Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Encorafenib: 450 mg (6 × 75 mg capsule) QD Binimetinib: 45 mg (3 × 15 mg tablet) BID

Encorafenib 75 MG

Binimetinib 15 MG

Elodie Amour

Philippe ROMAND, Dr

José Hureaux, Dr

Alma STANCU, MD

Sophie COUSIN, Dr

Etienne GIROUX-LEPRIEUR, MD

Margaux GEIER, Dr

Jeannick MADELAINE, Dr

Lionel MOREAU

Jean-Bernard AULIAC, Dr

Aurélie LAGRANGE

Denis MORO-SIBILOT

Cyril GUIBERT, Dr

Camille GUGUEN, Dr

Alexis CORTOT, Pr

Thomas Egenod, Dr

Maurice Pérol, Dr

Anne Madroszyk, Dr

Pascale TOMASINI

Benoit ROCH, Dr

Didier DEBIEUVRE, Dr

Christelle CLEMENT-DUCHENE, Dr

Josiane OTTO, Dr

Marie Wislez, Pr

Vincent Fallet, Dr

Gérard ZALCMAN, Pr

Clémence BASSE, Dr

Aldo RENAULT, Dr

Sébastien COURAUD, Dr

Charles Ricordel, Dr

Florian GUISIER

Charles Dayen, Dr

Céline Mascaux, Pr

Julien Mazieres, Pr

Delphine CARMIER, Dr

Luc ODIER, Dr

David Planchard, Dr

David Planchard

Charles Ricordel

A Phase II study of the BRAF inhibitor Encorafenib in combination with the MEK inhibitor Binimetinib in Patients with BRAFV600E-mutant metastatic Non-small Cell Lung Cancer

This is an open-label, multicenter, multi-cohort Phase 2 study of the combination of encorafenib and binimetinib in patients with previously treated and untreated BRAFV600E-mutant NSCLC.

ENCOrafenib With Binimetinib in bRAF NSCLC

A Phase II Study of the BRAF Inhibitor Encorafenib in Combination With the MEK Inhibitor Binimetinib in Patients With BRAFV600E-mutant Metastatic Non-small Cell Lung Cancer

Objective Response Rate at 6 months using RECIST1.1 criteria

Time from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause.

Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)

Time from enrollment until death due to any cause

Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

Intergroupe Francophone de Cancerologie Thoracique

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Glioma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Pancreatic Cancer

Neuroepithelioma

Binimetinib 45mg is orally administered twice daily.

Chigusa Morizane, M.D., Ph.D.

Tomoyuki Satake, M.D., Ph.D.

Tomoyuki Satake, M.D.

Ichiro Kinoshita, M.D., Ph.D.

Masafumi Kanai, M.D., Ph.D.

Keigo Komine, M.D., Ph.D.

Kenji Tsuchihashi, M.D., Ph.D.

This study is an open-label, parallel, 2-cohort, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of binimetinib in patients with advanced or recurrent low-grade glioma or pancreatic cancer harboring BRAF fusion/rearrangement.

This study is an open-label, parallel, 2-cohort, multicenter, investigator-initiated Phase 2 trial. Eligible patients are with recurrent low-grade glioma (grade 1 and grade 2 tumors according to WHO classification) or advanced or recurrent pancreatic cancer harboring BRAF fusion/rearrangement. Patients receive binimetinib 45mg administered orally, twice daily.

Analyses will be performed on each of the two cohorts:

Cohort A: low-grade glioma Cohort B: pancreatic cancer

Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)

Phase II Investigator-initiated Trial of Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)

Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, cohort B FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on RECIST v1.1. ORR will be confirmed by independent blinded central review assessment.

Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, cohort B FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on RECIST v1.1. ORR will be performed by investigator assessment.

Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on Response Assessment in Neuro-Oncology (RANO) criteria. ORR will be confirmed by local site investigator assessment.

Overall response rate (ORR) defined as the combined incidence of complete response (CR) PR and SD, within cohort A FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on Response Assessment in Neuro-Oncology (RANO) criteria. ORR will be confirmed by local site investigator assessment.

Progression-free survival (PFS) defined as the time from the date of enrollment to the date of the first documentation of objective progression of disease (PD), clinically diagnosed symptomatic deterioration, or death due to any cause in the absence of documented PD, whichever occurs first within cohort A FAS and cohort B FAS.

Overall survival (OS) defined as the time from date of enrollment to date of death due to any cause within cohort A FAS and cohort B FAS.

Disease control rate (DCR) defined as the percentage of patients with a confirmed complete response (CR), partial response (PR) or stable disease (SD) as the best overall according to RECIST version 1.1 within cohort A FAS and cohort B FAS.

Duration of Response (DOR) defined as the time from the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first within cohort A FAS and cohort B FAS.

Defined as the percentage of patients who experienced each adverse event. The severity of AEs were evaluated by the investigator according to Japan Clinical Oncology Group (JCOG) Japanese translation of the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0-JCOG) within cohort A FAS and cohort B FAS.

Ono Pharmaceutical Co. Ltd

National Cancer Center, Japan

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ENCOrafenib With Binimetinib in bRAF NSCLC	NCT04526782	Non Small Cell ... BRAF V600E	Encorafenib 75 ... Binimetinib 15 ...	18 Years -	Intergroupe Francophone de Cancerologie Thoracique
Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)	NCT06159478	Low-grade Gliom... Pancreatic Canc...	Binimetinib 15 ...	12 Years -	National Cancer Center, Japan

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