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Taxane
Pembrolizumab + Lenvatinib vs. Docetaxel for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has PD during/after platinum doublet chemotherapy for metastatic disease.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention but before randomization.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~79 months
Awards & highlights
Study Summary
This trial will compare the effects of two cancer treatments - pembrolizumab and lenvatinib vs. docetaxel - on overall survival and progression-free survival in patients with metastatic non-small cell lung cancer who have progressed after initial platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody.
Who is the study for?
This trial is for adults with metastatic NSCLC who've seen their disease progress after platinum chemotherapy and anti-PD-1/PD-L1 therapy. They should be relatively healthy (ECOG 0 or 1), not pregnant, willing to use contraception, have manageable blood pressure, good organ function, and no severe allergies to the study drugs.Check my eligibility
What is being tested?
The trial tests if pembrolizumab combined with lenvatinib improves survival compared to docetaxel in patients whose NSCLC has worsened despite previous treatments. It's a randomized study measuring overall survival and time without disease progression.See study design
What are the potential side effects?
Pembrolizumab can cause immune-related side effects like inflammation of organs, skin reactions, and fatigue. Lenvatinib may lead to high blood pressure, tiredness, reduced appetite among others. Docetaxel can result in low white blood cell count increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer progressed despite platinum-based chemotherapy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have provided a sample of my tumor for PD-L1 testing from before I started immunotherapy.
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I have a tumor that can be measured by CT or MRI.
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My lung cancer is confirmed to be at stage IV.
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My cancer progressed despite treatment with a specific immune therapy.
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My blood pressure is ≤150/90 mm Hg and stable for the last week.
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My cancer progressed after starting treatment with an anti-PD-1/PD-L1 drug.
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My cancer is not suitable for EGFR, ALK, or ROS1 therapy due to specific genetic test results.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~79 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~79 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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Secondary outcome measures
Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score
Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
+12 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
3Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab+LenvatinibExperimental Treatment2 Interventions
Participants receive pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab will be administered for up to 35 treatment cycles (~2 years). Lenvantinib will be administered until progressive disease or unacceptable toxicity.
Group II: Lenvatinib MonotherapyExperimental Treatment1 Intervention
Participants receive lenvatinib at 24 mg, QD via oral capsule. Lenvantinib will be administered until progressive disease or unacceptable toxicity.
Group III: DocetaxelActive Control1 Intervention
Participants receive docetaxel at 75 mg/m^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel will be administered 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 LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,149 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,598 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,400 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active tuberculosis.My cancer progressed despite platinum-based chemotherapy.My scans show my tumor is affecting a major blood vessel.I have been treated with lenvatinib alone or with an anti-PD-1/PD-L1 drug.I have a severe fistula.I have received an organ or tissue transplant from another person.I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use contraception or abstain from sex as required.I had another cancer but have been free of it for 3 years after treatment.I am fully active or restricted in physically strenuous activity but can do light work.I have cancer that has spread to my brain or surrounding membranes.I agree to follow the required birth control or abstinence guidelines while on treatment.I have had significant coughing up of blood or tumor bleeding in the last 2 weeks.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I have been diagnosed with HIV.I have been treated for an autoimmune disease in the last 2 years.I have a stomach or intestine condition that affects how I absorb medications.I have a history of hepatitis B or active hepatitis C.I have had lung inflammation treated with steroids or currently have lung disease.My organs are functioning well.I have had serious heart problems in the last year.I have provided a sample of my tumor for PD-L1 testing from before I started immunotherapy.I have recovered from any major surgery or high-dose radiation therapy.I have a tumor that can be measured by CT or MRI.I have provided a recent tissue sample from a biopsy of a tumor that was not previously treated with radiation.My lung cancer is confirmed to be at stage IV.I am currently being treated for an infection.My cancer progressed despite treatment with a specific immune therapy.My blood pressure is ≤150/90 mm Hg and stable for the last week.My cancer progressed after starting treatment with an anti-PD-1/PD-L1 drug.My cancer is not suitable for EGFR, ALK, or ROS1 therapy due to specific genetic test results.I haven't had recent radiotherapy or significant lung radiation in the past 6 months.I have been treated with docetaxel alone or with other treatments.I have not received a live vaccine in the last 30 days.I can be treated again with the same anti-PD-L1 therapy I had before.You are allergic to any of the ingredients in lenvatinib or docetaxel.You have a severe allergy to pembrolizumab or any of the ingredients in it.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab+Lenvatinib
- Group 2: Docetaxel
- Group 3: Lenvatinib Monotherapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
What other clinical trials has Pembrolizumab been involved in?
"Pembrolizumab is being studied in 1381 active clinical trials, with 254 of those studies in Phase 3. Though the majority of these research initiatives are based out of Houston, Texas, 56870 locations worldwide are running some form of Pembrolizumab trial."
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