NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051180183

Registered date:26/03/2019

A phase I study of osimertinib with bevacizumab and randomized phase II study of osimertinib with or without bevacizumab in EGFR mutated, T790M positive patients who had progressed EGFR-TKIs. (WJOG8715L)

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedLung Cancer
Date of first enrollment10/02/2017
Target sample size86
Countries of recruitment
Study typeInterventional
Intervention(s)Arm A: Osimertinib 80mg/day, orally every day until disease progression Arm A: Osimertinib 80mg/day, orally every day until disease progression plus bevacizumab 15mg/kg, intravenously every 3 weeks, until disease progression

Outcome(s)

Primary OutcomePhase I: safety Phase II: progression-free survival
Secondary OutcomeOverall response rate, time to treatment failure, survival time

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. Pathologically proven, advanced lung adenocarcinoma 2. Harbor with EGFR mutation 3. Radiological progression was confirmed after 1st/2nd EGFR-TKI, and T790M was confirmed. 4. With evaluable lesion per RECIST ver 1.1 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Exclude criteria1. Subjects with interstitial lung disease 2. Subjects with high risk of bleeding 3. Positive test for hepatitis B virus antigen

Related Information

Contact

Public contact
Name Shunsuke Teraoka
Address 811-1, kimiidera, wakayama city Wakayama Japan 6418509
Telephone +81-734410619
E-mail teraoka@wakayama-med.ac.jp
Affiliation Wakayama medical university hospital
Scientific contact
Name Shunsuke Teraoka
Address 811-1, kimiidera, wakayama city Wakayama Japan 6418509
Telephone +81-734410619
E-mail teraoka@wakayama-med.ac.jp
Affiliation Wakayama medical university hospital