A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0001111
- Lead Sponsor
- Eli Lilly Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5
Key Inclusion Criteria
- Histologically or cytologically confirmed squamous Non-Small Cell Lung Cancer
- Stage IV disease at time of study entry based on American Joint Committee on Cancer 7th edition
- Measurable disease at time of study entry as defined by RECIST(Response Evaluation Criteria in Solid Tumors)1.1
Key Exclusion Criteria
- Nonsquamous Non-Small Cell Lung Cancer
- 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 study enrollment
- 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 best objective response rates
- Secondary Outcome Measures
Name Time Method Overall Survival, etc.