Trial results for a Phase 2 study (NCT03242915) investigating pembrolizumab plus chemotherapy (carboplatin and pemetrexed) in patients with non-small cell lung cancer (NSCLC) with targetable genetic alterations were posted on ClinicalTrials.gov on 2025-05-30. The study showed that 46% of patients with EGFR+ NSCLC responded to treatment after progression on targeted agents, with a median progression-free survival of 8.3 months.
Background
The study aimed to investigate the efficacy of adding pembrolizumab to carboplatin and pemetrexed in patients with EGFR-mutation-positive NSCLC or other genetic alterations who had experienced disease progression following appropriate targeted therapies. Investigators hypothesized that this combination would enhance treatment efficacy in this patient population.
Trial design
The Phase 2 study (NCT03242915) enrolled 33 participants with non-small cell lung cancer (NSCLC) who had targetable genetic alterations and had progressed on prior targeted agents. Participants received a combination of pembrolizumab, carboplatin, and pemetrexed. The primary outcomes for this study were not detailed in the posted results.
Key results
The trial reported the following key measurements for patient response, progression-free survival (PFS), and overall survival (OS) in specific NSCLC subgroups:
- For "The Percentage of Patients That Respond to Treatment":
- In EGFR+ NSCLC patients, 46% of patients responded to treatment.
- In ALK+ NSCLC patients, 29% of patients responded to treatment.
- For "Progression Free Survival (PFS) Time":
- The median PFS for EGFR+ NSCLC patients was 8.3 Months.
- The median PFS for ALK+ NSCLC patients was 2.9 Months.
- For "Overall Survival (OS) Time":
- The median OS for EGFR+ NSCLC patients was 22.2 Months.
- The median OS for ALK+ NSCLC patients was 2.9 Months.
What this means
These Phase 2 results provide insights into the efficacy of pembrolizumab combined with chemotherapy in NSCLC patients with specific genetic alterations who have progressed on targeted therapies. The observed response rates and survival times suggest varying benefits across different genetic subgroups, with EGFR+ NSCLC patients showing a higher response rate and longer median PFS and OS compared to ALK+ NSCLC patients in this small study. These findings may inform future research directions for combination therapies in this challenging patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03242915, titled "Pembrolizumab Plus Chemotherapy in NSCLC With Targetable Genetic Alterations After Progression on Targeted Agents," were posted on 2025-05-30 on clinicaltrials.gov.