Phase II Study in Patients With Recurrent Non-Small-Cell Lung Cancer

Completed · Phase 2

Conditions studied: Non-Small-Cell Lung Cancer

In brief

Determine tumor response rate and time to disease progression, survival and safety in total populations.

Key facts

Study ID

NCT00063388

Run by

Eli Lilly and Company

People needed

66

Starts

2003-05-01

Expected to finish

2005-06-01

Last updated by the study team

2010-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
• Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
• Unidimensionally measurable NSCLC
• Subjects with tumor tissue available for EGFR assessment
• ECOG performance status of 0 or 1
• 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

You may not qualify if…

• 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
• Women of childbearing potential using a prohibited contraceptive method
• Women who were pregnant or breastfeeding
• Women with a positive pregnancy test on enrollment or prior to study drug administration.

Where it is running

• ImClone Investigational Site — Aventura, Florida, United States
• ImClone Investigational Site — Miami Beach, Florida, United States
• ImClone Investigational Site — Chicago, Illinois, United States
• ImClone Investigational Site — Indianapolis, Indiana, United States
• ImClone Investigational Site — South Bend, Indiana, United States
• ImClone Investigational Site — Boston, Massachusetts, United States
• ImClone Investigational Site — Boston, Massachusetts, United States
• ImClone Investigational Site — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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