ENCOrafenib With Binimetinib in bRAF NSCLC
ENCO-BRAF
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
1 other identifier
interventional
119
1 country
36
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2021
Longer than P75 for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 26, 2020
CompletedStudy Start
First participant enrolled
January 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedNovember 18, 2025
November 1, 2025
4.5 years
August 21, 2020
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate
Objective Response Rate at 6 months using RECIST1.1 criteria
6 months
Secondary Outcomes (4)
Duration Response Rate
about 12 months
Progression-free Survival
about 24 months
Overall Survival
about 24 months
Incidence, type and severity of adverse events
From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)
Study Arms (2)
Cohort 1 (1st line)
EXPERIMENTALEncorafenib: 450 mg (6 × 75 mg capsule) QD Binimetinib: 45 mg (3 × 15 mg tablet) BID
Cohort 2 (2nd line)
EXPERIMENTALEncorafenib: 450 mg (6 × 75 mg capsule) QD Binimetinib: 45 mg (3 × 15 mg tablet) BID
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- Male or female aged at least 18 years old.
- Histologically confirmed diagnosis of NSCLC that is currently Stage IV (M1a, M1b or M1c AJCC 8th edition).
- ECOG performance status of 0-1.
- Able to swallow and retain oral medication.
- Presence of a BRAFV600E mutation in lung cancer tissue as determined by a local laboratory assay.
- The Investigator must confirm prior to enrolment that the patient has adequate tumor tissue available to determine BRAFV600E mutation status by central laboratory for confirmation.
- Note: Tumor tissue collected after the patient was diagnosed with metastatic disease is preferred.
- Tumor tissue sample must not be from locations previously radiated. Tumor sample must be 1 block or 10 to 15 unstained slides of analyzable tissue and one H\&E slide.
- Patients i) (COHORT A) who are either treatment-naïve (e.g., no prior systemic therapy for advanced/metastatic disease), ii) (COHORT B) who are in progression after having received 1) first-line platinum-based chemotherapy OR 2) first-line treatment with an anti-PD-1/L-1 inhibitor given alone or in combination with platinum-based chemotherapy or in combination with immunotherapy (e.g, ipilimumab) with or without platinum-based chemotherapy.
- Note: Alternative chemotherapy regimens are acceptable if the patient was platinum intolerant or ineligible.
- Patients with early stage disease (e.g., Stages I-III) who have had surgery followed by chemotherapy (e.g., treatment in the adjuvant setting), and present with new lesions or evidence of disease recurrence (e.g., metastatic disease), within 12 months of completing chemotherapy, would be considered as had received a first-line therapy.
- Maintenance therapy given after first-line therapy in the metastatic setting will not be considered a separate regimen, provided there was no documentation of disease progression between completion of first-line therapy and the start of maintenance therapy.
- Presence of measurable disease based on RECIST v1.1.
- +8 more criteria
You may not qualify if:
- Patients with nonsquamous carcinoma who have documentation of any of the following: EGFR mutation, ALK fusion oncogene or ROS1 rearrangement.
- Previous treatment with any other BRAF inhibitor (e.g., dabrafenib, vemurafenib…), or any other MEK inhibitor (e.g., trametinib, cobimetinib…) prior to screening and enrolment.
- \. Patients who have received more than 1 prior line of systemic therapy in the advanced/metastatic setting for Cohort B.
- Note: Generally, treatments that are separated by an event of progression are considered to represent another line of therapy.
- Any therapeutic intervention including systemic therapy, surgery concurrent with or followed by systemic therapy, radiation concurrent with systemic therapy, or stereotactic radiation/radiosurgery, initiated or added to an existing therapy for oligometastatic disease will be considered a new line of therapy.
- Palliative radiation to solitary lesions is permitted and will not be considered a new line of therapy.
- Surgery/radiosurgery for CNS metastases is permitted and will not be considered a line of therapy as long as the surgery/radiosurgery was not given with systemic therapy (neoadjuvant or adjuvant).
