Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Condition: Non-Small-Cell Lung Carcinoma
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Paclitaxel (Taxane); Docetaxel (Taxane); Carboplatin; Cetuximab
Intervention description: IV, 225 mg/m^2; IV, 75 mg/m^2; AUC=6, q 3 weeks (6 cycles maximum); Intravenous, 400 mg/m^2, initial dose followed by 250 mg/m^2, weekly starting on Week 2
Intervention MeSH terms: Paclitaxel; Docetaxel; Carboplatin; Cetuximab; Taxane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 755.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer

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.
    

Eligibility 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.