Know Cancer

forgot password

A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)

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

Thank you

Trial Information

A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)

To determine the tumor response rate and time to disease progression, survival and safety in
the EGFR-positive, EGFR-negative and total populations.

Inclusion Criteria

Inclusion Criteria

1. Subjects with recurrent or progressive NSCLC with either present or prior histologic
confirmation or pathologic confirmation of NSCLC

2. Subjects receiving 1 or more prior chemotherapy regimens for the treatment of
recurrent/metastatic disease, including at least 1 platinum-based combination

3. Unidimensionally measurable NSCLC

4. Subjects with tumor tissue available for EGFR assessment

5. ECOG performance status of 0 or 1

6. Subjects with asymptomatic brain metastasis were eligible; however, they must have
completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have
been off steroids

Exclusion Criteria

1. Women of childbearing potential who were 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. Male subjects must also have agreed to use effective contraception

2. Women of childbearing potential using a prohibited contraceptive method

3. Women who were pregnant or breastfeeding

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

Type of Study:


Study Design:

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

Outcome Measure:

The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects.

Outcome Time Frame:

Every 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:

May 2003

Completion Date:

June 2005

Related Keywords:

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



ImClone Investigational Site Indianapolis, Indiana  46202
ImClone Investigational Site St. Charles, Missouri  63301
ImClone Investigational Site Jacksonville, Florida  32207
ImClone Investigational Site Decatur, Illinois  62526
ImClone Investigational Site Boston, Massachusetts  02135