New Protocol: Osimertinib with Ramucirumab for EGFR-Mutated NSCLC

Randomized, open-label, multicenter, phase 2 study [RAMOSE trial]

First-line metastatic EGFR-mutant NSCLC

Osimertinib + Ramucirumab (n = 93) vs. Osimertinib alone (n = 46) until progression

mPFS: 24.8 mos vs. 15.6 mos (osimertinib + ramucirumab vs. osimertinib) (HR: 0.55 [0.32-0.93])

1-year PFS: 77% vs. 62%

2-year PFS: 51% vs. 30%

ORR: 76.3% vs. 80.4%

DCR: 96.8% vs. 95.7%

Grade ≥3 AE: 53% vs. 41%

Common AEs: Diarrhea, fatigue, headache, cough (osimertinib + ramucirumab); Diarrhea, fatigue, rash (osimertinib)

Hypertension: 23% vs. 2%

Proteinuria: 19% vs. 2%

No Grade 5 AEs; one Grade 4 AE (hyponatremia)

Le X,Patel JD,Shum E A Multicenter Open-Label Randomized Phase II Study of Osimertinib With and Without Ramucirumab in Tyrosine Kinase Inhibitor–Naïve EGFR-Mutant Metastatic Non–Small Cell Lung Cancer (RAMOSE trial)

Reviewed by Ulas D. Bayraktar, MD on Mar 2, 2025