Trial results for the study NCT04967417, investigating pembrolizumab with standard cytotoxic chemotherapy in treatment-naive non-small cell lung cancer (NSCLC) patients with asymptomatic brain metastases, were posted on ClinicalTrials.gov on 2025-05-09. The study reported an intracranial objective response rate (iORR) in 6 participants with non-squamous NSCLC, while 0 participants with squamous NSCLC showed an iORR in the initial reported count.
Background
The study NCT04967417 investigated the use of pembrolizumab in combination with platinum doublet chemotherapy for patients with advanced non-small cell lung cancer (stage IV) who also presented with asymptomatic brain metastases. The trial specifically focused on treatment-naive patients.
Trial design
The study NCT04967417 was a Phase 2, single-center, open-label, single-arm study. It enrolled a total of 13 participants with advanced non-small cell lung cancer (stage IV) and asymptomatic brain metastases. Participants received a combination of pembrolizumab 200mg plus a platinum doublet, specifically pemetrexed, carboplatin, and pembrolizumab for non-squamous histology, or paclitaxel, carboplatin, and pembrolizumab for squamous histology. While specific primary endpoints were not detailed in the provided data, key outcome measurements included Intracranial Objective Response Rate (iORR), Progression Free Survival (PFS), and Overall Survival (OS).
Key results
The trial enrolled a total of 13 participants. Key outcome measurements were reported by histology subtype:
- For Intracranial Objective Response Rate (iORR):
- Among participants with Non-squamous Cell Carcinoma, counts of 6 participants, 5 participants, and 0 participants were reported.
- Among participants with Squamous Cell Carcinoma, counts of 0 participants, 0 participants, 1 participant, and 1 participant were reported.
- For Progression Free Survival (PFS):
- The median PFS for Non-squamous Cell Carcinoma was 7.23 Months.
- The median PFS for Squamous Cell Carcinoma was 7.7 Months.
- For Overall Survival (OS):
- The median OS for Non-squamous Cell Carcinoma was 10.45 Months.
- The median OS for Squamous Cell Carcinoma was 12.45 Months.
What this means
The results from this Phase 2 study provide initial insights into the combination of pembrolizumab with platinum doublet chemotherapy for treatment-naive patients with non-small cell lung cancer and asymptomatic brain metastases. The reported counts for intracranial objective response rate suggest a differential activity based on histology, with multiple instances of response observed in the non-squamous cohort, while responses were less frequent or absent in the squamous cohort in this small study. The median progression-free survival and overall survival figures offer preliminary data on the regimen's potential in this challenging patient population. These findings, from a study with 13 participants, highlight the need for further investigation in larger, more definitive trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04967417, titled "Pembrolizumab With Standard Cytotoxic Chemotherapy in Treatment Naive NSCLC Patients With Asymptomatic Brain Metastases," were posted on 2025-05-09 on clinicaltrials.gov.