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

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer

Thank you

Trial Information

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

Lung cancer is the second most common cancer diagnosed for both genders in the United
States. Approximately 173,770 new cases are estimated for 2004. It is the leading cause of
cancer deaths in both men and women, with approximately 160,440 deaths estimated for 2004.
Prognosis for many is poor if not diagnosed at an early stage, and therapy for advanced
disease is limited. The study will test carboplatin in combination with a newly approved
drug called cetuximab, which is continuing to be tested in colorectal cancer and other
cancers. Cetuximab is a monoclonal antibody, which is believed to work by attaching to an
epidermal growth factor receptor (EGFR) on tumor cells and thereby blocking tumor cells from
reproducing. It is an antibody to the EGFR. Fifty percent of lung cancers overexpress EGFR.


The present study is built upon the data from the described studies, incorporating cetuximab
into a regimen of single-agent carboplatin. Previous data suggest that single agent
carboplatin is active in NSCLC. The addition of biologic therapy with the anti-EGFR agent
cetuximab to carboplatin will presumably maximize the therapeutic index while keeping
toxicity to a minimum in patients with Stage IIIB/IV NSCLC.

Research Hypothesis:

The population being studied in this trial is subjects with previously untreated Stage IIIB
or IV NSCLC. The research hypothesis is that these subjects will achieve a response (based
on RECIST criteria) to therapy with the combination of carboplatin and cetuximab.

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.


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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the overall response rate

Outcome Time Frame:

Every six months

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials@

Investigator Role:

Study Chair

Investigator Affiliation:

ImClone LLC


United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

April 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small
  • Lung
  • IIIB
  • IV
  • Carboplatin
  • Cetuximab
  • Stage IIIB non-small cell lung cancer
  • Stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



ImClone Investigational Site Atlanta, Georgia  30318
ImClone Investigational Site Decatur, Illinois  62526
ImClone Investigational Site Louisville, Kentucky  40202
ImClone Investigational Site Little Rock, Arkansas  72205
ImClone Investigational Site Winston-Salem, North Carolina  27103
ImClone Investigational Site Philadelphia, Pennsylvania  19107