Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Summary

The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.

Timeline

Start

2019-07-25

Primary completion

2026-12

Completion

2027-01

Publications

• Le X, Patel JD, Shum E, Baik C, Sanborn RE, Shu CA, Kim C, Fidler MJ, Hall R, Elamin YY, Tu J, Blumenschein G, Zhang J, Gibbons D, Gay C, Mohindra NA, Chae Y, Boumber Y, Sabari J, Santana-Davila R, Rogosin S, Herzberg B, Creelan B, Pellini B, Tanvetyanon T, Heeke S, Hernandez M, Gray JE, Saltos A, Heymach JV. A Multicenter Open-Label Randomized Phase II Study of Osimertinib With and Without Ramucirumab in Tyrosine Kinase Inhibitor-Naive EGFR-Mutant Metastatic Non-Small Cell Lung Cancer (RAMOSE trial). J Clin Oncol. 2025 Feb;43(4):403-411. doi: 10.1200/JCO.24.00533. Epub 2024 Oct 8.

Drugs

Indications