A Randomized, Double-Blind, Phase 2 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy
- Conditions
- on-small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080221986
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Non-squamous Non-Small Cell Lung Cancer disease
Clinical stage IV or recurrent disease
One prior first-line platinum-based chemotherapy regimen with or without maintenance therapy
For Non-Small Cell Lung Cancer (NSCLC) tumors other than squamous cell histology, the epidermal growth factor receptor (EGFR) mutation status is known prior to randomization
For participants with activating epidermal growth factor receptor (EGFR) mutation ONLY, prior epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) monotherapy (only one regimen in the setting of single use) should be utilized
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version RECIST version 1.1
Adequate organ function
Estimated life expectancy of at least 3 months.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method