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Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

A Multicentre, Randomised, Phase II Trial of Brigatinib Consolidation Versus Observation or Durvalumab in Patients with Unresectable Stage III NSCLC and ALK-rearrangement, After Definitive Chemo-radiotherapy

NCT05718297•ETOP IBCSG Partners Foundation

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pathologically documented, treatment naïve unresectable stage III NSCLC
•Documented ALK-fusion, tested locally on tumour tissue by a validated method (DNA NGS, RNA NGS, FISH, IHC, or ctDNA)
•ECOG Performance Status 0-1
•Age ≥18 years
•Patient is a candidate to receive chemo-radiotherapy, as per investigator's assessment (including adequate haematological, renal and liver function as per local guidelines).
•Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 5 weeks before enrolment.
•Ability to comply with the trial protocol, in the investigator's judgment.
•Written IC for trial participation must be signed and dated by the patient and the investigator prior to any trial-related intervention, including the submission of mandatory biomaterial.
•Eligibility criteria for randomisation Randomisation of eligible patients must occur within 8 weeks after the last radiotherapy fraction.
•Completion of thoracic radiotherapy
+11 more criteria

Exclusion Criteria

•Diagnosis of another primary malignancy other than NSCLC. With the exception of adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years since the diagnosis of the other primary malignancy.
•Prior treatment for NSCLC
•Any evidence of stage IV NSCLC
•Significant, uncontrolled, or active cardiovascular disease
•Uncontrolled hypertension Patients with hypertension should be under treatment on study entry to control blood pressure.
•History or the presence at baseline of pulmonary interstitial disease, drug-related pneumonitis.
•Ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.
•Malabsorption syndrome or other GI illness that could affect oral absorption of brigatinib.
•Known or suspected hypersensitivity to brigatinib or its excipients.
•Any concurrent medical condition which, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of brigatinib.
+3 more criteria

Locations (20)

CHU Angers

Angers, France

Caen - CHU

Caen, France

Hôpital de Marseille

Marseille, France

IRCCS Instituto Tumori Giovanni Paolo II

Bari, Italy

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

Meldola, Italy

AOU Maggiore della Carità

Novara, Italy

Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Santa Maria della Misericordia Hospital

Perugia, Italy

AULSS2 Marca Trevigiana Treviso

Treviso, Italy

Universita di Verona - Department of Medicine

Verona, Italy

Key Dates

Start Date

June 7, 2024

Primary Completion Date

September 30, 2024

Completion Date

September 30, 2024

Last Updated

October 8, 2024

Conditions

NSCLC, Stage IIIALK-rearrangement

Interventions

Brigatinib

DRUG

Durvalumab

DRUG

Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung Cancer

NCT06614231

NSCLC, Stage IIIANSCLC (non-small Cell Lung Cancer)

View study

UNKNOWNPHASE2

Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities

NCT05311709

Lung CancerNSCLC, Stage III+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung Cancer

Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities

Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations

SHR-1701 for Consolidation Therapy After Concurrent Chemoradiotherapy in Inoperable Stage III NSCLC