Pembrolizumab/Ramucirumab Combination Shows 0% ORR in EGFR Mutant NSCLC Trial

Trial results for the Phase 2 study (NCT04120454) investigating pembrolizumab in combination with ramucirumab for EGFR mutant recurrent or metastatic non-small cell lung cancer were posted on ClinicalTrials.gov on 2025-07-11. The study reported an overall response rate of 0% for the combination treatment.

Background

This Phase 2 trial explored the combination of pembrolizumab and ramucirumab for the treatment of EGFR mutant non-small cell lung cancer that is recurrent or metastatic. Pembrolizumab is an immunotherapy, while ramucirumab is described as having anti-angiogenic and pleotropic immunomodulatory effects, potentially synergizing with an anti-PD-1 agent.

Trial design

The Phase 2 study (NCT04120454), titled "Ramucirumab and Pembrolizumab for the Treatment of EGFR Mutant Recurrent or Metastatic Non-small Cell Lung Cancer," enrolled 6 participants. The trial investigated the combination of pembrolizumab and ramucirumab in patients with Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, and Stage IVB Lung Cancer AJCC v8.

Key results

For the outcome of "Overall Response Rate" in the "Treatment (Ramucirumab, Pembrolizumab)" group, the reported value was 0 percentage of participants.

Regarding safety, the "Number of Adverse Events" was reported multiple times for the "Treatment (Ramucirumab, Pembrolizumab)" group, with individual event counts of 4, 4, 3, 2, 3, 2, 1, 4, 1, 2, and 1.

What this means

The results from this Phase 2 trial indicate that the combination of pembrolizumab and ramucirumab did not demonstrate an objective response in the small cohort of patients with EGFR mutant recurrent or metastatic non-small cell lung cancer. The 0% overall response rate suggests that this specific combination may not be effective for this patient population under the study conditions. Safety data reported various numbers of adverse events.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04120454, titled "Ramucirumab and Pembrolizumab for the Treatment of EGFR Mutant Recurrent or Metastatic Non-small Cell Lung Cancer," were posted on 2025-07-11 on clinicaltrials.gov.