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

Primary Purpose

Non-Small-Cell Lung Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cetuximab + platinum + gemcitabine
Platinum + Gemcitabine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma focused on measuring Non-Small Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

tumor response per treatment arm

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2005
Last Updated
October 26, 2015
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00112346
Brief Title
Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Carcinoma
Keywords
Non-Small Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cetuximab + platinum + gemcitabine
Other Intervention Name(s)
Erbitux
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Platinum + Gemcitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
tumor response per treatment arm
Secondary Outcome Measure Information:
Title
disease control, symptom response, symptomatic progression, & progression free survival.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Mobile
State/Province
Alabama
Country
United States
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Local Institution
City
Anchorage
State/Province
Alaska
Country
United States
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Local Institution
City
Bakersfield
State/Province
California
Country
United States
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Local Institution
City
Corona
State/Province
California
Country
United States
Facility Name
Local Institution
City
Oxnard
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Diego
State/Province
California
Country
United States
Facility Name
Local Institution
City
Whittier
State/Province
California
Country
United States
Facility Name
Local Institution
City
Lakewood
State/Province
Colorado
Country
United States
Facility Name
Local Institution
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Brooksville
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Inverness
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Austell
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
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City
Skokie
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Muncie
State/Province
Indiana
Country
United States
Facility Name
Local Institution
City
Annapolis
State/Province
Maryland
Country
United States
Facility Name
Local Institution
City
Frederick
State/Province
Maryland
Country
United States
Facility Name
Local Institution
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Local Institution
City
Plymouth
State/Province
Massachusetts
Country
United States
Facility Name
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City
Farmington
State/Province
New Mexico
Country
United States
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Armonk
State/Province
New York
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United States
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Stony Brook
State/Province
New York
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United States
Facility Name
Local Institution
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Gastonia
State/Province
North Carolina
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United States
Facility Name
Local Institution
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Wilmington
State/Province
North Carolina
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United States
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City
Bismarck
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North Dakota
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United States
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Local Institution
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Local Institution
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Vancouver
State/Province
Washington
Country
United States
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Local Institution
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Greenfield Park
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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