Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

October 26, 2015 updated by: Eli Lilly and Company

A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Local Institution
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Local Institution
    • Ontario
      • Hamilton, Ontario, Canada
        • Local Institution
      • Montreal, Ontario, Canada
        • Local Institution
      • Toronto, Ontario, Canada
        • Local Institution
      • Windsor, Ontario, Canada
        • Local Institution
    • Quebec
      • Greenfield Park, Quebec, Canada
        • Local Institution
  • United States
    • Alabama
      • Mobile, Alabama, United States
        • Local Institution
    • Alaska
      • Anchorage, Alaska, United States
        • Local Institution
    • California
      • Bakersfield, California, United States
        • Local Institution
      • Corona, California, United States
        • Local Institution
      • Oxnard, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
      • Whittier, California, United States
        • Local Institution
    • Colorado
      • Lakewood, Colorado, United States
        • Local Institution
    • Florida
      • Boynton Beach, Florida, United States
        • Local Institution
      • Brooksville, Florida, United States
        • Local Institution
      • Inverness, Florida, United States
        • Local Institution
      • Pembroke Pines, Florida, United States
        • Local Institution
    • Georgia
      • Austell, Georgia, United States
        • Local Institution
    • Hawaii
      • Honolulu, Hawaii, United States
        • Local Institution
    • Illinois
      • Skokie, Illinois, United States
        • Local Institution
    • Indiana
      • Muncie, Indiana, United States
        • Local Institution
    • Maryland
      • Annapolis, Maryland, United States
        • Local Institution
      • Frederick, Maryland, United States
        • Local Institution
      • Rockville, Maryland, United States
        • Local Institution
    • Massachusetts
      • Plymouth, Massachusetts, United States
        • Local Institution
    • New Mexico
      • Farmington, New Mexico, United States
        • Local Institution
    • New York
      • Armonk, New York, United States
        • Local Institution
      • Stony Brook, New York, United States
        • Local Institution
    • North Carolina
      • Gastonia, North Carolina, United States
        • Local Institution
      • Wilmington, North Carolina, United States
        • Local Institution
    • North Dakota
      • Bismarck, North Dakota, United States
        • Local Institution
    • Ohio
      • Cincinnati, Ohio, United States
        • Local Institution
    • Oregon
      • Portland, Oregon, United States
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, United States
        • Local Institution
    • Texas
      • Dallas, Texas, United States
        • Local Institution
    • Washington
      • Vancouver, Washington, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
  • Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva).
  • Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease.
  • Must be able to carry out work of light or sedentary nature (e.g. light house work, office work).
  • It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial).
  • Symptomatic or uncontrolled metastases in the central nervous system (CNS).
  • Peripheral neuropathy.
  • Inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,500/mm^3, a platelet count <100,000/mm^3, or a hemoglobin level < 9g/dL.
  • Inadequate liver function.
  • Inadequate kidney function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Cetuximab + platinum + gemcitabine
Solution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance.
Other Names:
  • Erbitux
Active Comparator: B
Drug: Platinum + Gemcitabine
Solution, IV, Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
tumor response per treatment arm

Secondary Outcome Measures

Outcome Measure
disease control, symptom response, symptomatic progression, & progression free survival.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

June 1, 2005

First Submitted That Met QC Criteria

June 1, 2005

First Posted (Estimate)

June 2, 2005

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA225-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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