Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab With or Without Lenvatinib as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer

The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer. The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.

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 in combination with cisplatin with pemetrexed or carboplatin with pemetrexed*
  • 50% will receive pembrolizumab and placebo in combination with cisplatin with pemetrexed or carboplatin with pemetrexed*

* Your doctor will decide which chemotherapy treatment (cisplatin with pemetrexed or carboplatin with pemetrexed) is best for you    

Trial Purpose
7

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

NCT03829319 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.
Nonsquamous 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 pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer. The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.

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
  • Fort Lauderdale, Florida, United States, 33308
    Recruiting
  • Johnson City, New York, United States, 13790
    Recruiting
  • Corvallis, Oregon, United States, 97330
    Recruiting
  • Germantown, Tennessee, United States, 38138
    Recruiting
  • Philadelphia, Pennsylvania, United States, 19107
    Recruiting
  • Detroit, Michigan, United States, 48202
    Recruiting
  • Fargo, North Dakota, United States, 58122
    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-7902-006

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, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)

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.