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MEK Inhibitor
Binimetinib + Pembrolizumab for Non-Small Cell Lung Cancer
Phase 1
Recruiting
Led By Natasha Leighl, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be able to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new combination therapy for lung cancer.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that hasn't spread to the brain, who haven't had recent heart issues or other cancers, and don't have immune system problems. They must not be on certain medications, have a life expectancy over 3 months, can take pills normally, and their organs must work well.Check my eligibility
What is being tested?
Researchers are testing if combining binimetinib (an experimental drug) with pembrolizumab is effective in treating advanced non-small cell lung cancer. The study will also determine the safest dose of binimetinib when used with pembrolizumab.See study design
What are the potential side effects?
Possible side effects include allergic reactions to either drug's ingredients, high blood pressure that doesn’t respond to treatment, inflammation of organs like lungs (pneumonitis), changes in heartbeat rhythm or vision problems due to retinal vein occlusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take pills and don't have major stomach or bowel issues affecting drug absorption.
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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 advanced, not small cell, and tests high for PDL-1 without certain gene changes.
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I can provide a sample of my tumor for genetic testing.
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My cancer can be measured by tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Incidence of adverse events
Recommended phase 2 dose
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 1bExperimental Treatment2 Interventions
All Cycles = 21 days
Binimetinib, by mouth (orally), at the best dose found in Phase 1 of the study, twice a day, continuously.
Pembrolizumab, by vein (intravenously), at a dose of 200 mg on Day 1 of every cycle.
Group II: Phase 1Experimental Treatment2 Interventions
Cycle 1 = 28 days and Cycle 2 and Future Cycles = 21 days
Binimetinib, by mouth (orally): Level 1: 45 mg, twice a day, continuously; Level -1: 30 mg, twice a day, continuously; Level -2: 30 mg, twice a day, for Days 1-14 of each cycle only
Pembrolizumab, by vein (intravenously), at a dose of 200 mg on Day 8 of Cycle 1, then Day 1 of Cycle 2 and future cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
2018
Completed Phase 3
~1100
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,140 Total Patients Enrolled
Natasha Leighl, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I have another cancer that is getting worse or was treated in the last year.I can take pills and don't have major stomach or bowel issues affecting drug absorption.You have a history of muscle or nerve problems that cause high levels of creatine phosphokinase (CK).I have been treated with specific immune therapy or a MEK inhibitor before.You have a device in your heart to help with its rhythm.You plan to start intense exercise after starting the study treatment.I am fully active or restricted in physically strenuous activity but can do light work.I have stable brain metastases and haven't needed steroids for 14 days.My organs are functioning well.I have a history of Hepatitis B or active Hepatitis C.I have been diagnosed with HIV.I've had heart issues or procedures in the last 6 months or have cancer that has spread to my heart.I have a history of serious heart rhythm problems that are not under control.I have a risk for abnormal heart rhythms or my heart's electrical cycle is longer than normal.I have moderate to severe heart failure.My lung cancer is advanced, not small cell, and tests high for PDL-1 without certain gene changes.I have a history or risk of blocked veins in my eye.I have an active, untreated TB infection.My high blood pressure does not improve with medication.I have a history of eye disease that affects my retina.I have had or currently have lung inflammation treated with steroids.You have had a severe allergic reaction to pembrolizumab or similar medications.I am pregnant (positive pregnancy test).I have not received a live vaccine in the last 30 days.I have been diagnosed with Gilbert's syndrome.I am currently being treated for an infection.I can provide a sample of my tumor for genetic testing.I had radiotherapy over 2 weeks ago, with no ongoing side effects and haven't needed steroids.I have an autoimmune disease treated with medication in the last 2 years.My cancer can be measured by tests.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1
- Group 2: Phase 1b
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has regulatory approval been granted to the drug Pembrolizumab?
"As a Phase 1 trial, there is limited evidence to confirm the efficacy and safety of Pembrolizumab. Consequently, our team has assigned it a score of 1 on its scale from 1-3."
Answered by AI
How many individuals will be selected to participate in this research?
"Correct. The information hosted on clinicaltrials.gov attests that this trial is currently recruiting patients, with the initial posting occuring on September 20th 2019 and most recent update being May 9th 2022. Specifically, 40 participants need to be recruited from one medical centre."
Answered by AI
What medical issues is Pembrolizumab employed to address?
"Pembrolizumab is well-known for its efficacy in treating malignant neoplasms. It has also been used to manage advanced cases of melanoma, high microsatellite instability, and chemotherapy resistance."
Answered by AI
What research has been done on the efficacy of Pembrolizumab?
"At present, there are 1,011 clinical trials exploring the potential of Pembrolizumab; with 124 of these initiatives in Phase 3. Although Rochester, Minnesota is a frequent location for such studies due to its abundance of research centres, 38560 sites across the globe have hosted similar experiments."
Answered by AI
Are there any vacancies for this investigation that participants can take advantage of?
"According to the logs on clinicaltrials.gov, this research trial is still recruiting volunteers. The investigation was initially published on September 20th 2019 and last modified on May 9th 2022."
Answered by AI
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