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MEK Inhibitor

CDK4/6 + MEK Inhibitors for Lung Cancer

Phase 1

Waitlist Available

Led By Geoffrey Shapiro, MD, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan

Participants must have normal organ and marrow function as defined below

Must not have

History of retinal degenerative disease

Presence of neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration on screening ophthalmologic exam

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a possible treatment for lung cancer that involves two drugs.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer that has a KRAS gene mutation. They must have measurable disease, be in good physical condition (ECOG < 2), and have normal organ/marrow function. Prior treatments are allowed if recovered from their effects. Participants need to agree to use contraception, undergo tumor biopsies, take oral meds, and have adequate heart function.

What is being tested?

The study tests the combination of two drugs: Palbociclib and Binimetinib as a treatment for lung cancer with KRAS mutations. It aims to see how well these drugs work together against this specific type of cancer.

What are the potential side effects?

Possible side effects include fatigue, nausea, diarrhea, blood count changes affecting immunity or clotting risk, liver enzyme alterations suggesting liver stress or damage; heart rhythm abnormalities could also occur.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor that can be measured with a scan.

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My organ and bone marrow functions are normal.

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I am 18 years old or older.

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I am willing to have tumor biopsies before and during treatment.

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My advanced lung cancer has a KRAS mutation and cannot be cured with surgery or radiation.

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I can do most of my daily activities without help.

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I can take pills by mouth.

Exclusion Criteria

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

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I have a history of eye diseases that cause vision loss.

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I have been diagnosed with a specific eye condition after an eye exam.

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I am not currently taking any proton-pump inhibitors.

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I don't have ongoing issues with absorbing medication due to stomach or bowel problems.

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I am HIV-positive and not on antiretroviral therapy.

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I have an active hepatitis B or C infection.

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I am not on anticoagulants that can't be paused for tumor biopsies.

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I am not taking strong medications that affect drug metabolism.

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I have a history of heart rhythm problems.

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I need ongoing steroids for my brain metastases symptoms.

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I have a muscle disorder that causes high CK levels.

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I have been diagnosed with Gilbert's syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose

Safety and tolerability of Palbocilib and Binimetinib

progression free survival

Secondary study objectives

Objective Response

Pharmacokinetic parameters of palbociclib and binimetinib

Target engagement of palbociclib and binimetinib

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507

63%

Neutrophil count decreased

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Diarrhea

17%

Headache

17%

Mucositis

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Flu like symptoms

10%

Obesity

Pain in extremity

Constipation

Fever

Pruritus

Bone pain

Dizziness

Dyspepsia

Hot flashes

Dysgeusia

Pain

Nail disorder

Respiratory infection

Abdominal pain

Spinal cord compression

Heart failure

Bronchial infection

Pleural effusion

Ascites

Urinary tract infection

Breast infection

Dyspnea

Gallbladder infection

Renal failure

Thromboembolic event

Dislocation of hip

Palmar-plantar erythrodysesthesia syndrome

Osteonecrosis of jaw

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Palbociclib Plus Fulvestrant

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

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: Binimetinib Combine with Palbociclib Phase 1Experimental Treatment2 Interventions

* Palbociclib will be administered orally once daily * Patients will be dosed with palbociclib for three weeks out of every four weeks per cycle * Binimetinib will be administered orally twice daily * Patients will be dosed with Binimetinib continuously through the four weeks per cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Binimetinib

2018

Completed Phase 3

~1250

Palbociclib

2017

Completed Phase 3

~3880