RecruitingPhase 2NCT06393816

FIRST-NEC (GFPC 01-2022) - Combination of Durvalumab With Etoposide and Platinum

A Multicenter Phase II Study Evaluating the Efficacy and Safety of the Combination of Durvalumab With Etoposide and Platinum as First Line Treatment in Patients With Large-cell Neuroendocrine Carcinomas (LCNECs) of the Lung

Sponsor

Centre Leon Berard

Enrollment

80 participants

Start Date

Jun 13, 2024

Study Type

INTERVENTIONAL

Conditions

Large Cell Neuroendocrine Carcinoma of the Lung

Summary

The primary objective is to determine the efficacy (Progression-Free Rate at 12 months) of durvalumab combined with etoposide and platinum (either cisplatin or carboplatin) for the first-line treatment of patients with advanced LCNEC confirmed by centralized expert-pathologist review

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding durvalumab (an immunotherapy) to standard chemotherapy (etoposide and platinum) improves outcomes as a first-line treatment for large-cell neuroendocrine carcinoma of the lung (LCNEC) — a rare and aggressive type of lung cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with large-cell neuroendocrine carcinoma of the lung (LCNEC), confirmed by central pathology review - Your cancer is locally advanced (Stage III, not suitable for local treatment) or has spread to other parts of the body (Stage IV) and has not been treated yet - You are in good general health (ECOG performance score 0 or 1) - You weigh more than 30 kg - You have at least 12 weeks of expected survival **You may NOT be eligible if...** - You have received prior systemic treatment for LCNEC - You have active autoimmune disease or are receiving immune-suppressing medications - You have brain metastases that are active or untreated 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

DRUGDurvalumab with etoposide and Carboplatin/Cisplatin

Combination of durvalumab with etoposide and Carboplatin/Cisplatin as First Line Treatment in Patients With Large-cell Neuroendocrine Carcinomas of the Lung. All patients (either with confirmed diagnosis or not) will be treated and followed-up: * During the induction: every 3 weeks for 12 weeks (4 cycles) * During the maintenance: every 4 weeks for 24 months

Locations(31)

Centre Hospitalier Intercommunal Aix-Pertuis

Aix-en-Provence, France

Chu Amiens Picardie Site Sud

Amiens, France

Chu Angers

Angers, France

CENTRE HOSPITALIER d'AVIGNON

Avignon, France

CHU BREST Cavale Blanche

Brest, France

Centre Francois Baclesse

Caen, France

Chu Gabriel Montpied

Clermont-Ferrand, France

Centre Hospitalier Intercommunal de Creteil

Créteil, France

Chu Annecy Genevois

Épagny, France

Chu Grenoble Alpes

Grenoble, France

Centre Oscar Lambret

Lille, France

Chu Dupuytren

Limoges, France

Groupe Hospitalier Bretagne Sud

Lorient, France

Centre Leon Berard

Lyon, France

APHM, hôpital nord

Marseille, France

Grand Hopital de L'Est Francilien - Site de Meaux

Meaux, France

GHRMSA, hôpital Emile Muller

Mulhouse, France

CHU NICE

Nice, France

Hopital Cochin

Paris, France

Hopital Tenon

Paris, France

Centre Francois Magendie

Pessac, France

Hospices Civils de Lyon - Lyon Sud Hospital

Pierre-Bénite, France

Centre Hospitalier de Cornouaille

Quimper, France

CHU Rennes

Rennes, France

Institut de Cancerologie Strasbourg Europe

Strasbourg, France

Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil

Strasbourg, France

Hopital Foch

Suresnes, France

Hia Saint Anne

Toulon, France

Chu Toulouse

Toulouse, France

Hopital Nord Ouest de Villefranche Sur Saone

Villefranche-sur-Saône, France

Chu Reunion

Réunion, Reunion

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NCT06393816

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