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Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)

A GCO Trial Exploring the Efficacy and Safety of Tarlatamab Versus Investigator-choice Chemotherapy in Pre-treated Patients With Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)

NCT06937905•Intergroupe Francophone de Cancerologie Thoracique

View on ClinicalTrials.gov

Summary

Based on the efficacy of tarlatamab in patients with small-cell lung cancer, we aim to assess the efficacy of tarlatamab in patients with Advanced, pulmonary (large-cell only) or gastroenteropancreatic neuroendocrine carcinoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed Informed consent:
•* Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
•* Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing
•2. Age ≥ 18 years.
•3. WHO Performance status 0 - 1.
•4. Life expectancy \> 12 weeks.
•5. Histologically proven and centrally confirmed poorly differentiated neuroendocrine carcinoma (NEC): large cells for lung NEC (WHO 2015 classification), and large and small cells for extra-gastroenteropancreatic (assessed on archived tissue, with possible pre-screening during first-line).
•6. Expression of DLL3 in at least 1% of tumor cells (assessed on archived tissue, with possible pre-screening during first-line)
•7. Tumor progression following one platinum based line of therapy.
•8. Unresectable locally advanced or metastatic stage.
+31 more criteria

Exclusion Criteria

•1. Well-differentiated neuroendocrine tumor (NET G1, G2 and G3 according to digestive WHO 2017 classification or typical/atypical carcinoid tumor according to lung WHO 2015 classification)
•2. Previous treatment targeting DLL3
•3. More than one line of systemic therapy in the metastatic setting. Chemotherapy for non-metastatic stage is not considered as first-line if there is a time interval of at least 6 months between the last dose of chemotherapy for non-metastatic stage and the initiation of first-line chemotherapy for metastatic/recurrent disease.
•4. Small cell lung NEC (except as a minor \<30% component in mixed tumors)
•5. Known EGFR activating mutation or ALK or ROS1 rearrangement for lung NEC
•6. Untreated or symptomatic central nervous system (CNS) metastases:

Locations (40)

Angers - CHU

Angers, France

Avignon - CH

Avignon, France

Besançon - CHU

Besançon, France

Boulogne - Ambroise Paré

Boulogne, France

Caen - CHU

Caen, France

Caen - CHU

Caen, France

Tours - CHU

Chambray-lès-Tours, France

Dijon - Centre Georges-François Leclerc

Dijon, France

Dijon - CHU Bocage

Dijon, France

Grenoble - CHU

Grenoble, France

Key Dates

Start Date

February 6, 2026

Primary Completion Date

February 1, 2029

Completion Date

August 1, 2030

Last Updated

February 11, 2026

Enrollment

129

ESTIMATED participants

Conditions

Neuroendocrine Carcinoma

Interventions

Standard of Care Chemotherapy

DRUG

Tarlatamab

DRUG

Contacts

Contact IFCT

CONTACT

+33 1.56.81.10.45 contact@ifct.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)

Inclusion Criteria

Exclusion Criteria

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