RecruitingPhase 3NCT06937905

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)

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Enrollment

129 participants

Start Date

Feb 6, 2026

Study Type

INTERVENTIONAL

Conditions

Neuroendocrine Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new targeted therapy called tarlatamab against standard chemotherapy for people with a rare and aggressive type of cancer called poorly differentiated neuroendocrine carcinoma (NEC), found in the lungs or digestive system. Tarlatamab is a bispecific antibody that helps immune cells find and kill cancer cells. **You may be eligible if...** - You are 18 or older with confirmed poorly differentiated neuroendocrine carcinoma (NEC) of the lung or digestive system - Your tumor has the DLL3 protein present in at least 1% of cells - Your cancer has progressed after one round of platinum-based chemotherapy - Your cancer is unresectable (cannot be removed surgically) or has spread - You are in good general health with adequate organ function **You may NOT be eligible if...** - Your tumor does not have the DLL3 protein marker - You have well-differentiated neuroendocrine tumors (NETs) rather than poorly differentiated NECs - Your organ function (kidneys, blood counts, liver) is significantly impaired - You have already received multiple prior lines of treatment beyond one platinum-based regimen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGStandard of Care Chemotherapy

Study treatment in the arm A is left to the investigator appreciations. This may include immune checkpoint inhibitors, docetaxel, topotecan for primary lung tumors, and FOLFOX, FOLFIRI or alkylating-based chemotherapy in primary digestive tumors.

DRUGTarlatamab

Tarlatamab 10 mg every 2 weeks

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

Le Mans - CHG

Le Mans, France

Lille - Centre Oscar Lambret

Lille, France

Limoges - CHU

Limoges, France

Limoges - CHU

Limoges, France

Lyon - Centre Léon Bérard

Lyon, France

Lyon - Hôpital Edouard Herriot

Lyon, France

Lyon - Hôpital Privé Jean Mermoz

Lyon, France

Marseille - APHM

Marseille, France

Marseille - Institut Paoli-Calmettes

Marseille, France

Montpellier - CHU

Montpellier, France

Nice - Centre Antoine Lacassagne

Nice, France

Paris - Curie

Paris, France

Paris - Hôpital Cochin

Paris, France

Paris - Saint-Antoine

Paris, France

Paris - Tenon

Paris, France

Bordeaux - CHU

Pessac, France

Bordeaux - CHU

Pessac, France

Lyon - HCL

Pierre-Bénite, France

Poitiers - CHU

Poitiers, France

Reims - CHU

Reims, France

Rennes - CHU

Rennes, France

Rouen - CHU

Rouen, France

Nantes - Hôpital Laennec

Saint-Herblain, France

Nantes - Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Strasbourg - Nouvel Hôpital Civil

Strasbourg, France

Toulon - CHI

Toulon, France

Toulouse - CHU

Toulouse, France

Tours - CHU

Tours, France

Vandoeuvre-lès-Nancy - Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Villefranche sur Saône - CH

Villefranche-sur-Saône, France

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NCT06937905

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