De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

1,360

Participants

Timeline

Start Date

May 2, 2022

Primary Completion Date

May 31, 2025

Study Completion Date

June 1, 2029

Conditions
Metastatic NSCLC
Interventions
DRUG

Pembrolizumab before randomization

Pembrolizumab 200 mg every 3 weeks before randomization

DRUG

Chemotherapy

Platinum doublet - 4 cycles: either paclitaxel-carboplatin for patient with SCC or pemetrexed-platinum salt followed by 2 cycles of pemetrexed until reaching the 6 months time-point for randomization Carboplatin AUC 5 for non-squamous cell carcinoma and AUC6 for squamous cell carcinoma every 3 weeks or cisplatin 75 mg/m² every 3 weeks Pemetrexed 500 mg/m² every 3 weeks or paclitaxel 175 mg/m² every 3 weeks

DRUG

Pemetrexed

Maintenance pemetrexed after randomization Pemetrexed 500 mg/m² every 3 weeks

DRUG

Pembrolizumab after randomization

Pembrolizumab 200 mg every 3 weeks after randomization

Trial Locations (44)

14000

RECRUITING

Caen - CHU Côte de Nacre, Caen

31059

NOT_YET_RECRUITING

Hôpital Larrey (CHU), Toulouse

34295

NOT_YET_RECRUITING

Hôpital Arnaud de Villeneuve, Montpellier

42000

NOT_YET_RECRUITING

CHU Saint-Etienne Pneumologie, Saint-Etienne

44805

NOT_YET_RECRUITING

Institut de Cancérologie de l'Ouest - René Gauducheau, Saint-Herblain

54511

NOT_YET_RECRUITING

Centre Alexis Vautrin, Vandœuvre-lès-Nancy

67091

NOT_YET_RECRUITING

Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg, Strasbourg

68070

NOT_YET_RECRUITING

Centre Hospitalier, Mulhouse

72000

NOT_YET_RECRUITING

Centre Hospitalier - Pneumologie, Le Mans

75020

ACTIVE_NOT_RECRUITING

Paris - APHP - Hopital Tenon, Paris

75248

NOT_YET_RECRUITING

Institut CURIE, Paris

85925

NOT_YET_RECRUITING

La Roche Sur Yon - CH, La Roche-sur-Yon

92210

NOT_YET_RECRUITING

Centre René Huguenin, Saint-Cloud

97448

NOT_YET_RECRUITING

CHU de La Réunion-Site Sud, Saint-Pierre

Unknown

NOT_YET_RECRUITING

Aix-en-Provence - CH, Aix-en-Provence

NOT_YET_RECRUITING

Amiens - Clinique de l'Europe, Amiens

NOT_YET_RECRUITING

Angers - CHU, Angers

NOT_YET_RECRUITING

Avignon - CH, Avignon

NOT_YET_RECRUITING

Besançon - CHU, Besançon

NOT_YET_RECRUITING

Bordeaux - Polyclinique, Bordeaux

NOT_YET_RECRUITING

CHU de Bordeaux, Bordeaux

NOT_YET_RECRUITING

Cannes - CH, Cannes

NOT_YET_RECRUITING

Chauny - Centre Hospitalier, Chauny

NOT_YET_RECRUITING

CH, Colmar

NOT_YET_RECRUITING

Centre Georges François Leclerc, Dijon

ACTIVE_NOT_RECRUITING

CHRU Grenoble, Grenoble

NOT_YET_RECRUITING

CH de Versailles, Le Chesnay

NOT_YET_RECRUITING

CHRU de Lille, Lille

NOT_YET_RECRUITING

CHU de Limoges, Limoges

NOT_YET_RECRUITING

Lyon - Hôpital Jean Mermoz, Lyon

NOT_YET_RECRUITING

Marseille - Hôpital Européen, Marseille

NOT_YET_RECRUITING

Meaux - CH, Meaux

ACTIVE_NOT_RECRUITING

Metz - Hôpital Robert Schuman, Metz

NOT_YET_RECRUITING

Nantes - CHU Hôpital Laënnec, Nantes

NOT_YET_RECRUITING

Nice - CRLCC, Nice

NOT_YET_RECRUITING

Orléans - CHR, Orléans

RECRUITING

Hôpital Bichat - Claude - Bernard, Paris

NOT_YET_RECRUITING

Reims - CHU, Reims

NOT_YET_RECRUITING

Rouen - CHU, Rouen

NOT_YET_RECRUITING

Hôpital privé de la Loire, Saint-Etienne

NOT_YET_RECRUITING

Saint-Nazaire - Clinique Mutualiste de l'Estuaire, Saint-Nazaire

NOT_YET_RECRUITING

Centre Hospitalier Intercommunal, Toulon

NOT_YET_RECRUITING

CHRU de Tours, Tours

02100

NOT_YET_RECRUITING

Centre Hospitalier, Saint-Quentin

All Listed Sponsors
lead

Intergroupe Francophone de Cancerologie Thoracique

OTHER