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Trial Summary


Protocol No.CTO-LUN18-335
StatusOPEN TO ACCRUAL
Principal InvestigatorHanna, Nasser
ScopeLocal
PhasePhase II
Age GroupAdult
TitleAn Open-Label Randomized Phase II Study of Combining Osimertinib with and without Ramucirumab in TKI-naÔve EGFR-mutant Locally Advanced or Metastatic NSCLC
DescriptionThe 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.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Histologically or cytologically confirmed non-squamous, non-small cell lung cancer
  • Locally advanced or metastatic disease, not amenable to curative surgery or radiotherapy.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesLung
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu