Efficacy and Safety Study of Stereotactic Body Radiotherapy With or Without Pembrolizumab in Adults With Medically Inoperable Stage I or IIA Non-Small Cell Lung Cancer

The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC). The primary study hypotheses are: 1. SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and 2. SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.

Status:

Not yet recruiting

Phase 3 Icon

Trial Phase

The investigational immunotherapy 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 immunotherapy to be used safely.

Eligibility

About the Trial

Trial Opening to Recruitment mid-June 2019

All patients who enroll in the trial will receive treatment while on the study. You will have an equal chance of receiving one of the following treatments:

  • 50% will receive SBRT and pembrolizumab
  • 50% will receive SBRT 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.

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National Trial Reference Number

NCT03924869 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 efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC). The primary study hypotheses are: 1. SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and 2. SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.

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.

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.

Keynote number

A unique identification code used by the sponsor to identify a specific trial.
Keynote-867

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 Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Medically Inoperable Stages I or IIA Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)

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.