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Small Cell Lung CancerPhase 1/2NCT04199741

PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56

A Phase 1/2 study testing 89Zr-DFO-SC16.56, SC16.56, Phase I, Cohort 2 and SC16.56, Phase I, Cohort 3 in people with Small Cell Lung Cancer and Small Cell Lung Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
89Zr-DFO-SC16.56, SC16.56, Phase I, Cohort 2 and SC16.56, Phase I, Cohort 3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteUnited States
Study dates
11 Dec 2019to 11 Jun 2027
Phase
Phase 1/2
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

  • Subject Inclusion Criteria for Adult population
  • Signed, informed consent
  • Age 18 or more years
  • Histologically confirmed, SCLC, (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin; or other types of neuroendocrine tumor OR Histologically confirmed prostate cancer, with suspected or confirmed NEPC based upon clinical assays obtained prior to the trial OR Histologically confirmed or suspected primary brain neoplasm OR Desmoplastic small round cell tumors, osteosarcoma, Ewing's sarcoma, rabdomyosarcoma, Wilms tumors, hepatoblastomas, rhabdoid tumors and neuroblastoma patients
  • At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR
  • Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR
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  • MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks
  • ECOG performance status 0 to 2
  • Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential
  • Available archival tumor specimen suitable for DLL3 IHC or clinician already has plans to obtain tumor specimen as part of standard of care (unrelated to patient participation in 19-292) which will yield sufficient tumor specimen to allow for DLL3 IHC
  • For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET/CT guided biopsy3 as described in section 9.3.
  • Patients with SCLC will be the primary study population, however patients with other types of neuroendocrine tumors may be included at the PI's discretion.
  • Criterion is intended to demonstrate presence of imageable disease. A low-dose CT (e.g. from a PET/CT scan) may be used at PI's discretion.
  • While willingness to undergo the biopsy is required if archival tissue is not available, PET/CT guided biopsy is not a mandatory study assessment. As described in section 9.3, the guided biopsy may be waived at the discretion of the principal investigator if the DLL3 PET/CT reveals no sites of DLL3 tracer-avid tumor or if the principal investigator deems itis not in the best interest of the patient, according to best clinical judgement. The pediatric population would not be approached for an optional PET/CT-guided biopsy
  • Subject Inclusion Criteria for Pediatric population
  • Signed, informed consent
  • Age 4 or more years
  • High risk neuroblastoma patients
  • At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks
  • ECOG performance status 0 to 2
  • Performance Status: Subjects must have a Lansky (<16 years) of at least 40
  • Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential

Who cannot join

  • Subject Exclusion Criteria for the Adult population
  • History of anaphylactic reaction to humanized or human antibodies
  • Pregnant or breast feeding
  • Psychiatric illness that would interfere with compliance with the study procedures
  • Inability to undergo PET scan due to weight limit
  • Patients who require anesthesia or monitored sedation to tolerate PET scan procedure
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  • Subject Exclusion Criteria for the Pediatric population
  • History of anaphylactic reaction to humanized or human antibodies
  • Pregnant or breast feeding
  • Psychiatric illness that would interfere with compliance with the study procedures
  • Inability to undergo PET scan due to weight limit
  • Patients who require anesthesia or monitored sedation to tolerate PET scan procedure

Trial locations and contacts

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

Mark P Dunphy, DO contact

212-639-8131

dunphym@mskcc.org

Charles Rudin, MD, PhD contact

646-888-4527

rudinc@mskcc.org

United States1 site, 1 recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Mark Dunphy, DO, 212-639-8131

    Recruiting

Other trials in United States

About this study

Official title: Immuno-PET Imaging of Neuroendocrine Tumors Using 89Zr-DFO-SC16.56, a DLL3-targeting Monoclonal Antibody

The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer.

Being tested
89Zr-DFO-SC16.56, SC16.56, Phase I, Cohort 2, SC16.56, Phase I, Cohort 3, SC16.56, Phase II
Keywords
Small cell lung cancer, Small Cell Lung Carcinoma, 89Zr-DFO-SC16.56, 19-292, Memorial Sloan Kettering Cancer Center
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • 89Zr-DFO-SC16.56Drug

    Injection of 2 mCi of 89Zr-DFO-SC16.56 for Phase I participants. Dose for Phase II will be determined by results from Phase I.

