Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Dec 24, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Drug: Paclitaxel (Taxane); Drug: Docetaxel (Taxane); Drug: Carboplatin; Drug: Cetuximab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Local InstitutionBirmingham, Alabama
- Local InstitutionMobile, Alabama
- Local InstitutionAnchorage, Alaska
- Local InstitutionTucson, Arizona
- Local InstitutionSpringdale, Arkansas
- Local InstitutionAnaheim, California
- Local InstitutionBakersfield, California
- Local InstitutionConcord, California
- Local InstitutionFountain Valley, California
- Local InstitutionGilroy, California
- Local InstitutionLong Beach, California
- Local InstitutionLos Angeles, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 24, 2015. Always confirm current availability with the study team.