A Phase 3 clinical trial (NCT03867175) investigating pembrolizumab, both alone and in combination with stereotactic body radiation therapy (SBRT), for patients with Stage IV non-small cell lung cancer, completed its primary phase on April 21, 2025. The trial enrolled a total of 5 participants.
Background
Pembrolizumab is an immunotherapy agent, a monoclonal antibody designed to help the body's immune system attack cancer cells and interfere with their ability to grow and spread. This trial specifically focused on its use in patients diagnosed with Stage IV non-small cell lung cancer.
Trial design
The study, titled "Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer" (NCT03867175), was a Phase 3 trial. It enrolled a total of 5 participants with Stage IV non-small cell lung cancer or metastatic lung cancer. The trial compared two treatment arms: Arm 1 involved stereotactic body radiation therapy (SBRT) combined with pembrolizumab, while Arm 2 involved pembrolizumab only after first-line systemic therapy.
Key results
The trial reported the following participant counts for various outcomes:
- For "Number of Participants With Progression-free Survival (PFS) After Completion of First Line Standard of Care Systemic Therapy": 1 participant in the Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab group and 0 participants in the Arm 2 Pembrolizumab Only group.
- For "Number of Participants With Overall Survival": 1 participant in the Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab group and 0 participants in the Arm 2 Pembrolizumab Only group.
- For "Number of Participants With Progression": 1 participant in the Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab group and 0 participants in the Arm 2 Pembrolizumab Only group.
- For "Number of Participants to Have a Rate of Failure": 1 participant in the Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab group and 0 participants in the Arm 2 Pembrolizumab Only group.
- For "Number of Participants With New Sites of Disease": 1 participant in the Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab group and 0 participants in the Arm 2 Pembrolizumab Only group.
- For "Number of Participants With Adverse Events": 4 participants in the Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab group and 1 participant in the Arm 2 Pembrolizumab Only group.
What this means
The primary completion of this Phase 3 trial indicates that the study has reached its planned endpoint for data collection. However, with an enrollment of only 5 participants, the reported outcome counts are based on an extremely limited sample size. These preliminary counts cannot be used to draw statistically significant conclusions regarding the efficacy or safety profile of pembrolizumab with or without SBRT in Stage IV non-small cell lung cancer. Further research with larger participant cohorts would be necessary to establish meaningful clinical insights.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The completion status for study NCT03867175, titled "Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer," was posted on 2025-04-21 on clinicaltrials.gov.