A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0001107
- Lead Sponsor
- Eli Lilly Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 15
Key Inclusion Criteria
- Histologically or cytologically confirmed squamous NSCLC
- Stage IV disease at time of study entry based on AJCC 7th edition
- Measurable disease at time of study entry as defined by RECIST 1.1
- Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue
block) available for analysis of EGFR protein expression by IHC and other biomarker assessments
Key Exclusion Criteria
- Nonsquamous NSCLC
- Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies
targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
- Previous chemotherapy for NSCLC
- Major surgery or received any investigational therapy in the 4 weeks prior to randomization
- Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions,
which is allowed)
- Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants
(patients who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic
and no longer require treatment with steroids or anticonvulsants, are eligible)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Response Rate
- Secondary Outcome Measures
Name Time Method Overall Survival etc