Lung Cancer Clinical Trial

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

Summary

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

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Full Description

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).

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Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

64

Study ID:

NCT00870870

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 12 Locations for this study

See Locations Near You

ImClone Investigational Site
Anniston Alabama, 36207, United States
ImClone Investigational Site
La Jolla California, 92093, United States
ImClone Investigational Site
Orange California, 92868, United States
ImClone Investigational Site
Orlando Florida, 32806, United States
ImClone Investigational Site
Atlanta Georgia, 30341, United States
ImClone Investigational Site
Chicago Illinois, 60612, United States
ImClone Investigational Site
Chicago Illinois, 60637, United States
ImClone Investigational Site
Albuquerque New Mexico, 87131, United States
ImClone Investigational Site
New York New York, 10011, United States
ImClone Investigational Site
New York New York, 10021, United States
ImClone Investigational Site
New York New York, 10032, United States
ImClone Investigational Site
Cincinnati Ohio, 45247, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

64

Study ID:

NCT00870870

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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