Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 7, 2024

Primary Completion Date

September 30, 2024

Study Completion Date

September 30, 2024

Conditions
NSCLC, Stage IIIALK-rearrangement
Interventions
DRUG

Brigatinib

"Brigatinib is administered for 3 years or until progression of disease, or unacceptable toxicities or withdrawal of consent, whatever occurs first. After the treatment period of 3 years, patient's ongoing treatment will be managed according to local standard and best clinical practice.~Brigatinib should be taken approximately at the same time each day. It may be taken with or without food. Patients shall be instructed to swallow the tablets whole and not crush or chew them."

DRUG

Durvalumab

Patients in the control arm will be observational, or, as per investigators choice, patients may receive durvalumab, administered within the label in the respective country.

Trial Locations (20)

Unknown

CHU Angers, Angers

Caen - CHU, Caen

Hôpital de Marseille, Marseille

IRCCS Instituto Tumori Giovanni Paolo II, Bari

IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola

AOU Maggiore della Carità, Novara

Fondazione IRCCS Policlinico S. Matteo, Pavia

Santa Maria della Misericordia Hospital, Perugia

AULSS2 Marca Trevigiana Treviso, Treviso

Universita di Verona - Department of Medicine, Verona

Medical University Gdansk, Gdansk

Hospital Universitario Dr Balmis Alicante - ISABIAL, Alicante

Hospital de la Santa Creu i Sant Pau, Barcelona

Hospital Vall d'Hebron, Barcelona

Hospital Universitario Basurto, Bilbao

Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera

Hospital Universitario Lucus Augusti, Lugo

H. Puerta de Hierro Majadahonda, Majadahonda

Royal Marsden Hospital (Fulham Road), London

Royal Marsden Hospital (Sutton), London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

ETOP IBCSG Partners Foundation

NETWORK