NCT05200481View on ClinicalTrials.gov

Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

May 18, 2022

Primary Completion Date

April 30, 2025

Study Completion Date

October 31, 2028

Conditions
Non Small Cell Lung CancerALK Gene Mutation
Interventions
DRUG

Brigatinib 180 MG

Patients will receive brigatinib orally at a dose of 90 mg QD for a 7 days lead-in period followed by 180 mg QD continuously, with or without food, in 28-day cycles until progression. Dose reductions are possible.

DRUG

Carboplatin

Patients will receive pemetrexed 500 mg/m² followed by carboplatin to target AUC of 5 mg/mL/min both on Day 1 as IV infusion every 3 weeks for 4 infusions. The first infusion of carboplatin and pemetrexed will be administrated at day 8 of brigatinib treatment, at time of dose escalation from 90 mg QD to 180mg QD continuously.

DRUG

Pemetrexed

Patients will receive pemetrexed 500 mg/m² followed by carboplatin to target AUC of 5 mg/mL/min both on Day 1 as IV infusion every 3 weeks for 4 infusions. The first infusion of carboplatin and pemetrexed will be administrated at day 8 of brigatinib treatment, at time of dose escalation from 90 mg QD to 180mg QD continuously.

Trial Locations (29)

13273

Institut Paoli Calmettes, Marseille

13915

Hôpital Nord, Marseille

14000

CHU Côte de Nacre, Caen

21079

Centre Georges-François Leclerc, Dijon

25030

CHU Besançon - Hôpital J. MINJOZ, Besançon

31059

Hôpital Larrey (CHU), Toulouse

33604

Hôpital Haut-Lévèque, Pessac

34295

Hôpital Arnaud de Villeneuve, Montpellier

35033

CHU Rennes - Hôpital Pontchaillou, Rennes

38043

Chu Grenoble, Grenoble

44805

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

49033

CHU d'Angers, Angers

54511

Centre Alexis Vautrin, Vandœuvre-lès-Nancy

59037

Hôpital Calmette, Lille

63011

Centre Jean Perrin, Clermont-Ferrand

67091

Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg, Strasbourg

68070

Centre Hospitalier, Mulhouse

69373

Centre Léon Bérard, Lyon

69655

Centre Hospitalier de Villefranche-sur-Saône, Villefranche-sur-Saône

69677

Hospices Civils de Lyon - Hôpital Louis Pradel, Bron

75014

Hôpital Cochin, Paris

75877

Hôpital BICHAT, Paris

75970

Hôpital TENON, Paris

76031

Hôpital Charles Nicolle, Rouen

83800

HIA Sainte-Anne, Toulon

87042

CHU Dupuytren, Limoges

92104

Hôpital APHP Ambroise Paré, Boulogne

94000

Centre Hospitalier Intercommunal de Créteil, Créteil

02100

Centre Hospitalier, Saint-Quentin

All Listed Sponsors
lead

Intergroupe Francophone de Cancerologie Thoracique

OTHER