Efficacy and Safety of Pembrolizumab With Lenvatinib vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer and Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy

This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with an anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

Status:

Recruiting

Phase 3 Icon

Trial Phase

The investigational drug is being studied in a large group of patients to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the investigational drug to be used safely.

Eligibility

About the Trial

All patients who enroll in the trial will receive medication while on the study.

  • ~44% will receive pembrolizumab along with lenvatinib
  • ~44% will receive docetaxel
  • ~11% will receive lenvatinib alone

Both you and the study doctor will know which group you are in.

Trial Purpose
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US Trial Locations

Clinical trial sites are places such as hospitals or clinics where the trial is being conducted.

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National Trial Reference Number

NCT03976375 Read More at clinicaltrials.gov

What Can You Do Next?

If you would like to learn about this clinical trial or see if you can participate, you can:

Contact Our Trial Info Center

To learn more, call 1-888-577-8839

Discuss With Your Doctor

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Tip: To help with understanding of some clinical terms used on the page, select an underlined term to see what they mean.

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Condition

The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Metastatic Non-Small Cell Lung Cancer

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with an anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

Important information

Participating in a clinical trial is an important decision. Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.

Trial Locations

    Location
    Status
  • Bakersfield, California, United States, 93309
    Recruiting
  • Orange City, Florida, United States, 32763
    Recruiting
  • Baltimore, Maryland, United States, 21239
    Recruiting
  • Baltimore, Maryland, United States, 21237
    Recruiting
  • Portland, Oregon, United States, 97227
    Recruiting
  • Billings, Montana, United States, 59101
    Recruiting

How to Learn More

When speaking to your doctor, please have the trial reference number available. You can also call 1-888-577-8839 for more information.

Print or email this page.

Trial reference number

A unique identification code given to each clinical trial registered on clinicaltrials.gov.

Leap number

A unique identification code used by the sponsor to identify a specific trial.
Leap-7902-008

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
A Phase 3, Multicenter, Randomized, Open-label Trial to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Docetaxel in Previously Treated Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (Anti-PD-1/PD-L1 Inhibitor) (LEAP-008)

Call 1-888-577-8839 to contact our trial information center

Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.