Diagnosis of Neuro-endocrine Carcinoma of the Gynecological TractPhase 2TARGETNCT07788365
Tarlatamab in Recurrent Gynecological Neuroendocrine Carcinomas: A Phase II Proof-of-concept Study
A Phase 2 study testing Tarlatamab treatment in people with Diagnosis of Neuro-endocrine Carcinoma of the Gynecological Tract, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Neuroendocrine carcinoma of the cervix (NECC) is an aggressive histological variant of cervical cancer accounting for about 1-1.5% of all cervical cancers. Small cell NEC is the most common type of NECC. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diagnosis of Neuro-endocrine Carcinoma of the Gynecological Tract
- What is being tested?
- Tarlatamab treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2027to 31 Aug 2030
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2.
- A confirmed diagnosis of neuro-endocrine carcinoma of the gynecological tract including small cell cervical cancer or other high-grade neuro-endocrine carcinoma from the vulva or vagina. Mixed histologies are allowed only if the neuro-endocrine carcinoma component is predominant
- Previously been treated with platinum-based doublet chemotherapy, either in the locally-advanced or recurrent or metastatic setting. Prior treatment with an immune-checkpoint inhibitor is allowed.
- Progressed radiographically on or after their most recent line of anticancer therapy
- At least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
- Patients must be willing to provide an archival tumor tissue block or slides, or undergo a procedure to obtain a new biopsy using a low-risk, medically routine procedure for translational analysis only (including DLL3 expression determination). Subjects who do not have archived tumor tissue available and who are unable to undergo a pretreatment tumor biopsy (e.g. cannot be performed safely or if the tumor is inaccessible, as determined by the study investigator) may be allowed to enroll without a tumor biopsy upon agreement between the local investigator and the coordinating investigator.
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- Completed prior therapy within the specified times below:
- Systemic antineoplastic therapy within 2 weeks prior to first dose of Tarlatamab
- Focal radiation completed at least 1 week prior to first dose of Tarlatamab
- Stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia and neuropathy)
- Adequate hematologic, liver and kidney functions defined as:
- Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (1000/μL)
- Platelet count ≥ 75 x 109/L (75 000/μL)
- Hemoglobin ≥ 9.0 g/dL
- Estimated glomerular filtration rate (eGFR) based on CKD-EPI calculation ≥ 30 mL/min/1.73 m2
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
- Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN)
- Serum albumin ≥ 25 g/L
- No significant pleural effusion
- Cardiac ejection fraction ≥ 50% as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, no clinically significant pericardial, and no clinically significant electrocardiogram (ECG) findings (including but not limited to: signs of recent ischemia, high grade conduction abnormalities, QTcF>500ms)
- Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements
- Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on Tarlatamab and for at least 2 months after the last dose
- WCBP must have a negative pregnancy test within the 4 days prior to the first dose of Tarlatamab
- Affiliated to a social health insurance plan
Who cannot join
- 1. Non-neuroendocrine histologies (e.g. adenocarcinoma, epidermoid carcinoma). 2. Well-differentiated NETs, especially NET G1 (typical carcinoid) and NET G2 (atypical carcinoid) 3. Neuro-endocrine carcinoma arising from the endometrium or ovaries or fallopian tubes.
- 4. Treated with more than 2 previous lines of systemic therapy for the metastatic disease.
- 5. Prior ICI-treatment is allowed, but patients who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions, including those that lead to permanent discontinuation while on treatment, are excluded.
- 6. Untreated or symptomatic brain metastases and leptomeningeal disease. 7. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- 8. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Tarlatamab.
- 9. Has a serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
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- Active hepatitis B or C infection (whether or not on active antiviral therapy)
- HIV infection
- Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose of Tarlatamab.
- NOTE: Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the coordinating investigator. Subjects requiring oral antibiotics who have been afebrile > 24 hours, have no leukocytosis or have any clinical signs of infection are eligible.
