Efficacy and Safety Study of Pembrolizumab With or Without Lenvatinib in Adults With Programmed Cell Death-Ligand 1 -Positive Treatment-naïve Non-small Cell Lung Cancer

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).

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.

  • 50% will receive pembrolizumab and lenvatinib
  • 50% will receive pembrolizumab and placebo

Neither you nor the study doctor will know what you are getting. In case of a health emergency, the study doctor can get this information.

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.

See Locations

National Trial Reference Number

NCT03829332 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

Print this page or Email it to your doctor to discuss at your next visit

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.
Non-small Cell Lung Cancer

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).

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
  • Anchorage, Alaska, United States, 99503
    Recruiting
  • Traverse City, Michigan, United States, 49684
    Recruiting
  • Bakersfield, California, United States, 93309
    Recruiting
  • Fort Wayne, Indiana, United States, 46845
    Recruiting
  • Saint Louis Park, Minnesota, United States, 55426
    Recruiting
  • Billings, Montana, United States, 59101
    Recruiting
  • Marietta, Georgia, United States, 30060
    Recruiting
  • Annapolis, Maryland, United States, 21401
    Recruiting
  • La Jolla, California, United States, 92037
    Recruiting
  • Greensboro, North Carolina, United States, 27403
    Recruiting
  • Orlando, Florida, United States, 32803
    Recruiting
  • Chandler, Arizona, United States, 85224
    Recruiting
  • Portland, Oregon, United States, 97239
    Recruiting
  • Lexington, Kentucky, United States, 40536
    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-7902-007

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, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Non-small Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)

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.