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Kinase Inhibitor

Encorafenib + Binimetinib for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate bone marrow function characterized by ANC ≥ 1.5 × 10⁹/L, Platelets ≥ 100 × 10⁹/L, Hemoglobin ≥ 8.5 g/dL

Presence of a BRAFV600E mutation in lung cancer tissue as determined by a local laboratory assay or the presence of other BRAFV600 mutations other than V600E (i.e. K or D)

Must not have

Previous treatment with any BRAF inhibitor or any MEK inhibitor prior to screening and enrollment

Patients with symptomatic brain metastasis, leptomeningeal disease or other active central nervous system (CNS) metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the time from the date of first dose of study intervention to the date of death due to any cause (up to 36 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for patients with a specific type of lung cancer. The trial will test how well the new therapy works and if it is safe.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include fatigue, skin rash, vision changes, abnormal liver blood tests, high blood pressure, muscle pain and heart problems. Since everyone reacts differently to medication, not all participants may experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood tests show normal white blood cells, platelets, and hemoglobin levels.

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My lung cancer has a specific BRAF mutation.

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My lung cancer is confirmed as non-small cell type and is in Stage IV.

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I have not had systemic therapy for my advanced cancer, or I've only had specific first-line treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My lung cancer has a specific BRAF mutation.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My lung cancer is confirmed as non-small cell type and is in Stage IV.

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My liver and kidney functions are within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken BRAF or MEK inhibitors before.

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I have brain metastasis or other active brain-related cancer issues.

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I have heart problems or significant heart disease.

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I have a muscle disorder that might increase my CK levels.

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My cancer has a specific genetic change (EGFR, ALK, or ROS1).

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I have or am at risk for blocked veins in my eye.

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I have had more than one treatment for cancer that has spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the time from the date of first dose of study intervention to the date of death due to any cause (up to 36 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the time from the date of first dose of study intervention to the date of death due to any cause (up to 36 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and the time from the date of first dose of study intervention to the date of death due to any cause (up to 36 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With Confirmed Objective Response (OR) as Determined by Independent Radiology Review (IRR)

Secondary study objectives

Disease Control Rate (DCR) by IRR and Investigator Assessments

Duration of Response (DoR) by IRR and Investigator Assessments

Kaplan-Meier Estimates of Overall Survival (OS)

+9 more

Side effects data

From 2023 Phase 2 trial • 95 Patients • NCT03693170

67%

Diarrhoea

44%

Nausea

40%

Rash

40%

Dermatitis acneiform

36%

Vomiting

33%

Abdominal pain

32%

Asthenia

32%

Dry skin

26%

Constipation

24%

Anaemia

23%

Decreased appetite

19%

Fatigue

16%

Dyspnoea

14%

Vision blurred

13%

Dysgeusia

13%

Pyrexia

13%

Lipase increased

13%

Pruritus

12%

Skin fissures

12%

Paronychia

11%

Amylase increased

11%

Headache

Back pain

Blood creatinine increased

Dyspepsia

Stomatitis

Arthralgia

Cough

Abdominal pain upper

Hypoalbuminaemia

Weight decreased

Rectal haemorrhage

Large intestinal obstruction

Abdominal discomfort

Dysphonia

Myalgia

Hypertrichosis

Hypomagnesaemia

Mucosal inflammation

Acute kidney injury

Intestinal obstruction

Insomnia

Muscle spasms

Palmar-plantar erythrodysaesthesia syndrome

Blood creatine phosphokinase increased

Erythema

Flatulence

Hyperkalaemia

Small intestinal obstruction

Renal failure

Myocardial infarction

Cardiac failure

Lower gastrointestinal haemorrhage

Escherichia sepsis

Myocarditis

Biliary tract infection

Cellulitis

Lymph node tuberculosis

Respiratory tract infection

Respiratory failure

Diverticulum

Enteritis

Enterocolitis

Intra-abdominal fluid collection

Large intestine perforation

Sepsis

Urinary tract infection

Diversion colitis

Femoral neck fracture

Infusion related reaction

Lumbar vertebral fracture

Pancreatitis acute

Subileus

General physical health deterioration

Bile duct stenosis

Cholangitis

Cholecystitis

Hepatic function abnormal

Appendicitis

Bacteraemia

Streptococcal bacteraemia

Tuberculosis

Detachment of retinal pigment epithelium

Alanine aminotransferase increased

Aspartate aminotransferase increased

Blood bilirubin increased

Gamma-glutamyltransferase increased

Hypokalaemia

Tumour associated fever

Dizziness

Haematuria

Nephritis

Nephrolithiasis

Pleural effusion

Pneumonia aspiration

Pneumonitis

100%

80%

60%

40%

20%

Study treatment Arm

1 Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment PeriodExperimental Treatment2 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

encorafenib

2019

Completed Phase 2

~160

binimetinib

2018

Completed Phase 2

~140