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OpenTrials
Completed

NCT Number: NCT00063388

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

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

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Key information

Conditions

Non-Small-Cell Lung Cancer Brain Damage, Chronic Brain Diseases Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Diseases Cerebral Palsy Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ImClone Investigational Site, Aventura, Florida, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Cetuximab

Biological

Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).

Other names: Erbitux

Primary outcomes

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

    Time frame: Every 8 weeks

Secondary outcomes

  1. Determine the tumor response rate in the total population and in EGFR- subjects

    Time frame: Every 8 weeks

  2. Time to disease progression in the EGFR+ and total populations.

    Time frame: Every 8 weeks

  3. Survival in the EGFR+ and total populations.

    Time frame: Every 8 weeks

  4. Safety in the EGFR+ and total populations.

    Time frame: Every 8 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jun 27, 2003
Registry last updated
Apr 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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