Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Pembrolizumab + Lenvatinib for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a histologically or cytologically confirmed diagnosis of NSCLC
Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week before randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 25 months
Awards & highlights
Study Summary
This trial will study whether adding lenvatinib to pembrolizumab improves outcomes for people with NSCLC whose tumors have a high PD-L1 score.
Who is the study for?
Adults with a specific type of advanced lung cancer (Stage IV NSCLC) that expresses a protein called PD-L1 can join this trial. They should not have had previous systemic cancer treatments, must be expected to live at least 3 more months, and need to have stable blood pressure and good organ function. Women who are pregnant or breastfeeding cannot participate, and all participants must agree to use effective contraception.Check my eligibility
What is being tested?
The study is testing the effectiveness of combining two drugs: Pembrolizumab (an immunotherapy drug) and Lenvatinib (a targeted therapy), versus using Pembrolizumab alone with a placebo for Lenvatinib in patients who haven't been treated before for their lung cancer. The main goals are to see if the combination works better for slowing down the disease's progression and improving survival rates.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, nausea, decreased appetite, weight loss, inflammation of organs like lungs or intestines (which could cause symptoms such as coughing or diarrhea), liver problems which might show up as yellow skin or eyesight changes; also risks related to immune system reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer diagnosis was confirmed through lab tests.
Select...
My blood pressure is ≤150/90 mm Hg and my medication hasn't changed in the last week.
Select...
My cancer shows a specific protein in at least 1% of the cells.
Select...
My lung cancer is at stage IV.
Select...
My lung cancer diagnosis was confirmed through lab tests.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My lung cancer is at stage IV.
Select...
My cancer shows PD-L1 in more than 1% of cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 25 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 25 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Secondary outcome measures
Pain
Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score
Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
+10 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
Active Control
Group I: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
Group II: Pembrolizumab + PlaceboActive Control2 Interventions
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,199 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,948 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,397 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for an infection.I have an autoimmune disease but only take replacement therapies like insulin.My lung cancer diagnosis was confirmed through lab tests.You have a disease that can be measured using a specific medical guideline.I have received a transplant from another person.I had another cancer but have been free of it for over 3 years, or it was a minor skin, bladder, or in situ cancer.My blood pressure is ≤150/90 mm Hg and my medication hasn't changed in the last week.I haven't had recent radiotherapy or high-dose lung radiation in the past 6 months.I am not pregnant or breastfeeding, and either cannot become pregnant or am using reliable birth control.I have had chemotherapy or targeted therapy for my advanced lung cancer.My cancer shows a specific protein in at least 1% of the cells.I have coughed up bright red blood recently.I haven't had major heart problems like heart failure, heart attack, or stroke in the last year.I have not had a live vaccine in the last 30 days.I am a male who will not have sex or will use birth control during and for 7 days after treatment.My lung cancer is at stage IV.I have a history of hepatitis B or an active hepatitis C infection.You are expected to live for at least 3 more months.I have been taking more than 10 mg of steroids daily within the last week.My lung cancer diagnosis was confirmed through lab tests.I am still recovering from major surgery complications.My blood pressure is ≤150/90 mm Hg and stable on current medications.I have an active case of tuberculosis.You have a disease that can be measured using specific guidelines.You have a history of being infected with HIV.I have had pneumonitis that needed steroids or currently have lung disease.I have untreated brain metastases or carcinomatous meningitis.My scans show my tumor is affecting a major blood vessel.I have a severe fistula.I am fully active or restricted in physically strenuous activity but can do light work.I have not had major surgery in the last 3 weeks.My organs are functioning well.My lung cancer is at stage IV.I have had a severe allergic reaction to monoclonal antibody treatments or am allergic to lenvatinib or pembrolizumab.I have an immune system disorder or have been on immune-weakening medication recently.I have been treated with specific immune system targeting drugs or lenvatinib.My cancer shows PD-L1 in more than 1% of cells.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Lenvatinib
- Group 2: Pembrolizumab + Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What are the main functions of Pembrolizumab?
"Pembrolizumab can be used to treat cancerous growths, malignant neoplasms, and unresectable melanoma."
Answered by AI
Is this trial easily accessible to many potential participants in this city?
"There are 23 clinical trial sites currently recruiting patients for this study. A few examples of the locations include Windsor, La Jolla, and Orlando. When selecting a location to participate in the trial, it is important to choose the one that is closest to your home to minimize travel."
Answered by AI
Has the Food and Drug Administration greenlit Pembrolizumab?
"Pembrolizumab falls into Phase 3 of clinical trials, meaning that there is efficacy data as well as multiple rounds of safety data, and is thus estimated to be a 3 on our Power scale."
Answered by AI
What other researchers have looked into Pembrolizumab?
"City of Hope first studied pembrolizumab in 2010. Since then, 298 completed studies have been conducted. Right now, there are 1077 clinical trials in progress, a significant portion of which are based in Windsor, Canada."
Answered by AI
What are researchers looking to learn from this clinical trial?
"The primary outcome of this study is overall survival (OS), which will be measured over a period of up to approximately 25 months. Secondary outcomes include time to true deterioration (TTD) based on change from baseline in the composite endpoint of cough (EORTC QLQ-LC13 item 31), chest pain (EORTC QLQ-LC13 item 40), or dyspnea (EORTC QLQ-C30 item 8), which is defined as TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in"
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Alaska Clinical Research Center ( Site 0511)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger