NCT03126799

A Study of Tarceva vs. Avastin+Tarceva for Advanced NSCLC With EGFR m(+)

A Randomized Phase II Study of Erlotinib Alone Versus Erlotinib Plus Bevacizumab for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutations

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab is significantly necessary for developing new standard treatment in first-line therapy in Korean EGFR mutant NSCLC patients. In this study, The investigators will investigate the efficacy and safety of Erlotinib and Bevacizumab combination compare to Erlotinib alone in Korean EGFR-mutant NSCLC patients.

Detailed description

EGFR-TKIs are the standard first-line treatment option for EGFR-mutant NSCLC. After a randomized phase II trial, JO25567 was presented at 2014 ASCO, the synergistic effect of progression-free survival(PFS) could be expected when EGFR TKI, Erlotinib is combined with Antiangiogenesis agent, Bevacizumab. Even Korean and Japanese are classified as Asian based on location, the figure of Korean is more tended to Western people due to the dietary life in recent years. However the incidence rate of EGFR mutation positive patients in Korea is much higher than Western countries. Therefore Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab is significantly necessary for developing new standard treatment in first-line therapy in Korean EGFR mutant NSCLC patients. In this study, The investigators will investigate the efficacy and safety of Erlotinib and Bevacizumab combination compare to Erlotinib alone in Korean EGFR-mutant NSCLC patients.

Conditions

• EGFR Positive Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Erlotinib plus Bevacizumab	Erlotinib 150mg, po, daily, q 3weeks plus Bevacizumab 15mg/kg, IV, on D1 Q 3 weeks
DRUG	Erlotinib	Erlotinib 150mg, po, daily, Q weeks

Timeline

• Start date: 2016-11-01
• Primary completion: 2021-12-31
• Completion: 2023-07-20
• First posted: 2017-04-24
• Last updated: 2022-04-06

Locations

1 site across 1 country: South Korea