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Monoclonal Antibodies

Pembrolizumab + Trametinib for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Jonathan Riess
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progressive disease after platinum containing chemotherapy
Histologically or cytologically confirmed non-small cell lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a combination of two drugs to treat patients with lung cancer that has spread to other parts of the body. The drugs are designed to interfere with the ability of tumor cells to grow and spread.

Who is the study for?
This trial is for adults with Stage IV non-small cell lung cancer (NSCLC) that has spread and contains a KRAS mutation. Participants must have seen their disease progress after chemotherapy, be able to take pills, and perform daily activities with little or no assistance. They should not have other active cancers, serious heart conditions, infections needing treatment, recent vaccinations with live vaccines, HIV/Hepatitis B/C, or certain eye diseases.Check my eligibility
What is being tested?
The study tests the combination of Pembrolizumab (a monoclonal antibody that may block cancer growth) and Trametinib (an enzyme inhibitor that could stop tumor cells from growing). The goal is to see if taking these two drugs together offers better results than current treatments for NSCLC patients with KRAS mutations.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs like lungs or intestines (pneumonitis), skin rash, liver problems; fatigue; nausea; changes in blood pressure; heart issues such as arrhythmias; and potential risks during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has worsened after treatment with platinum-based chemotherapy.
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My lung cancer diagnosis was confirmed through lab tests.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can swallow and keep down pills.
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I am not pregnant and will use birth control.
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My lung cancer is at stage IV or has spread to other parts.
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My tumor has a KRAS mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose-limiting toxicity (DLT) of pembrolizumab and trametinib per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0
Secondary outcome measures
Heart rate
Progression-free survival (PFS)
Other outcome measures
Changes in PD-L1 expression assessed by immunohistochemistry and immunofluorescence
Functional assessment of tumor infiltrating immune cells assessed by immunophenotyping
Local tumor cytokine/chemokine signatures assessed by Luminex
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (pembrolizumab, trametinib)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Beginning on day 1 of course 2, patients also receive trametinib PO daily. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (trametinib, pembrolizumab)Experimental Treatment2 Interventions
Patients receive trametinib PO daily. Beginning on day 1 of course 2, patients also receive pembrolizumab IV over 30 minutes. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Trametinib
2014
Completed Phase 2
~1550

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,356 Total Patients Enrolled
University of California, DavisLead Sponsor
913 Previous Clinical Trials
4,709,728 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,896 Previous Clinical Trials
5,062,703 Total Patients Enrolled

Frequently Asked Questions

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

What is the upper limit of participants in this clinical investigation?

"Unfortunately, enrolment for this particular trial has been suspended. Initially posted on June 26th 2018, the clinical trial was last edited on June 1st 2022 and is no longer searching for patients. However, 4166 studies are still actively recruiting those with metastatic non-squamous non-small cell lung carcinoma whereas 1042 trials require participants to take pembrolizumab."

Answered by AI

What other investigations have been conducted with regards to Pembrolizumab?

"Currently, there are 1042 active research studies involving Pembrolizumab with 128 of those trials currently in their final phase. The vast majority of these clinical experiments are based out of Boston, MA; however, the drug is being trialled across 41388 sites worldwide."

Answered by AI

Is it possible to enroll in this experiment at the present time?

"As per the latest update on clinicaltrials.gov, this medical trial no longer requires participants. It was first posted in late June of 2018 and was most recently updated at the start of June 2022. Fortunately, there are presently 5208 other studies recruiting patients to take part in their research endeavours."

Answered by AI

Has Pembrolizumab received authorization from the Food and Drug Administration?

"Due to there being limited data on the efficacy and safety of Pembrolizumab, our team has rated it a 1 on a scale from 1 to 3."

Answered by AI

What conditions are generally treated with Pembrolizumab?

"Pembrolizumab is a common treatment prescribed for malignant neoplasms, as well as more specific illnesses such as unresectable melanoma, microsatellite instability high, and chemotherapy-resistant cases."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab and Trametinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer and KRAS Gene Mutations
2018. "Pembrolizumab and Trametinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer and KRAS Gene Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03299088.
~2 spots leftby May 2025
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