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Brief Title: Immune Neoadjuvant Therapy Study of Durvalumab in Early Stage Non-small Cell Lung Cancer
Official Title: A Phase II Prospective Immune Neoadjuvant Therapy Study od Durvalumab (MEDI4736) in Early Stage Non-small Cell Lung Cancer
Study ID: NCT03030131
Brief Summary: Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA) NSCLC is curative surgery. Although patients treated with curative surgery have a better prognosis, the 5-year survival for patients treated with surgery alone remains low, ranging from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing postoperative chemotherapy versus no chemotherapy have shown a significant overall survival benefit from postoperative chemotherapy in completely resected patients with NSCLC stage II and IIIA. Likewise other randomized trials have demonstrated preoperative chemotherapy improves survival and recently the analyses also based on individual patients data of 15 randomized trials showed a significant benefit of preoperative chemotherapy on survival with the same survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also become accepted in many countries. Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an attractive therapeutic option in the early stage NSCLC, which may reactivate host immune responses and enable longterm tumor control.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Amiens - Clinique de l'Europe, Amiens, , France
Argenteuil - CH, Argenteuil, , France
Bayonne - CH, Bayonne, , France
Bordeaux - Institut Bergonié, Bordeaux, , France
Caen - CHU, Caen, , France
Caen - CRLCC, Caen, , France
Chauny - CH, Chauny, , France
Clermont-Ferrand - CHU, Clermont-Ferrand, , France
Cornebarrieu - Clinique des Cèdres, Cornebarrieu, , France
Grenoble - CHU, Grenoble, , France
Le Mans - CHG, Le Mans, , France
Limoges - CHU, Limoges, , France
Mantes La Jolie - CH, Mantes La Jolie, , France
AP-HM Hopital Nord, Marseille, , France
Marseille - Hôpital Européen, Marseille, , France
Metz - Hôpital Robert Schuman, Metz, , France
Mulhouse - CH, Mulhouse, , France
Nancy - Polyclinique Gentilly, Nancy, , France
Nantes - CRLCC, Nantes, , France
Paris - Hopital Tenon, Paris, , France
Paris - HEGP, Paris, , France
Paris - Hôpital Cochin, Paris, , France
Paris - Montsouris, Paris, , France
Paris - Saint Joseph, Paris, , France
Paris Bichat, Paris, , France
Pau - CHG, Pau, , France
Centre René Huguenin, Saint-Cloud, , France
Institut de Cancérologie de l'Ouest - site René Gauducheau, Saint-Herblain, , France
Saint-Quentin - CH, Saint-Quentin, , France
Strasbourg - NHC, Strasbourg, , France
Toulouse - CHU Larrey, Toulouse, , France