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

Sponsor
ETOP IBCSG Partners Foundation
Study ID
NCT05718297
Phase
PHASE2
Status
Withdrawn

Conditions

  • ALK-rearrangement
  • NSCLC, Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brigatinib — DRUG
    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.
  • Durvalumab — DRUG
    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.

Study Details

BOUNCE is an international multicentre randomised phase II trial. The trial treatment consists of brigatinib 180 mg once daily p.o., with seven day lead-in at 90 mg once daily, for 3 years or until progression of disease. The primary objective of this trial is to evaluate the efficacy in terms of progression-free survival (PFS) for brigatinib consolidation, compared to observation/durvalumab, in patients with unresectable stage III NSCLC and ALK-rearrangement who completed definitive chemo-radiotherapy without disease progression.

Key Dates

Start date
Jun 7, 2024
Status verified
Oct 2024
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    Brigatinib 180 mg once daily p.o., with seven day lead-in at 90 mg once daily, for 3 years or until progression of disease, or unacceptable toxicities or withdrawal of consent
  • Active Comparator: Control arm
    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.

Primary Outcome Measure

Progression-free survival, according to RECIST v1.1, evaluated in the ITT cohort. PFS will be compared between the two arms. [ Time Frame: From the date of enrolment until last tumour assessment (approximately 45-48 months after enrolment of the first patient) ]

Related Studies