Clinical Trials

NCT IdNCT04108026
TitleImmunotherapy in Patient With Poor General Condition
ConditionNon-small Cell Lung Cancer Stage IV
StudyTypeInterventional
OrganizationIntergroupe Francophone de Cancerologie Thoracique
Sponsor/CollaboratorsIntergroupe Francophone de Cancerologie Thoracique
StatusNot yet recruiting
GenderAll
AgeGroupAdult
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
DescriptionImmunotherapeutic 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.