- 10. History of other malignancy within the past 3 years, unless it will not interfere with the disease under study.
- 11. Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of Tarlatamab 12. History of hypophysitis or pituitary dysfunction 13. Major surgery within 28 days of first dose Tarlatamab 14. Has a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment 15. Has a history of cirrhotic liver disease (Child-Pugh Class B or C) 16. Has a history of prior hypersensitivity to monoclonal antibodies (mAb) 17. Women who are pregnant or breastfeeding 18. Who received prior treatment with Tarlatamab or other DLL3-targeting agents 19. Has known sensitivity to any of the products or components to be administered during dosing. (i.e allergy to Tarlatamab or any ingredient used in the formulation of the products) 20. History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator would be a risk to the subject's safety or interfere with the study evaluation, procedures, or completion.
- 21. Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines and live viral non-replicating vaccines within 4 weeks prior to first dose of study treatment 22. Receiving government medical aid (Aide Médicale de l'Etat - AME) 23. Subject unable to give informed consent (e.g subject to a legal protection measure: curatorship, guardianship, future protection mandate …)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Lauriane EBERST, MD, 0388115266
About this study
Neuroendocrine carcinoma of the cervix (NECC) is an aggressive histological variant of cervical cancer accounting for about 1-1.5% of all cervical cancers. Small cell NEC is the most common type of NECC. This malignancy is induced by the human papillomavirus, like the other more common cervical cancers subtypes (i.e squamous cervical cancer and adenocarcinoma), but has a far worse prognosis. Local and distant relapses occur more often in NECC, and the 5-year overall survival (OS) is significantly poorer with around 30% (compared to > 65% for the others). Thus, the aggressive nature of NECC resembles that of small cell lung cancer (SCLC), which, at the time of initial diagnosis, is mostly locally advanced or metastasized.
The Gynecologic Cancer InterGroup recommends a multimodal approach for advanced disease, with chemoradiation or systemic chemotherapy consisting of etoposide and cisplatin. There is no standard of care in case of recurrence after platinium-based chemotherapy. Retrospective data suggests the combination of Paclitaxel, Topotecan, and Bevacizumab1, but median progression-free-survival (PFS) was only 8,7 months and median OS 16.8 months with this regimen in the NECTuR retrospective register (starting from the initiation of therapy for recurrence).
Read more
Tarlatamab is a bispecific T-cell engager immunotherapy (BiTE). It binds to both DLL3 on cancer cells and to CD3 on T cells, leading to T-cell-mediated lysis of cancer cells. DLL3, a protein that inhibits Notch signaling, is overexpressed on the surface of SCLC. It is associated with OS benefit in pre-treated SCLC in the randomized phase 3 DeLLphi-304 trial (Mountzios et al). Recently, it has been confirmed that high DLL3 expression is associated with high-grade neuroendocrine features, making it a promising therapeutic target beyond SCLC. Interestingly, gynecological neuro-endocrine neoplasias were classified as DLL3-high expressing tumors with whole-transcriptome sequencing analysis (Lozano et al).
Given the biological similarities between SCLC and NECC, and the high expression of DLL3, Tarlatamab should also be evaluated in gynecological NEC.
- Being tested
- Tarlatamab treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tarlatamab treatmentDrug
Tarlatamab will be administered as an IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Tarlatamab | Experimental | Not described Receives: Drug: Tarlatamab treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) at month 9, defined as the time from first administration of Tarlatamab to progression
Measured: at 9 months
Overall Survival (OS)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start15 Jan 2027 (estimated)
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis of Neuro-endocrine Carcinoma of the Gynecological TractStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788365
- Sponsor's protocol ID
- 9881
- Acronym
- TARGET
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tarlatamab in Recurrent Gynecological Neuroendocrine Carcinomas: A Phase II Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT07788365
- Acronym / sponsor ID
- TARGET / 9881
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuroendocrine carcinoma of the cervix (NECC) is an aggressive histological variant of cervical cancer accounting for about 1-1.5% of all cervical cancers. Small cell NEC is the most common type of NECC. This malignancy is induced by the human papillomavirus, like the other more common cervical cancers subtypes (i.e squamous cervical cancer and adenocarcinoma), but has a far worse prognosis. Local and distant relapses occur more often in NECC, and the 5-year overall survival (OS) is significantly poorer with around 30% (compared to > 65% for the others). Thus, the aggressive nature of NECC resembles that of small cell lung cancer (SCLC), which, at the time of initial diagnosis, is mostly locally advanced or metastasized.
