Overview

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