A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before
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Keep this study
Lead
Eli Lilly and Company
Participants with Stage IIIb or IV non-small cell lung cancer (NSCLC) who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus \[vs.\] nonsquamous).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has histologically or cytologically confirmed, Stage IIIb - IV NSCLC
Has metastatic disease
Has a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST)
Has adequate hematologic function
Has adequate hepatic function
Has adequate renal function
Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Receiving any other investigational agent(s)
Has a history of treatment with other agents targeting the insulin-like growth factor (IGF) or the epidermal growth factor (EGF) receptor
Has a known allergy / history of hypersensitivity reaction to any of the treatment components
Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range \[fasting glucose \<160 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN) and hemoglobin A1C≤ 7%\] and that they are on a stable dietary or therapeutic regimen for this condition
Has an uncontrolled intercurrent illness
Pregnant or lactating
Has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years
Has superior vena cava syndrome contraindicating hydration
Has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure
Has any National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version (v) 3.0 Grade ≥2 peripheral neuropathy
Has significant third space fluid retention, requiring repeated drainage
You may not be if
Has uncontrolled brain metastases
Has leptomeningeal disease
Clareo Health | A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before