The Gynecologic Cancer InterGroup recommends a multimodal approach for advanced disease, with chemoradiation or systemic chemotherapy consisting of etoposide and cisplatin. There is no standard of care in case of recurrence after platinium-based chemotherapy. Retrospective data suggests the combination of Paclitaxel, Topotecan, and Bevacizumab1, but median progression-free-survival (PFS) was only 8,7 months and median OS 16.8 months with this regimen in the NECTuR retrospective register (starting from the initiation of therapy for recurrence).
Tarlatamab is a bispecific T-cell engager immunotherapy (BiTE). It binds to both DLL3 on cancer cells and to CD3 on T cells, leading to T-cell-mediated lysis of cancer cells. DLL3, a protein that inhibits Notch signaling, is overexpressed on the surface of SCLC. It is associated with OS benefit in pre-treated SCLC in the randomized phase 3 DeLLphi-304 trial (Mountzios et al). Recently, it has been confirmed that high DLL3 expression is associated with high-grade neuroendocrine features, making it a promising therapeutic target beyond SCLC. Interestingly, gynecological neuro-endocrine neoplasias were classified as DLL3-high expressing tumors with whole-transcriptome sequencing analysis (Lozano et al).
Given the biological similarities between SCLC and NECC, and the high expression of DLL3, Tarlatamab should also be evaluated in gynecological NEC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tarlatamab | Experimental | Drug: Tarlatamab treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- An Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2.
- A confirmed diagnosis of neuro-endocrine carcinoma of the gynecological tract including small cell cervical cancer or other high-grade neuro-endocrine carcinoma from the vulva or vagina. Mixed histologies are allowed only if the neuro-endocrine carcinoma component is predominant
- Previously been treated with platinum-based doublet chemotherapy, either in the locally-advanced or recurrent or metastatic setting. Prior treatment with an immune-checkpoint inhibitor is allowed.
- Progressed radiographically on or after their most recent line of anticancer therapy
- At least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
Key exclusion criteria (13 listed)
- 1. Non-neuroendocrine histologies (e.g. adenocarcinoma, epidermoid carcinoma). 2. Well-differentiated NETs, especially NET G1 (typical carcinoid) and NET G2 (atypical carcinoid) 3. Neuro-endocrine carcinoma arising from the endometrium or ovaries or fallopian tubes.
- 4. Treated with more than 2 previous lines of systemic therapy for the metastatic disease.
- 5. Prior ICI-treatment is allowed, but patients who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions, including those that lead to permanent discontinuation while on treatment, are excluded.
- 6. Untreated or symptomatic brain metastases and leptomeningeal disease. 7. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- 8. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Tarlatamab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tarlatamab treatmentTarlatamab will be administered as an IV infusion | Drug | Tarlatamab |
Primary outcome
Progression free survival (PFS) at month 9, defined as the time from first administration of Tarlatamab to progression
Time frame: at 9 months
Overall Survival (OS)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tarlatamab treatment in people with Diagnosis of Neuro-endocrine Carcinoma of the Gynecological Tract, run by University Hospital, Strasbourg, France at 1 site in France.
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 24 inclusion and 13 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 26 Aug 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 France. 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 Lauriane EBERST, MD (03 68 76 71 68 ext. 0033, lauriane.eberst@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) at month 9, defined as the time from first administration of Tarlatamab to progression (time frame: at 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.