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:

  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.
Learn More on ClinicalTrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT03924869

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

About The Study

All patients who enrol 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 Phase Icon

Phase 3

Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). 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 25 June 2019
  • Estimated primary completion date 11 April 2025
  • Estimated study completion date 1 July 2026

Eligibility

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

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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

Locations provided may not reflect the most current site information. Please call the number provided in the location results to confirm.