Recruiting

RAGNARTarlatamab with Chemotherapy in Advanced Neuroendocrine Carcinomas

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Study Aim

This study is for people with advanced neuroendocrine carcinomas, aiming to test if the drug Tarlatamab, when used with chemotherapy, can help improve progression-free survival and overall survival.

What is being tested

Tarlatamab

+ standard of care second-line chemotherapy (FOLFIRI)

Drug
Who is being recruted

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorGrupo Espanol de Tumores Neuroendocrinos
Study ContactFederico Nepote, M.D., PhD.More contacts
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 18, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on advanced neuroendocrine carcinomas (NECs) of the digestive system or unknown primary origin, which are aggressive cancers that are difficult to treat. These tumors are quite rare, but their detection has increased thanks to better diagnostic tools. Currently, the main treatment for these tumors is chemotherapy, but it only provides limited benefits. The study explores whether tarlatamab, a drug that targets specific tumor markers, either alone or with a standard chemotherapy called FOLFIRI, can offer better outcomes for patients. The ultimate goal is to find an effective treatment option that could improve survival and quality of life for those affected by these challenging cancers. In this trial, participants are divided into two groups: one receives only tarlatamab, while the other receives tarlatamab along with FOLFIRI chemotherapy. The trial evaluates how long patients live without the cancer progressing and their overall survival over a year. Safety and potential side effects are closely monitored, with adjustments made to ensure participants' well-being. Regular imaging tests like CT or MRI scans assess the cancer's response to the treatment. Approximately 87 patients from hospitals in Spain and France will participate, and their quality of life is also evaluated throughout the study to ensure a comprehensive understanding of the treatment's impact.

Official TitlePhase II Study Of Tarlatamab Alone Or In Combination With Chemotherapy In Advanced Neuroendocrine Carcinomas Of The Digestive System Or Unknown Primary Origin
NCT07061080
Principal SponsorGrupo Espanol de Tumores Neuroendocrinos
Study ContactFederico Nepote, M.D., PhD.More contacts
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

87 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

11 inclusion criteria required to participate
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.

Patient is ≥ 18 years of age.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Histologically confirmed neuroendocrine carcinomas (NECs) of the digestive system or unknown primary origin. Note: Carcinomas of pulmonary origin are not eligible.

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7 exclusion criteria prevent from participating
The following endocrine tumor types may not be included: Paraganglioma, adrenal, thyroid parathyroid or pituitary endocrine tumors, Large or small cell lung neuroendocrine carcinoma of the lung, Neuroendocrine tumors (NETs) of the gastrointestinal tract or unknown origin (i.e. well differentiated tumors)

Major surgery within 28 days of first dose tarlatamab.

History of solid organ transplantation.

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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Tarlatamab as intravenous infusion at 10mg in combination with the standard of care second-line chemotherapy (FOLFIRI)

Group II

Active Comparator
Tarlatamab as a standalone treatment through intravenous infusion at 10 mg dose every 14 days (i.e. 2 weeks).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Recruiting

H.U. Vall d'Hebron

Barcelona, SpainOpen H.U. Vall d'Hebron in Google Maps
Recruiting soon

Brest University Hospital Centre

Brest, France
Recruiting soon

Centre Régional de Lutte Contre le Cancer Institut Bergonié (Bordeaux)

Bordeaux, France
Recruiting soon

Centre Oscar Lambret

Lille, France
Recruiting
19 Study Centers