CompletedPhase 3NCT00112294

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

StatusCompleted
PhasePhase 3
U.S. locations124
SponsorEli Lilly and Company
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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