Modern Trials

Clinical Trials

NCT Id	NCT04108026
Title	Immunotherapy in Patient With Poor General Condition
Condition	Non-small Cell Lung Cancer Stage IV
StudyType	Interventional
Organization	Intergroupe Francophone de Cancerologie Thoracique
Sponsor/Collaborators	Intergroupe Francophone de Cancerologie Thoracique
Status	Recruiting
Gender	All
AgeGroup	Adult Older Adult
Location (with distance)	Besançon - CHU, Besançon, France Hôpital Ambroise Paré - Pneumologie, Boulogne, France Caen - CHU Côte de Nacre, Caen, 14000 , France CH, Colmar, France CHRU Grenoble, Grenoble, France Centre Hospitalier - Pneumologie, Le Mans, 72000 , France CHRU de Lille, Lille, France AP-HM Hopital Nord, Marseille, France Montpellier - CHRU, Montpellier, 34295 , France GRH Mulhouse Sud-Alsace, Mulhouse, France Nancy - Institut de Cancérologie de Lorraine, Nancy, France Nantes - ICO Site René Gauducheau, Nantes, 44805 , France CHR d'Orléans La Source, Orléans, France AP-HP Hopital Tenon - Pneumologie, Paris, 75020 , France Paris - APHP Bichat, Paris, France Paris - Curie, Paris, France Lyon - URCOT, Pierre-Bénite, France CHU Strasbourg, Strasbourg, France CHU Toulouse - Pneumologie, Toulouse, France CHU Tours - Pneumologie, Tours, France
Description	Immunotherapeutic approaches targeting immune checkpoint proteins PD-1/PD-L1 have recently demonstrated clinical efficacy in several cancer types, and have changed the therapeutic landscape in metastatic melanoma or non-small cell lung cancer (NSCLC). The monoclonal anti-PD-1 antibody nivolumab has been registered by both FDA (Food and Drug Administration) and EMA (European Medicine Agency), for metastatic NSCLC patients, after failure of a prior platinum-based chemotherapy. The approval was based on the results of phase III clinical trials in metastatic NSCLC. But all the trials only enrolled patients with good general condition, PS (Performance Status) 0 or 1. However, the prevalence of poor PS patients at time of diagnosis is high in lung cancer patients. For patients with metastatic NSCLC and PS 3, there is no standard treatment except best supportive care, since all trials that accrued unselected PS 3 patients fail to prove any survival advantage, and most PS >3 patients die within 2 to 4 months from diagnosis. Indeed, these patients are currently excluded from clinical trials. Specific dedicated clinical trials and treatment guidelines for this patient population are urgently needed, taking into account for the high prevalence of such patients.