A clinical trial intended to assess the Efficacy and Safety of MYL-1402O Compared With Avastin®, in the First-line Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer
Phase 3
Completed
- Conditions
- Health Condition 1: null- Non-Squamous Non-Small Cell Lung Cancer
- Registration Number
- CTRI/2016/12/007557
- Lead Sponsor
- Mylan GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 191
Inclusion Criteria
1.Has demonstrated the ability to understand verbal and/or written instructions, to provide written informed consent, and is capable and agreeable to comply with protocol requirements.
2.Male or female at least 18 years of age at the time of signing an informed consent form (ICF).
3.Has a documented imaging diagnosis of Stage IV unresectable, recurrent or metastatic nsNSCLC.
4.Has measurable disease with at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
5.Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
6.Has at least 6 months of expected survival.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the ORR of MYL-1402O compared with Avastin in combination with a carboplatin and paclitaxel (CP) chemotherapy treatment of unresectable, recurrent or metastatic Stage IV nsNSCLCTimepoint: At 18 weeks
- Secondary Outcome Measures
Name Time Method â??To assess the safety profile of MYL-1402O <br/ ><br>â??To assess Disease Control Rate at 18 weeks, CR, PR or SD <br/ ><br>â??To assess time-to-event endpoints: median PFS and OS <br/ ><br>â??To assess the potential immunogenicity (detection of anitbodies to bevacizumab) <br/ ><br>â??To compare the PK profile using a population PK approach <br/ ><br>Timepoint: At 18 weeks and end of study