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

Complete Title: An Open-Label Randomized Phase II Study of Combining Osimertinib with and without Ramucirumab in TKI-naive EGFR-mutant Locally Advanced or Metastatic NSCLC
Trial Phase: II
Investigator: Christina Baik

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.

Keywords:
  • Lung Carcinoma, Non-Small-Cell (NSCLC)
  • Metastatic Solid Tumors
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Adult
II
Christina Baik
RG1006640
NCT03909334
An Open-Label Randomized Phase II Study of Combining Osimertinib with and without Ramucirumab in TKI-naive EGFR-mutant Locally Advanced or Metastatic NSCLC
Lung Carcinoma, Non-Small-Cell (NSCLC)
Metastatic Solid Tumors