A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before
Completed · Phase 2
Conditions studied: Non-Small Cell Lung Cancer
In brief
The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.
Key facts
- Study ID
- NCT00870870
- Run by
- Eli Lilly and Company
- People needed
- 64
- Starts
- 2009-03-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2018-06-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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
You may not qualify if…
- Has uncontrolled brain metastases
- Has leptomeningeal disease
- Has received previous chemotherapy for NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
- 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
Where it is running
- ImClone Investigational Site — Anniston, Alabama, United States
- ImClone Investigational Site — La Jolla, California, United States
- ImClone Investigational Site — Orange, California, United States
- ImClone Investigational Site — Orlando, Florida, United States
- ImClone Investigational Site — Atlanta, Georgia, United States
- ImClone Investigational Site — Chicago, Illinois, United States
- ImClone Investigational Site — Chicago, Illinois, United States
- ImClone Investigational Site — Albuquerque, New Mexico, United States
- ImClone Investigational Site — New York, New York, United States
- ImClone Investigational Site — New York, New York, United States
- ImClone Investigational Site — New York, New York, United States
- ImClone Investigational Site — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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