98 Participants Needed

Encorafenib + Binimetinib for Non-Small Cell Lung Cancer

Recruiting at 199 trial locations
PP
Overseen ByPfizer Pfizer CT.gov Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in combination with binimetinib in patients with BRAFV600E-mutant metastatic non-small cell lung cancer (NSCLC). Patients who are either treatment-naïve, OR who have received 1) first-line treatment with standard platinum-based chemotherapy, OR 2) first-line treatment with an anti-programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) inhibitor given alone or in combination with platinum-based chemotherapy will be enrolled.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have previously been treated with BRAF or MEK inhibitors, you would not be eligible for this trial.

Is the combination of Encorafenib and Binimetinib safe for humans?

The combination of Encorafenib and Binimetinib has shown an acceptable safety profile in patients with certain types of cancer, such as melanoma and non-small-cell lung cancer. Some side effects have been reported, including visual symptoms and lower incidence of fever and sensitivity to sunlight compared to other similar treatments.12345

How is the drug combination of Encorafenib and Binimetinib unique for treating non-small cell lung cancer?

The combination of Encorafenib and Binimetinib is unique because it targets specific genetic mutations (BRAFV600E) in non-small cell lung cancer, using a BRAF inhibitor and a MEK inhibitor to block cancer cell growth, which is a novel approach compared to traditional chemotherapy.12346

What data supports the effectiveness of the drug combination of Encorafenib and Binimetinib for treating non-small cell lung cancer?

The combination of Encorafenib and Binimetinib has shown effectiveness in treating melanoma with specific mutations, and early studies suggest it may also be effective for non-small cell lung cancer with similar mutations.13478

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with advanced Stage IV non-small cell lung cancer (NSCLC) that has a specific mutation called BRAFV600E. It's open to those who haven't had treatment or have only had one prior line of platinum-based chemo or anti-PD-1/PD-L1 therapy. Participants need to be relatively healthy, able to perform daily activities with ease (ECOG 0-1), and have normal organ function.

Inclusion Criteria

You have a tumor that can be measured using specific guidelines for evaluating cancer.
My blood tests show normal white blood cells, platelets, and hemoglobin levels.
Your total bilirubin levels in the blood are not more than 1.5 times the upper limit of normal.
See 10 more

Exclusion Criteria

I have not taken BRAF or MEK inhibitors before.
I have not had a stroke or blood clot in the last 3 months.
I have brain metastasis or other active brain-related cancer issues.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive encorafenib and binimetinib orally in 28-day cycles

Up to 36 months
Cycle 1 Day 1, Cycle 2 Day 1 ±3 Days, Day 1 ±3 Days in Subsequent Cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days
Safety follow-up visit (30 days [±7 days] after the EOT visit)

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Binimetinib
  • Encorafenib
Trial Overview The study tests the combination of two drugs, encorafenib and binimetinib, in patients with a certain type of lung cancer mutation. It aims to see how safe this combo is and how well it works either as an initial treatment or after first-line therapy.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment PeriodExperimental Treatment2 Interventions

Binimetinib is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Mektovi for:
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Approved in European Union as Mektovi for:
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Approved in Canada as Mektovi for:
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Approved in Japan as Mektovi for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

In a phase II study involving 98 patients with BRAFV600E-mutant metastatic non-small-cell lung cancer (NSCLC), the combination of encorafenib and binimetinib achieved a confirmed objective response rate of 75% in treatment-naïve patients and 46% in previously treated patients, indicating significant efficacy.
The treatment was generally well-tolerated, with common side effects including nausea (50%) and diarrhea (43%), but it also led to dose reductions in 24% of patients and one serious adverse event of intracranial hemorrhage, highlighting the importance of monitoring safety.
Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non-Small-Cell Lung Cancer.Riely, GJ., Smit, EF., Ahn, MJ., et al.[2023]
Encorafenib and binimetinib, a combination of a BRAF inhibitor and a MEK inhibitor, received FDA approval in June 2018 for treating patients with unresectable or metastatic melanoma that has specific BRAF mutations (V600E or V600K).
The combination therapy is also being explored in ongoing phase III clinical trials for metastatic colorectal cancer, indicating its potential broader application beyond melanoma.
Encorafenib and Binimetinib: First Global Approvals.Shirley, M.[2019]
The combination of encorafenib and binimetinib was found to be safe and showed promising activity in patients with BRAF V600E-mutant solid tumors, with a recommended phase 2 dose established for further studies.
In phase II, the treatment resulted in confirmed responses in 67% of BRAFi-naïve melanoma patients, indicating significant efficacy, while the most common serious side effect was increased alanine aminotransferase levels.
A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with BRAFV600E/K -mutant Solid Tumors.Sullivan, RJ., Weber, J., Patel, S., et al.[2021]

Citations

Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non-Small-Cell Lung Cancer. [2023]
Encorafenib and Binimetinib: First Global Approvals. [2019]
A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with BRAFV600E/K -mutant Solid Tumors. [2021]
The discovery and development of binimetinib for the treatment of melanoma. [2021]
Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: Results from a multicentre, open-label, randomised, phase III study (COLUMBUS). [2021]
[Long-term efficacy of encorafenib plus binimetinib combined treatment: case report.] [2021]
Visual symptoms in a patient treated with MEK inhibitors. [2022]
The spectrum of cutaneous adverse events during encorafenib and binimetinib treatment in B-rapidly accelerated fibrosarcoma-mutated advanced melanoma. [2019]
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