Suspended

ENCO-BRAFEncorafenib and Binimetinib for BRAFV600E-mutant Metastatic Lung Cancer

Study Aim

This study aims to evaluate the effectiveness of Encorafenib and Binimetinib in treating adults with metastatic lung cancer carrying the BRAFV600E mutation by measuring the response rate at six months.

What is being tested

Encorafenib 75 MG

+ Binimetinib 15 MG

Drug

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years

+37 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: January 2021

See protocol details

Summary

Principal SponsorIntergroupe Francophone de Cancerologie Thoracique

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 19, 2021

Actual date on which the first participant was enrolled.

This clinical trial focuses on testing a combination of two drugs, Encorafenib and Binimetinib, to treat patients with a specific type of lung cancer called BRAFV600E-mutant metastatic non-small cell lung cancer. This type of cancer has a genetic mutation which makes it challenging to treat with standard therapies. The study aims to find out if this combination can effectively stop or slow down the growth of cancer in patients who have this mutation. Understanding if this treatment works could offer new hope and options for people with this difficult-to-treat cancer. In this study, participants receive the drugs Encorafenib and Binimetinib together. The treatment is given to see how well it works in shrinking tumors or stopping them from growing. The main way the study measures success is through the "objective response rate," which looks at how many patients experience tumor shrinkage or stability at six months, assessed using specific medical criteria known as RECIST1.1. This study is important to assess the potential benefits and understand any side effects of combining these drugs for this particular cancer type.

Official TitleA 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

NCT04526782

Principal SponsorIntergroupe Francophone de Cancerologie Thoracique

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

119 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

16 inclusion criteria required to participate

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.

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.

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21 exclusion criteria prevent from participating

Patient who aas has a known history of a positive test for HIV or known AIDS.

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.

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.

Patients with nonsquamous carcinoma who have documentation of any of the following: EGFR mutation, ALK fusion oncogene or ROS1 rearrangement.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 36 locations

Suspended

Annemasse - CH

Ambilly, FranceOpen Annemasse - CH in Google Maps

Suspended

Angers - CHU

Angers, France

Suspended

Avignon - Institut Sainte-Catherine

Avignon, France

Suspended

Brest - CHU

Brest, France

Suspended36 Study Centers