A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company; ImClone LLC
• Treatments: Antibodies, Monoclonal; Carboplatin; Cetuximab; Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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