An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Cisplatin and Pemetrexed With or Without Cixutumumab as First Line Therapy in Patients with Advanced Nonsquamous Non Small Cell Lung Carcinoma
Phase 2
Completed
- Conditions
- Lung cancer10027656
- Registration Number
- NL-OMON38158
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Patients will be at least 18 years old with histologically or cytologically confirmed Stage IV (AJCC edition 7) nonsquamous NSCLC. Patients may have either measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v. 1.1), and must have ECOG status of 0 or 1 as well as adequate hematologic, coagulation, and organ function. Patients must have fasting serum glucose < 125 mg/dL (6.9 mmol/L), and hemoglobin A1C <= 6%.
Exclusion Criteria
Patients must not have an uncontrolled intercurrent illness, leptomeningeal disease, or active infection requiring parenteral therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method