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Extrapulmonary Small Cell Carcinoma and Neuroendocrine CarcinomaPhase 2TAURUSNCT06816394

Tarlatamab for Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma (TAURUS)

A Phase 2 study testing Tarlatamab in people with Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

Extrapulmonary small cell carcinoma (EPSCC) or neuroendocrine carcinoma (NEC) is a rare but fatal disease. The prognosis of patients with advanced EPSCC or NEC failed platinum-etoposide chemotherapy is poor with median overall survival ranged 6 to 9 months. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tarlatamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteTaiwan
Study dates
1 Jan 2026to 30 Apr 2029
Phase
Phase 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

  • Written informed consent.
  • Failed prior platinum-based chemotherapy
  • Histologically proven extrapulmonary small cell carcinoma or neuroendocrine carcinoma from gastrointestinal tract, genitourinary tract, gynecologic origin, and head and neck or unknown primary. When mixed histology (ex, adenocarcinoma, squamous cell carcinoma or transitional carcinoma) is found, small cell carcinoma or neuroendocrine carcinoma should be the predominant part.
  • Measurable lesions by RECIST 1.1 within 28 days prior to the first dose of tarlatamab.
  • ECOG Performance Status (PS) of 0 or 1.
  • Age greater or equal to 18 years old.
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  • Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded [FFPE] sample) or willing to undergo pretreatment tumor biopsy.
  • Subjects with treated brain metastases are eligible provided they meet the following criteria:
  • Definitive therapy was completed at least 2 weeks prior to the first dose of tarlatamab.
  • There is no evidence of radiographic central nervous system (CNS) progression following definitive therapy and by the time of study screening.
  • Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.
  • Adequate organ function, defined as follows:
  • hematological function:
  • absolute neutrophil count ≥ 1.5 x 109/L
  • platelet count ≥ 100 x 109/L
  • hemoglobin > 9 g/dL (90 g/L)
  • coagulation function:
  • prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN). Subjects on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the chief investigator.
  • renal function:
  • estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation > 30 mL/min/1.73 m2.
  • hepatic function:
  • aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) < 3 x ULN (or < 5 x ULN for subjects with liver involvement).
  • total bilirubin < 1.5 x ULN (or < 2 x ULN for subjects with liver metastases).
  • pulmonary function:
  • no clinically significant pleural effusion
  • baseline oxygen saturation > 90% on room air
  • cardiac function: (1) cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) and no clinically significant electrocardiogram (ECG) findings

Who cannot join

  • Uncontrolled brain metastasis and leptomeningeal disease.
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Prior exposure to DLL3 targeting agent.
  • Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
  • Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for > 21 day) which may be allowed.
  • History of other malignancy within the past 2 years, with the following exceptions:
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  • malignancy treated with curative intent and with no known active disease present for > 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
  • adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • adequately treated cervical carcinoma in situ without evidence of disease.
  • adequately treated breast ductal carcinoma in situ without evidence of disease.
  • prostatic intraepithelial neoplasia without evidence of prostate cancer.
  • adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ.
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of tarlatamab.
  • History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.
  • Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose of tarlatamab with the exception:
  • Those who have an active infection requiring parenteral antibiotic treatment: simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile for >24 hours, have no leukocytosis, nor clinical signs of infection are eligible.
  • History of hypophysitis or pituitary dysfunction.
  • Exclusion of hepatitis infection based on the following results and/or criteria:
  • Active hepatitis C infection (subjects with detectable hepatitis C antibody [HCV Ab] and HCV RNA viral load above the limit of quantification)
  • Subjects with presence of HCV Ab and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed.
  • Active hepatitis B infection (presence of hepatitis B surface antigen [HBsAg] and hepatitis B virus [HBV] DNA viral load above the limit of quantification [HBV DNA positive])
  • Subjects with resolved HBV infection defined as absence of HBsAg and presence of HBV core antibody (anti-HBc) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.
  • Subjects with chronic HBV infection inactive carrier state defined as presence of HBsAg and HBV DNA viral load below the limit of quantification [HBV DNA negative] are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.
  • Major surgery within 28 days of first dose tarlatamab.
  • Subject received prior therapy with tarlatamab.
  • Prior anti-cancer therapy within 30 days prior to first dose of tarlatamab.
  • Exceptions:
  • Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade ≤ 1.
  • Prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab.
  • Subjects has a diagnosis of immunodeficiency (e.g., positive/non-negative test for human immunodeficiency virus) except subjects on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study per local or institutional guidelines or subject is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab.
  • The following vaccines (live and live-attenuated vaccines) are excluded during the following study periods:
  • Screening and during study treatment: live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study.
  • Live viral non-replicating vaccine (e.g., Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care and institutional guidelines.
  • End of study treatment: live and live-attenuated vaccines can be used when at least 60 days (5 x half-life of tarlatamab) have passed after the last dose of tarlatamab.
  • Subjects unwilling to use contraception or practice abstinence during treatment and for an additional 60 days after the last dose of tarlatamab.
  • Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.
  • Male subjects unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.
  • Female subjects planning to become pregnant while on study through 60 days after the last dose of tarlatamab.
  • Female subjects of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or serum pregnancy test.
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Trial locations and contacts

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

Jhe-Cyuan Guo contact

+886-223220322 ext. 238039

jhecyuanguo@gmail.com

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital

    Taipei, Please Select, 100056

    Jhe-Cyuan Guo, +886-223220322 ext. 238039, jhecyuanguo@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Tarlatamab for Patients With Previously Treated Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma

Extrapulmonary small cell carcinoma (EPSCC) or neuroendocrine carcinoma (NEC) is a rare but fatal disease. The prognosis of patients with advanced EPSCC or NEC failed platinum-etoposide chemotherapy is poor with median overall survival ranged 6 to 9 months. High expression levels of DLL3 has been demonstrated in many EPSCC or NEC. As tarlatamab, a bispecific T-cell engager with dual affinity for DLL3 on tumor cells and CD3 on T cells, has demonstrated clinically meaningful activity for patients with advanced small cell lung cancer. We thus hypothesize that tarlatamab also has clinically activity for patients with advanced EPSCC and NECs.

Being tested
Tarlatamab
Keywords
tarlatamab, extrapulmonary small cell carcinoma, neuroendocrine carcinoma
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

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

  • TarlatamabDrug

    All subjects will receive a step dose (1 mg tarlatamab) on cycle 1 day 1 administered as a 60-minute intravenous (IV) infusion then 10 mg tarlatamab IV administered on cycle 1 day 8, cycle 1 day 15, and every 2 weeks (Q2W) thereafter.

Study groups in NCT06816394
Study groupRoleWhat they receive
TarlatamabExperimentalNot described
Receives: Drug: Tarlatamab

What is being measured

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

  1. Objective response rate (ORR) per RECIST 1.1 by investigator

    Measured: From enrollment to the end of treatment at 8 weeks

Timeline

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

  1. First posted10 Feb 2025
  2. Study start1 Jan 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Apr 2029 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06816394
Sponsor's protocol ID
202412002MIFE
Other IDs
20247089
Acronym
TAURUS
Status last verified
Sep 2026
First submitted
4 Feb 2025
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tarlatamab in people with Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.

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 27 inclusion and 42 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 17 Sep 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 Taiwan. 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 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 Jhe-Cyuan Guo (+886-223220322 ext. 238039, jhecyuanguo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) per RECIST 1.1 by investigator (time frame: From enrollment to the end of treatment at 8 weeks). 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 NCT06816394.

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 17 Sep 2026.

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