A Study in Non-Small Cell Lung Cancer
- Conditions
- advanced nonsquamous non-small cell lung carcinomaMedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-024014-60-DE
- Lead Sponsor
- Eli Lilly and Company Limited, Indianapolis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 156
Patients will be at least 18 years of age with histologically or cytologically confirmed Stage IV (AJCC edition 7) nonsquamous non-small cell lung carcinoma. 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 Eastern Cooperative Oncology Group status of 0 or 1as well as adequate hematologic, coagulation, and organ function. Patients must have fasting serum glucose <125mg/dL (6.9 mmol/L), and hemoglobin A1C =6%.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 94
Patients must not have an uncontrolled intercurrent illness, leptomeningeal disease, or active infection requiring parenteral therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method