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)
Phase 1
- Conditions
- ung Cancer
- Registration Number
- JPRN-jRCTs051180183
- Lead Sponsor
- Teraoka Shunsuke
- Brief Summary
Compared with Osi, Osi + Bv failed to show prolongation of PFS in advanced lung adenocarcinoma patients with EGFR T790M mutation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
1. 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
Exclusion Criteria
1. Subjects with interstitial lung disease
2. Subjects with high risk of bleeding
3. Positive test for hepatitis B virus antigen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: safety<br>Phase II: progression-free survival
- Secondary Outcome Measures
Name Time Method Overall response rate, time to treatment failure, survival time