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A Randomized Multicenter Phase III Study of Taxane/Carboplatin/Cetuximab Versus Taxane/Carboplatin as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Phase 3
18 Years
Not Enrolling
Non-Small-Cell Lung Carcinoma

Thank you

Trial Information

A Randomized Multicenter Phase III Study of Taxane/Carboplatin/Cetuximab Versus Taxane/Carboplatin as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

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

- 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

- 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

- Altered mental status or psychiatric condition that prohibits understanding or
rendering of consent.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median Number of Months of Progression-free Survival (PFS)

Outcome Description:

Interval between randomization date & earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): >=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments & were still alive, date of randomization used.

Outcome Time Frame:

From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

August 2008

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Non-Small Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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