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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: ImClone LLC
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cetuximab; Docetaxel; Paclitaxel; Taxane

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.