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 unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).

The primary study hypotheses are:

SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and
SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT03924869

When speaking to your doctor, please have the trial identifier number available.

About The Trial

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.

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Phase 3

Tests the medicine or vaccine in approximately 1,000 to 5,000 volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices.

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Dates

  • Actual study start date June 25, 2019
  • Estimated primary completion date April 11, 2025
  • Estimated study completion date July 1, 2026

Eligibility

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Conditions

Non-small Cell Lung Cancer

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Age Range

18 - No Age Maximum

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Sex

All

Trial locations

What Can You Do Next?

If you think this trial might be a fit and are interested in participating, take the next step to see if you are eligible.

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Discuss With Your Doctor

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

CLINICALTRIALS.GOV IDENTIFIER:

NCT03924869

When speaking to your doctor, please have the trial identifier number available.

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.