Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Completed · Phase 3

Conditions studied: Non-Small-Cell Lung Carcinoma

In brief

The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.

Key facts

Study ID

NCT00112294

Run by

Eli Lilly and Company

People needed

755

Starts

2004-12-01

Expected to finish

2008-08-01

Last updated by the study team

2015-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
• Tumor/disease lesions that can be measured bidimensionally.
• Must be able to carry-out work of light or sedentary nature (e.g. light house work, office work).
• Adequate recovery from recent surgery or radiation therapy.
• Must be at least 4 weeks from last major surgery or prior treatment with an investigational agent. At least 12 weeks from any radiation therapy to chest.
• Accessible for treatment, follow-up and required visits at a participating center(s).

You may not qualify if…

• Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.
• Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted therapy.
• Prior severe infusion reaction to antibody therapy.
• Concurrent malignancy (previous malignancy without evidence of disease for 5 years will be allowed to enter trial).
• Concurrent chemotherapy or therapy with another investigational agent not indicated in the protocol.
• Serious uncontrolled medical disorders that would impair the ability to receive therapy.
• History of myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure.
• Symptomatic or uncontrolled metastases in the central nervous system. Subjects receiving a glucocorticoid for central nervous system (CNS) metastases are not eligible, but those receiving an anticonvulsant are eligible.
• Peripheral neuropathy >= grade 2 (Common Toxicity Criteria Adverse Event [CTCAE] Version 3.0).
• Inadequate hematologic and/or liver and/or kidney function.
• Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for entire trial and up to 4 weeks after the study.
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment prior to study drug administration.
• Altered mental status or psychiatric condition that prohibits understanding or rendering of consent.

Where it is running

• Local Institution — Mobile, Alabama, United States
• Local Institution — Anchorage, Alaska, United States
• Local Institution — Tucson, Arizona, United States
• Local Institution — Springdale, Arkansas, United States
• Local Institution — Anaheim, California, United States
• Local Institution — Bakersfield, California, United States
• Local Institution — Concord, California, United States
• Local Institution — Fountain Valley, California, United States
• Local Institution — Gilroy, California, United States
• Local Institution — Long Beach, California, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — Montebello, California, United States
• Local Institution — Oxnard, California, United States
• Local Institution — Rancho Mirage, California, United States
• Local Institution — San Diego, California, United States
• Local Institution — Stockton, California, United States
• Local Institution — Vista, California, United States
• Local Institution — Lakewood, Colorado, United States
• Local Institution — Binghamton, Connecticut, United States
• Local Institution — Hartford, Connecticut, United States
• Local Institution — New London, Connecticut, United States
• Local Institution — Norwich, Connecticut, United States
• Local Institution — Stamford, Connecticut, United States
• Local Institution — Waterbury, Connecticut, United States
• Local Institution — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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