Trial results for a Phase 2 study (NCT05691829) investigating pembrolizumab with non-ablative radiation in previously untreated patients with Stage IV NSCLC were posted on ClinicalTrials.gov on 2025-07-29. The study reported an objective response rate of 38.46% among participants. This trial was terminated, with an enrollment of 19 participants.
Trial design
The study (NCT05691829) was a Phase 2 trial that enrolled 19 participants with Stage IV NSCLC. The study investigated pembrolizumab in combination with chemotherapy and non-ablative radiation. Its purpose was to evaluate if low dose radiation could improve results from standard treatment with pembrolizumab and chemotherapy in this patient population. The trial was terminated.
Key results
The trial reported several key measurements for untreated patients with Stage IV NSCLC:
- The percentage of participants with a best overall response of complete response (CR) or partial response (PR) by the end of treatment cycle 4 was 30.77%.
- The percentage of participants with an objective response was 38.46%.
- Median progression-free survival (PFS) at final follow-up was 42.86 weeks.
- Median overall survival (OS) at final follow-up was 51.57 weeks.
What this means
The results from this Phase 2 trial provide initial data on the use of pembrolizumab with non-ablative radiation and chemotherapy in previously untreated patients with Stage IV NSCLC. The observed objective response rate of 38.46% and median overall survival of 51.57 weeks offer insights into potential efficacy. However, the trial's termination and small enrollment of 19 participants mean these findings should be interpreted with caution and require further investigation in larger studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05691829, titled "Immunotherapy With Non-Ablative Radiation in Previously Untreated Patients With Stage IV NSCLC," were posted on 2025-07-29 on clinicaltrials.gov.