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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPaclitaxel (Taxane) and Docetaxel (Taxane)

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 24, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?124 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

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

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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).

Reasons someone may not be able to joinExclusion 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.

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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