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Phase Ib/IIa Study of an Anti-Epidermal Growth Factor Receptor (EGFr) Antibody Cetuximab in Combination With Carboplatin-Paclitaxel in Patients With Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

Phase Ib/IIa Study of an Anti-Epidermal Growth Factor Receptor (EGFr) Antibody Cetuximab in Combination With Carboplatin-Paclitaxel in Patients With Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer

The study will enroll approximately 33 chemotherapy-naive stage IV non-small cell lung
cancer patients. Patients will receive 3-week cycles of therapy with the exception of the
initial cycle where the patients will receive 4 cycles of therapy. Patients will be
enrolled after EGFr expression is confirmed and the study inclusion and exclusion criteria
are met. An initial dose of cetuximab will be administered prior to the initiation of
chemotherapy. Thereafter, cetuximab will be infused weekly. On the first day of each
cycle, a paclitaxel infusion will be administered post completion of the cetuximab infusion,
immediately followed by a carboplatin infusion. Patients will receive cetuximab in
combination with carboplatin and paclitaxel for two cycles or until disease progression or
until the patient exhibits intolerable toxicities. Patients will be evaluated for a tumor
response at the end of every two cycles of therapy and evaluated for safety throughout the

Inclusion Criteria:

The following inclusion criteria must be met:

- The patient has stage IV NSCLC with either present or prior histologic or pathologic
confirmation of NSCLC

- The patient has uni-dimensionally measurable stage IV NSCLC

- The patient has chemotherapy-naive stage IV NSCLC. The patient may have recurrent
disease if prior radiation therapy was received. Pathological confirmation of
recurrence is required for disease within a radiation portal.

- The patient's ECOG performance status is ≤ 2 at study entry.

- The patient has immunohistochemical evidence of EGFr expression (≥1+). Patients who
do not have tumor tissue available for EGFr testing will undergo a biopsy of an
accessible tumor. EGFr expression must be confirmed prior to study entry.

- The patient has given signed informed consent.

- The patient is 18 years of age or older.

- The patient has adequate hematologic function, as defined by an absolute neutrophil
(ANC)≥ 1,500/mL3 , a WBC count≥3,000/mL3, a platelet count ≥100,000/mL3, and a
hemoglobin level ≥9g/dL.

- The patient has adequate hepatic function as defined by a total bilirubin level ≤1.5
X the upper limit of normal (ULN) and an alkaline phosphatase, AST, and ALT level
≤2.5 X the ULN.

- The patient has adequate renal function with a serum creatinine level ≤1.5 mg/dL or a
creatinine clearance ≥60 cc/minute.

- The patient is disease free from a previously treated malignancy, other than the
disease under study, for greater than 3 years (patients with a history of a previous
basal cell carcinoma of the skin or preinvasive carcinoma of the cervix will not be

- The patient, if a woman, agrees to use effective contraception if childbearing
potential exists. The patient, if a man, agrees to use effective contraception.

Exclusion Criteria:

The following ten exclusion criteria are for this study:

- The patient has received prior cetuximab therapy.

- The patient has disease amenable to curative surgery.

- The patient has received prior chemotherapy for the disease under study.

- The patient has received wide field radiation therapy within 4 weeks prior to the
first infusion of cetuximab. The patient may have local irradiation for the
management of tumor-related symptoms.

- The patient has undergone major thoracic or abdominal surgery within 30 days (to
allow for a full recovery)prior to the first infusion of cetuximab.

- The patient has a history of uncontrolled angina,arrhythmias, or congestive heart

- The patient has uncontrolled seizure disorder, active neurological disease (not tumor
related), or grade ≥2 neuropathy (patients with meningeal or central nervous system
[CNS] involvement by the tumor will be eligible).

- The patient has a history of hypersensitivity to Cremophor EL.

- The patient, if a woman, is pregnant (confirmed by serum BHCG) or breastfeeding.

- The patient has received any investigation agents within 30 days of study entry.

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:

Assess the safety profile of cetuximab when used in combination with paclitaxel and carboplatin

Outcome Time Frame:

8 Weeks

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:

December 2000

Completion Date:

May 2003

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • cetuximab
  • epidermal growth factor receptor
  • antibody
  • non-small cell lung cancer
  • carboplatin
  • paclitaxel
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



ImClone Investigational Site Denver, Colorado  80262
ImClone Investigational Site Greenwich, Connecticut  06830
ImClone Investigational Site Indianapolis, Indiana  46202