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Trametinib + Pembrolizumab for Lung Cancer
Study Summary
This trial is testing the side effects and best dose of trametinib when given with pembrolizumab to treat patients with non-small cell lung cancer that has returned or spread.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 206 Patients • NCT02034110Trial Design
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Who is running the clinical trial?
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- I have had specific immune therapy and my cancer did not respond well.I haven't had monoclonal antibody therapy in the last 4 weeks or have recovered from its side effects.My kidney function, measured by creatinine, is within the normal range.My NSCLC is advanced, cannot be surgically removed, and has been treated before.Your platelet count should be at least 100,000 per cubic millimeter.I can take pills and don't have major gut issues affecting medicine absorption.I have received at least 2 doses of a PD-1/PD-L1 inhibitor.My cancer has worsened after treatment with a specific immunotherapy.My cancer has worsened within 12 weeks after my last anti PD-1/PD-L1 treatment.I haven't used any experimental drugs or treatments in the last 4 weeks.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I am currently being treated for an infection.I have active hepatitis B or C.I have or am at risk for blocked blood vessels in my eye.I am not on medication that affects heart rhythm or can switch before treatment starts.I have a tumor or lymph node that can be measured and meets size requirements.My blood clotting time is normal or managed with medication.I am not pregnant and agree to use birth control during and up to 120 days after the study.I have previously been treated with a MEK inhibitor.I stopped an immune therapy due to a severe side effect.I haven't had chemotherapy or radiation recently, or I've recovered from their side effects.I have another cancer besides the one being studied, but it's either not growing or doesn't need treatment right now, except for certain skin cancers or treated cervical cancer.I have stable brain metastases and haven't used steroids in the last 7 days.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have lung issues that needed steroids for treatment.I have fluid buildup in my abdomen or chest but am stable after treatment.I do not have significant heart problems or a history of serious heart conditions.I have been tested for EGFR and ALK before joining, and if positive, I've had specific treatments but my cancer progressed.I am fully active or can carry out light work.My hemoglobin level is at least 9 g/dL without recent treatments to increase it.My blood clotting time is normal or managed if I'm on blood thinners.My tumor can be biopsied, and I agree to have this done before starting the treatment plan.I have not received a live vaccine in the last 30 days.I have been diagnosed with HIV.My liver enzymes are within the required range for my condition.Your absolute neutrophil count is at least 1.5 x 10^9/L or 1500/mm^3.Your bilirubin levels in the blood should not be too high.I stopped my standard cancer treatment because of severe side effects.
- Group 1: Treatment (trametinib, pembrolizumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does this research endeavor have any open spots for participants?
"This research is no longer actively recruiting participants; it was initially posted on February 3rd 2018 and had its most recent update on July 5th 2022. For those still looking for a trial, there are 4155 clinical studies currently accepting patients with lung cancer and 1042 investigating the use of Trametinib."
What are the common applications of Trametinib?
"Trametinib is generally prescribed to treat cancerous growths. It can also provide relief for those with advanced melanoma, microsatellite instability high tumours, and post-chemotherapy progression of diseases."
How many volunteers are contributing to this medical experiment?
"This medical trial has closed its recruitment process. The period of enrollment for this clinical experiment was between February 3rd 2018 and July 5th 2022. If you are looking to get involved in a similar study, there are currently 4155 trials related to lung cancer requiring participants and 1042 trials handling Trametinib that accept volunteers."
Are there any other trials that have investigated the effects of Trametinib?
"Currently, a substantial number of Trametinib trials are in operation - 1,042 to be exact. Of those studies, 128 have reached Phase 3 and each require 41384 locations to run the trial properly. Rochester Minnesota serves as one of the primary research hubs for this medication's clinical assessment."
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