendocrine Tumor of the Lung and Neuroendocrine Carcinoma of Lung, run by Memorial Sloan Kettering Cancer Center at 7 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 18 inclusion and 18 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Lisa Bodei, MD, PhD (212-639-7373, bodeil@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose of 177Lu-DTPA-SC16.56 (time frame: Up to 36 months). 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 NCT06941480.

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 4 Nov 2026.

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