Bevacizumab and Erlotinib in Lung Cancer With Brain Metastases, a Phase II Trial

Sponsor
National Taiwan University Hospital
Study ID
NCT02655536
Phase
PHASE2
Status
Unknown

Conditions

  • Brain Neoplasms
  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
20 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab plus erlotinib — DRUG
    Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of every 3 weeks cycle by IV infusion erlotinib will be give at 150mg orally every day for 21 days of every 3 weeks cycle
  • Erlotinib — DRUG
    erlotinib will be give at 150mg orally every day for 21 days of every 3 weeks cycle

Study Details

This is an open-label, randomized, multicenter phase II study conducting in 3 medical centers in Asia. Patients will receive erlotinib in combination with bevacizumab or erlotinib alone. This study will enroll EGFR-mutant NSCLC patients who have asymptomatic brain metastases. The primary objective is to compare the systemic progression-free survival (PFS) to bevacizumab plus erlotinib versus erlotinib alone in patients with EGFR mutant NSCLC who have asymptomatic brain metastases.

Key Dates

First listed
Jan 14, 2016
Start date
Aug 1, 2017
Status verified
Jul 2018
Primary completion
Jun 30, 2019
Completion
Dec 31, 2019

Study Design

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

Arms

  • Experimental: bevacizumab plus erlotinib
    bevacizumab 15mg/kg every 3 weeks plus erlotinib 150mg per day
  • Active Comparator: erlotinib
    erlotinib 150mg per day

Primary Outcome Measure

Progression-free survival [ Time Frame: The PFS will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months. ]

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