Can a lung cancer drug tackle a rare, aggressive gynecological cancer?

NCT ID NCT07788365

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This phase II trial is testing whether tarlatamab, an immunotherapy drug already used for small cell lung cancer, can help people with recurrent gynecological neuroendocrine carcinoma—a rare and aggressive cancer of the cervix, vulva, or vagina. The drug works by guiding the body's immune T cells to attack cancer cells that carry a specific protein called DLL3, which is common in these tumors. The study will enroll about 20 participants who have already received platinum-based chemotherapy and will measure how long they live without the cancer progressing, as well as overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tarlatamab, an immunotherapy drug given by IV infusion that helps the immune system attack cancer cells
What this could lead to
If it works, tarlatamab could offer a new treatment option for a rare, aggressive cancer that currently has no standard therapy after recurrence.
What could go wrong
This is a small, early-phase study, so results may not apply broadly. Tarlatamab can cause side effects, including immune-related reactions, and may not be effective for all participants.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2. 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 3. 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. 4. Progressed radiographically on or after their most recent line of anticancer therapy 5. At least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator) 6. 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. 7. 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 8. Stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia and neuropathy) 9. 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 10. No significant pleural effusion 11. 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) 12. Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements 13. 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 14. WCBP must have a negative pregnancy test within the 4 days prior to the first dose of Tarlatamab 15. Affiliated to a social health insurance plan Exclusion Criteria: * 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: * 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 …)

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Contacts and locations

Locations

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091, France