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Kinase Inhibitor

Encorafenib + Binimetinib for Non-Small Cell Lung Cancer

Q: In what therapeutic contexts is encorafenib usually administered?

Patients suffering from metastatic <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, unresectable melanoma, or having a BRAF V600K mutation can benefit from encorafenib treatment.

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)

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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%

Pyrexia

13%

Dysgeusia

13%

Lipase increased

13%

Pruritus

12%

Skin fissures

12%

Paronychia

11%

Amylase increased

11%

Headache

Back pain

Blood creatinine increased

Stomatitis

Arthralgia

Cough

Dyspepsia

Abdominal pain upper

Hypoalbuminaemia

Rectal haemorrhage

Weight decreased

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

Lower gastrointestinal haemorrhage

Respiratory tract infection

Biliary tract infection

Escherichia sepsis

Cellulitis

Lymph node tuberculosis

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

Cardiac failure

Myocardial infarction

Myocarditis

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

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

~100

binimetinib

2017

Completed Phase 2

~80

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,575 Previous Clinical Trials

10,923,003 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,482 Previous Clinical Trials

8,099,265 Total Patients Enrolled

Media Library

Binimetinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03915951 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Treatment Period

Non-Small Cell Lung Cancer Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT03915951 — Phase 2

Binimetinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03915951 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what therapeutic contexts is encorafenib usually administered?

"Patients suffering from metastatic melanoma, unresectable melanoma, or having a BRAF V600K mutation can benefit from encorafenib treatment."

Answered by AI

Are there any opportunities to enroll in this research program at the moment?

"According to clinicaltrials.gov, this clinical trial is no longer recruiting subjects. It was initially posted on June 4th 2019 and last updated November 16 2022; however there are an additional 2012 trials actively looking for patients at the present moment."

Answered by AI

How many individuals have been recruited to take part in this research project?

"Unfortunately, this clinical trial has concluded its recruitment period. The study was first posted on June 4th, 2019 and was last updated November 16th, 2022. Fortunately, 1949 trials targeting non-small cell lung cancer are presently enlisting patients and 63 studies with encorafenib require participants to join as well."

Answered by AI

How many locations are overseeing the management of this clinical trial?

"This trial has recruited 100 patients from across the country, including Barnes-Jewish Hospital in Saint Louis, Ohio State Outpatient Care Lewis Center in Lewis Center and The Ohio State University James Cancer Hospital in Columbus."

Answered by AI

Are there any precedents to the current research involving encorafenib?

"Since its inception in 2011 at LMU Klinikum der Universität, 29 clinical trials have been completed using encorafenib. Presently, 63 active studies are occurring throughout the world; Saint Louis, Missouri alone is hosting several of these investigations."

Answered by AI

Is this new research pioneering a fresh approach?

"Since its inception in 2011, sponsored by Pfizer Inc., encorafenib has been rigorously tested. After the initial trial involving 183 patients yielded positive results, it was approved for use during Phase 2 trials. In total, there are currently 63 active studies utilizing this medication across 1256 cities and 41 countries worldwide."

Answered by AI