Trial results for pembrolizumab in patients with Non-Small Cell Lung Cancer (NSCLC) and a performance status of 2 were posted on ClinicalTrials.gov on 2025-02-10. The study reported a median overall survival time of 9.8 months.
Background
Pembrolizumab (Keytruda) was investigated for its safety and tolerability in the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients with a performance status of 2. The study aimed to determine if the drug was safe and tolerable at the selected dose for this specific patient population.
Trial design
This completed Phase 2 trial (NCT02733159) enrolled 62 participants with Non-Small Cell Lung Cancer. The study's objective was to assess the safety and tolerability of pembrolizumab at a selected dose in patients with a performance status of 2. All enrolled patients received pembrolizumab.
Key results
Key results from the trial include:
- For Toxicity Rate, counts of participants were 18 and 42.
- For Durable Clinical Benefit, counts of participants were 22 and 38.
- For Objective Response, counts of participants were 44 and 16.
- The median Time to Progression was 11.9 months (90% Confidence Interval).
- The median Progression-free Survival Time was 4.39 months (90% Confidence Interval).
- The median Overall Survival Time was 9.8 months (90% Confidence Interval).
- The median Duration of Objective Response was 14.6 months (90% Confidence Interval).
- The median Duration of Stable Disease was 4.39 months (90% Confidence Interval).
What this means
The reported median overall survival of 9.8 months and median progression-free survival of 4.39 months provide initial insights into the potential efficacy of pembrolizumab in this patient population. The study's focus on safety and tolerability, alongside these outcome measures, contributes to understanding the drug's profile for patients with Non-Small Cell Lung Cancer and a performance status of 2.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02733159, titled "Pembrolizumab in Patients With Non-Small Cell Lung Cancer and a Performance Status 2," were posted on 2025-02-10 on clinicaltrials.gov.