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

Sponsor
National Cancer Center, Korea
Study ID
NCT03126799
Phase
PHASE2
Status
Unknown

Conditions

  • EGFR Positive Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Apr 24, 2017
Start date
Nov 1, 2016
Status verified
Apr 2022
Primary completion
Dec 31, 2021
Completion
Jul 20, 2023

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A: Erlotinib only
    Standard therapy arm: Erlotinib 150mg. po, qd, daily, q 3weeks
  • Experimental: B: Erlotinib plus Bevacizumab
    Study treatment arm; Erlotinib 150mg, po. qd, daily, q 3weeks plus Bevacizumab 15mg/kg, iv, on D1, q 3weeks.

Primary Outcome Measure

PFS [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to at least 36 months. ]

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