A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (STELLA)
Phase 3
Not yet recruiting
- Conditions
- on-squamous Non-Small Cell Lung Cancer (NSCLC)Non-
- Registration Number
- TCTR20170929003
- Lead Sponsor
- mAbxience S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 650
Inclusion Criteria
- Males and female subjects aged 18Â years or above to less than or equal to 80 years
- Signed informed consent must be obtained before initiation of any study-specific procedures or treatment as confirmation of the subject’s awareness and willingness to comply with the study requirements.
- Subjects should have newly diagnosed or recurrent Stage IIIB/IV nonsquamous NSCLC (defined by seventh edition of the TNM classification for Lung Cancer, 2010) not amenable to curative intent surgery, and not have received any systemic therapy for advanced disease. For subjects with recurrent disease, at least 6 months must have elapsed from previous adjuvant treatment.
Exclusion Criteria
Inability to comply with protocol procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate measurment at week 18 18 months By RECIST Criteria
- Secondary Outcome Measures
Name Time Method Progress-free survial measurment at week 18 and week 52 18 and 52 weeks By RECIST Criteria