Conditions
Non-Small Cell Lung Cancer
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.
NATIONAL TRIAL REFERENCE NUMBER
NCT03924869
EudraCT
2018-004320-11
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18+
Sex
All
About The Trial
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
Trial 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 doctors’ offices.
Trial start and end dates
- Actual study start date 25 June 2019
- Estimated primary completion date 11 April 2025
- Estimated study completion date 1 July 2026
Trial locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about