  • SC16.56, Phase I, Cohort 2Drug

    7.5mg

  • SC16.56, Phase I, Cohort 3Drug

    22.5mg

  • SC16.56, Phase IIDrug

    Dose for Phase II will be determined by results from Phase I.

Study groups in NCT04199741
Study groupRoleWhat they receive
Phase IExperimentalUp to 12 participants with tumors that are found to be >/= 50% positive for DLL3 by IHC
Receives: Drug: 89Zr-DFO-SC16.56; Drug: SC16.56, Phase I, Cohort 2; Drug: SC16.56, Phase I, Cohort 3
Phase IIExperimentalUp to 18 participants with tumors that are found to be >/= 50% positive for DLL3 by IHC
Receives: Drug: 89Zr-DFO-SC16.56; Drug: SC16.56, Phase II

What is being measured

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

  1. Phase I: Radiation Dosimetry of 89Zr- DFO-SC16.56 PET/CT imaging in participants

    The PET and blood data are used to quantify tracer-biodistribution, measuring the amount of radioactivity present in the blood and bodily regions-of-interest

    Measured: Up to 12 months

  2. Phase I: Safety of 89Zr- DFO-SC16.56 PET/CT imaging in cancer patients by evaluating toxicities

    89Zr- DFO-SC16.56 PET/CT will be considered safe if there are no possibly probably, or definitely related grade 3 or higher toxicities (except allergic reactions) among the patients enrolled in the phase I portion

    Measured: up to 12 months

  3. Phase II: Correlation between tumor uptake of 89Zr- DFO-SC16.56 with expression of DLL3

    This is determined by immunohistochemistry and quantitative mass spectrometry.

    Measured: Up to 12 months

Timeline

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

  1. First posted16 Dec 2019
  2. Study start11 Dec 2019
  3. Primary completion11 Jun 2027 (estimated)
  4. Study completion11 Jun 2027 (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 1/2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04199741
Sponsor's protocol ID
19-292
Status last verified
Oct 2026
First submitted
12 Dec 2019
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
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.

Publications

  • Tendler S, Dunphy MP, Agee M, O'Donoghue J, Aly RG, Choudhury NJ, Kesner A, Kirov A, Mauguen A, Baine MK, Schoder H, Weber WA, Rekhtman N, Lyashchenko SK, Bodei L, Morris MJ, Lewis JS, Rudin CM, Poirier JT. Imaging with [89Zr]Zr-DFO-SC16.56 anti-DLL3 antibody in patients with high-grade neuroendocrine tumours of the lung and prostate: a phase 1/2, first-in-human trial. Lancet Oncol. 2024 Aug;25(8):1015-1024. doi: 10.1016/S1470-2045(24)00249-3. Epub 2024 Jun 28.

    PubMed 38950555

  • Tully KM, Tendler S, Carter LM, Sharma SK, Samuels ZV, Mandleywala K, Korsen JA, Delos Reyes AM, Piersigilli A, Travis WD, Sen T, Pillarsetty N, Poirier JT, Rudin CM, Lewis JS. Radioimmunotherapy Targeting Delta-like Ligand 3 in Small Cell Lung Cancer Exhibits Antitumor Efficacy with Low Toxicity. Clin Cancer Res. 2022 Apr 1;28(7):1391-1401. doi: 10.1158/1078-0432.CCR-21-1533.

    PubMed 35046060

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 89Zr-DFO-SC16.56, SC16.56, Phase I, Cohort 2 and SC16.56, Phase I, Cohort 3 in people with Small Cell Lung Cancer and Small Cell Lung Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site 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 22 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Mark P Dunphy, DO (212-639-8131, dunphym@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Radiation Dosimetry of 89Zr- DFO-SC16.56 PET/CT imaging in participants (time frame: Up to 12 months). The study lists 3 primary outcomes in all. 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 NCT04199741, which also lists 2 linked publications.

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 27 Oct 2026.

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