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A Clinical Trial of the Safety and Efficacy of ABX-EGF as Second Line Treatment for Advanced Non-Small Lung Cancer

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

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Trial Information

A Clinical Trial of the Safety and Efficacy of ABX-EGF as Second Line Treatment for Advanced Non-Small Lung Cancer

Inclusion Criteria:

- 18 years of age or older.

- Diagnosis of NSCLC.

- Unidimensionally measurable disease.

- Documented disease progression within 6 months of the subject's last dose of
carboplatin and paclitaxel in treatment arm 1, part 2 of Immunex Protocol 054.0004
(Amgen Protocol 20025404).

- Disease stage IIIB with pericardial or pleural effusion, or stage IV.

- Life expectancy of at least 12 weeks.

- ANC greater than or equal to 1.5 x 10^9/L, platelet count greater than or equal to
100 x 10^9/L.

- Adequate hematology function

- Adequate renal function

- Adequate hepatic function

- ECOG score of less than 2.

- Brain metastases, if present, must be controlled and asymptomatic.

Exclusion Criteria:

- Calcium >ULN (treatment for hypercalcemia allowed).

- Use of any investigational therapy within 30 days of ABX-EGF infusion.

- Any cancer therapy for NSCLC other than paclitaxel and carboplatin per Immunex
Protocol 054.0004 (Amgen Protocol 20025404), such as radiation therapy, surgery, or

- Paclitaxel or carboplatin within 30 days before the first ABX-EGF infusion.

- Radiation therapy within 2 weeks before ABX-EGF infusion.

- LVEF less than 45% as measured by MUGA.

- Symptomatic ventricular arrhythmia or symptomatic conduction abnormality.

- Myocardial infarction within 1 year before first dose of study drug.

- History of cancer that has required treatment or been active within past 5 years,
other than NSCLC, basal cell carcinoma, or cervical carcinoma in situ.

- Women (e.g., of childbearing potential, who are post-menopausal for less than six
months, not surgically sterilized or not abstinent) who are not willing to use an
oral or implanted contraceptive, double barrier birth control, or an IUD during the
course of the study and for 6 months following treatment.

- Men not willing to use contraception upon enrollment into this study and for 1 month
following treatment.

- Women who are breast-feeding or have a positive pregnancy test within 72 hours of
first study drug administration.

- Known to be HIV positive.

- Any patient who's best medical interests would not be met by entry in the study in
the opinion of the Investigators.

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:

Objective Tumor Response

Outcome Time Frame:

End of initial 6 week treatment period

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2003

Completion Date:

December 2004

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Neoplasm Metastasis
  • Lung Cancer
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis