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R. Dalal
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-091 - Multicenter, Randomized, Double-Blind Study of Erlotinib plus Ramucirumab or Placebo in Patients with EGFR Mutation-Positive Metastatic NSCLC (ID 1560)
09:30 - 09:30 | Author(s): R. Dalal
- Abstract
Background:
Ramucirumab, a human IgG1 monoclonal antibody, binds to Vascular Endothelial Growth Factor (VEGF) Receptor 2, preventing binding of VEGF-A, C and D. Ramucirumab in combination with docetaxel has demonstrated improvement in overall survival, progression free survival (PFS), objective response rate and disease control rate in 2nd line treatment of NSCLC patients in the phase III REVEL study, which included non-squamous and squamous cell carcinoma patients. Although erlotinib is recognized as one of the standard of care options in the frontline treatment of patients whose tumors harbor an Epidermal Growth Factor Receptor (EGFR) mutation, it is hypothesized that the duration of disease control would be greater when an antiangiogenic agent such as ramucirumab is added to erlotinib. This global phase Ib/III trial will assess safety, tolerability and efficacy (phase III) of the combination of ramucirumab with erlotinib in previously untreated stage IV NSCLC patients harboring activating EGFR mutations. The trial is planned to be conducted in ~120 sites in the Americas, Europe, and Asia and is currently open for enrollment. (RELAY, NCT02411448)
Methods:
In part A (phase Ib) approximately 12 patients (6 Japan + 6 US/EU) will receive ramucirumab (10mg/kg on day 1) every two weeks + erlotinib (150 mg/day). DLT assessment will be performed after patients complete four weeks of treatment. In part B (phase III), approximately 450 patients will be randomized in a 1:1 ratio to receive ramucirumab or placebo every two weeks with erlotinib until disease progression, unacceptable toxicity, or other withdrawal criteria are met. The primary endpoint is PFS. There are 3 planned interim analyses that will evaluate safety, futility and efficacy, respectively. Other secondary endpoints include overall survival, objective response rate, disease control rate, duration of response, safety and quality of life.
Results:
Not applicable
Conclusion:
Not applicable
