A Phase II Trial of Carboplatin Plus Cetuximab for the Treatment of Stage IIIb/IV Non-Small Cell Lung Cancer

Inclusion Criteria

INCLUSION CRITERIA:

To be eligible for the study, subjects must fulfill all of the following criteria.

- Subjects must have signed an approved informed consent.

- Subjects with histologically or cytologically documented stage IIIB (supraclavicular
lymph node, high neck node, or pleural effusion involvement) or IV NSCLC. Disease
must be newly diagnosed or recurrent at least 1 year post adjuvant therapy.

- Subjects with measurable disease.

- Subjects with ECOG performance status 0-1.

- If diagnostic tissue or slides are available for a subject, these must be submitted
for testing of EGFR status.

- Subjects with asymptomatic brain metastasis are eligible; however, they must have
completed radiotherapy/radiosurgery at least 2 weeks prior to enrollment.
Radiotherapy must have been completed >2 weeks prior to enrollment and the subject
must have recovered from all adverse effects of prior radiotherapy. No previous
irradiation to the only area of measurable disease. New lesions that developed in a
previously irradiated area will be allowed.

- Subjects ≥18 years of age.

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 4 weeks after the
study in such a manner that the risk of pregnancy is minimized. WOCBP include any
female who has experienced menarche and who has not undergone successful surgical
sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or
is not postmenopausal [defined as amenorrhea ≥12 consecutive months; or women on
hormone replacement therapy (HRT) with documented serum follicle stimulating hormone
(FSH) level >35mIU/mL]. Even women who are using oral, implanted or injectable
contraceptive hormones or mechanical products such as an intrauterine device or
barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing
abstinence or where partner is sterile (e.g., vasectomy), should be considered to be
of child bearing potential. WOCBP must have a negative serum or urine pregnancy test
(minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the
start of study medication.

Physical and Laboratory Test Findings

- Subjects with adequate hematologic function defined as: ANC ≥1,500/mm 3 ; WBC

≥3,000/mm 3 ; platelets ≥100,000/mm 3 ; and hemoglobin ≥9 g/dL.

- Subjects with adequate hepatic function defined as: total bilirubin ≤1.5 x upper
limit of normal (ULN) or AST ≤2.5 x ULN.

- Subjects with adequate renal function defined as a serum creatinine level ≤1.5 mg/dL
or a creatinine clearance ≥60 cc/minute.

EXCLUSION CRITERIA:

Any of the following criteria will make the subject ineligible to participate in this
study:

- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period and for up to 4 weeks after the study. Subjects who are men
must also agree to use effective contraception.

- WOCBP using a prohibited contraceptive method.

- Women who are pregnant or breastfeeding

- Women with a positive pregnancy test on enrollment or prior to study drug
administration.

- Subjects who have had prior malignancy, except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
subject has been disease-free for 5 years.

- Subjects with significant history of cardiac disease, i.e., uncontrolled
hypertension, unstable angina, uncontrolled congestive heart failure, cardiomyopathy
with decreased ejection fraction, myocardial infarction within the past year, or
cardiac ventricular arrythmias requiring medication.

- Subjects with an uncontrolled seizure disorder, or active neurological disease.

- Subjects with symptomatic brain metastasis.

Prohibited Therapies and/or Medications

- Subjects who have received prior systemic chemotherapy. Subjects with no more than
one prior adjuvant regimen for initially diagnosed disease are eligible for the
study.

- Subjects with a history of prior cetuximab or other therapy that specifically and
directly targets the EGFR pathway.

- Subject with prior severe reaction to a monoclonal antibody.

- Subjects with prior erythropoietin (i.e., Epogen, Procrit) treatment

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled into this study.