Carboplatin Plus Cetuximab for Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Carboplatin; Biological: Cetuximab

• Registration Number: NCT00097214
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This is a phase II study in previously untreated subjects with histologically or cytologically proven stage IIIB/IV NSCLC designed to determine the efficacy of first line treatment with carboplatin and cetuximab.

Detailed Description

Lung cancer is the second most common cancer diagnosed for both genders in the United States. Approximately 173,770 new cases are estimated for 2004. It is the leading cause of cancer deaths in both men and women, with approximately 160,440 deaths estimated for 2004. Prognosis for many is poor if not diagnosed at an early stage, and therapy for advanced disease is limited. The study will test carboplatin in combination with a newly approved drug called cetuximab, which is continuing to be tested in colorectal cancer and other cancers. Cetuximab is a monoclonal antibody, which is believed to work by attaching to an epidermal growth factor receptor (EGFR) on tumor cells and thereby blocking tumor cells from reproducing. It is an antibody to the EGFR. Fifty percent of lung cancers overexpress EGFR.

Rationale:

The present study is built upon the data from the described studies, incorporating cetuximab into a regimen of single-agent carboplatin. Previous data suggest that single agent carboplatin is active in NSCLC. The addition of biologic therapy with the anti-EGFR agent cetuximab to carboplatin will presumably maximize the therapeutic index while keeping toxicity to a minimum in patients with Stage IIIB/IV NSCLC.

Research Hypothesis:

The population being studied in this trial is subjects with previously untreated Stage IIIB or IV NSCLC. The research hypothesis is that these subjects will achieve a response (based on RECIST criteria) to therapy with the combination of carboplatin and cetuximab.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2004-11-18
• Study First Submitted QC: 2004-11-18
• Study First Posted: 2004-11-19
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-08
• Last Update Posted: 2010-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Carboplatin	Cetuximab 400 mg/m2 IV on Day 1, followed by weekly doses of 250 mg/m2 IV beginning on Day 8. Carboplatin AUC= 6 IV will be given on the first day of each 3-week cycle, beginning on Day 8. Therapy will continue for four cycles (12 weeks)for combination therapy
1	Cetuximab	Cetuximab 400 mg/m2 IV on Day 1, followed by weekly doses of 250 mg/m2 IV beginning on Day 8. Carboplatin AUC= 6 IV will be given on the first day of each 3-week cycle, beginning on Day 8. Therapy will continue for four cycles (12 weeks)for combination therapy

Primary Outcome Measures

Name	Time	Method
To evaluate the overall response rate	Every six months

Secondary Outcome Measures

Name	Time	Method
To evaluate the proportion of subjects with progression free survival (median and 6 months)	Every six months
To evaluate survival times (median and 1-year)	Every six months
To evaluate the toxicity profiles of the treatment regimen	Every 12 weeks
To evaluate symptom response rate using the Lung Cancer Subscale (LCS) of the FACT-L	Every 12 weeks

Trial Locations

Locations (1)

ImClone Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States