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Trial Summary
| Protocol No. | CTO-LUN18-335 | ||
|---|---|---|---|
| Status | CLOSED TO ACCRUAL | ||
| Principal Investigator | Hanna, Nasser | ||
| Scope | Local | ||
| Phase | Phase II | ||
| Age Group | Adult | ||
| Title | An Open-Label Randomized Phase II Study of Combining Osimertinib with and without Ramucirumab in TKI-naïve EGFR-mutant Locally Advanced or Metastatic NSCLC | ||
| Description | 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. | ||
| Key Eligibility | In order to be eligible to take part in this trial, patients must meet the following criteria:
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| Applicable Disease Sites | Lung | ||
| Participating Institutions | Indiana University (IU) | ||
| Treatment Type | Treatment | ||
| Contact | Phone: (317) 278-5632 Email: iutrials@iu.edu | ||