- Surgery followed by chemotherapy in the metastatic setting will be considered a line of therapy.
- \. Receipt of anticancer therapies or investigational drugs within the following intervals before the first administration of study treatment: i) ≤14 days for chemotherapy, targeted small molecule therapy, radiation therapy, immunotherapy, or antineoplastic biologic therapy (e.g., erlotinib, crizotinib, bevacizumab etc.).
- ii) ≤14 days or 5 half-lives (minimum of 14 days) for investigational agents or devices. For investigational agents with long half-lives (e.g., \> 5 days), enrolment before the fifth half-life requires sponsor approval.
- iii) Palliative radiation therapy must be complete 7 days prior to the first dose of study treatment.
- \. Patients who have had major surgery (e.g., inpatient procedure with regional or general anesthesia) ≤ 6 weeks prior to start of study treatment.
- \. For cohort B : Patient has not recovered to ≤Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
- Note: Stable chronic conditions (≤ Grade 2) that are not expected to resolve (e.g., neuropathy, myalgia, alopecia, and prior therapy-related endocrinopathies) are exceptions.
- \. Current use of a prohibited medication (including herbal medications, supplements, or foods), or use of a prohibited medication ≤1 week prior to the start of study treatment.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Annemasse - CH
Ambilly, 74100, France
Angers - CHU
Angers, France
Avignon - Institut Sainte-Catherine
Avignon, 84918, France
Bordeaux - Institut Bergonié
Bordeaux, France
Boulogne - Ambroise Paré
Boulogne-Billancourt, France
Brest - CHU
Brest, France
Caen - CHU Côte de Nacre
Caen, 14000, France
CH
Colmar, France
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000, France
Centre Georges François Leclerc
Dijon, France
CHRU Grenoble
Grenoble, France
La Roche Sur Yon - CH
La Roche-sur-Yon, 85925, France
CH Le Mans
Le Mans, France
CHRU de Lille
Lille, France
CHU Dupuytren
Limoges, 87042, France
Centre Léon Bérard
Lyon, 69000, France
Institut Paoli Calmettes
Marseille, 13273, France
AP-HM Hôpital Nord
Marseille, France
Montpellier - CHRU
Montpellier, 34295, France
Mulhouse - GHRMSA
Mulhouse, France
Nancy - Institut de Cancérologie de Lorraine
Nancy, France
Centre Antoine LACASSAGNE
Nice, France
AP-HP Hôpital Cochin
Paris, 75014, France
AP-HP Hôpital Tenon
Paris, 75970, France
Hôpital BICHAT
Paris, France
Paris - Institut Curie
Paris, France
Centre Hospitalier Général - Pau
Pau, 64000, France
Lyon - URCOT
Pierre-Bénite, France
CHU Rennes - Hôpital Pontchaillou
Rennes, 35033, France
CHU Charles Nicolle
Rouen, France
Saint Quentin - CH
Saint-Quentin, 02100, France
Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
CHU Toulouse - Pneumologie
Toulouse, France
Tours - CHU
Tours, 37000, France
Villefranche-Sur-Saône - Hôpital Nord-Ouest
Villefranche-sur-Saône, France
Gustave Roussy
Villejuif, 94805, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Planchard
Gustave Roussy (Villejuif - France)
- PRINCIPAL INVESTIGATOR
Charles Ricordel
CHU Rennes,France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
August 26, 2020
Study Start
January 19, 2021
Primary Completion
July 16, 2025
Study Completion
March 1, 2026
Last Updated
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
The individual participant data underlying the results reported in this article, as well as the study protocol and statistical analysis plan, will be made available after deidentification immediately following publication and for three years. Researchers who provide a methodologically sound proposal for any purpose may direct proposals to contact@ifct.fr. To gain access, data requestors will need to sign a data access agreement that requires approval by the French Cooperative Thoracic Intergroup.