Clinical trial NCT00097214 (phase 2, status: completed)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboplatin
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility 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.