Encorafenib + Binimetinib for Non-Small Cell Lung Cancer

Recruiting at199 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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.

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.

Treatment Details

Interventions

• Binimetinib (Kinase Inhibitor)
• Encorafenib (Kinase Inhibitor)

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.

Participant Groups

Group I: Treatment Period Experimental Treatment 2 Interventions

Study treatment with encorafenib and binimetinib will be self-administered orally without regard to food. Patients will receive the following per 28-day (± 3 days) cycle: * Encorafenib: 450 mg (6 × 75 mg capsule) once daily (QD) * Binimetinib: 45 mg (3 × 15 mg tablet) twice daily (BID)

Binimetinib is already approved in Canada, Japan for the following indications:

Approved in Canada as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

Approved in Japan as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

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

Pfizer

Chief Medical Officer

MD from McGill University