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Brief Title: Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)
Official Title: A Phase II Randomized, Open-Labelled, Multicenter Study of Safety & Efficacy of Combination Brigatinib and Carboplatin-Pemetrexed Therapy or Brigatinib Monotherapy as First-Line Treatment in Advanced ALK-Positive Non-Small Cell Lung Cancer
Study ID: NCT05200481
Brief Summary: This is a phase II randomized, open-labelled, non-comparative multicenter study in which ALK+ NSCLC patients who are naïve of treatment for advanced disease will be randomized to receive brigatinib monotherapy (Arm A) or brigatinib and carboplatin-pemetrexed therapy (Arm B). An estimated 110 patients (55 in Arm A, 55 in Arm B) will be enrolled at approximately 30 centers. A safety phase will evaluate the safety of brigatinib with carboplatin and pemetrexed treatment combination (Arm B). The first twenty-six patients enrolled in Arm B will represent the population of the safety phase. Patients will be treated until they experience progressive disease, intolerable toxicity, or another discontinuation criterion is met. Continuation of brigatinib beyond progression is permitted, at the investigator's discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 12 months ≤ 69% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 86% or more of patients in Arm B would achieve progression free survival at 12 months.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHU d'Angers, Angers, , France
CHU Besançon - Hôpital J. MINJOZ, Besançon, , France
Hôpital APHP Ambroise Paré, Boulogne, , France
Hospices Civils de Lyon - Hôpital Louis Pradel, Bron, , France
CHU Côte de Nacre, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Hospitalier Intercommunal de Créteil, Créteil, , France
Centre Georges-François Leclerc, Dijon, , France
Chu Grenoble, Grenoble, , France
Hôpital Calmette, Lille, , France
CHU Dupuytren, Limoges, , France
Centre Léon Bérard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
Hôpital Nord, Marseille, , France
Hôpital Arnaud de Villeneuve, Montpellier, , France
Centre Hospitalier, Mulhouse, , France
Hôpital Cochin, Paris, , France
Institut CURIE, Paris, , France
Hôpital BICHAT, Paris, , France
Hôpital TENON, Paris, , France
Hôpital Haut-Lévèque, Pessac, , France
CHU Rennes - Hôpital Pontchaillou, Rennes, , France
Hôpital Charles Nicolle, Rouen, , France
Centre René Huguenin, Saint-Cloud, , France
Institut de Cancérologie de l'Ouest - René Gauducheau, Saint-Herblain, , France
Centre Hospitalier, Saint-Quentin, , France
Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg, Strasbourg, , France
Hôpital Foch, Suresnes, , France
HIA Sainte-Anne, Toulon, , France
Hôpital Larrey (CHU), Toulouse, , France
Centre Alexis Vautrin, Vandœuvre-lès-Nancy, , France
Centre Hospitalier de Villefranche-sur-Saône, Villefranche-sur-Saône, , France
Name: Michael DURUISSEAUX, Dr
Affiliation: Hospices Civils de Lyon - Hôpital Louis Pradel
Role: PRINCIPAL_INVESTIGATOR
Name: Aurélie SWALDUZ, Dr
Affiliation: Centre Leon Berard
Role: PRINCIPAL_INVESTIGATOR