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

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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