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

Phase 2

Completed

• Conditions: Non-Small-Cell Lung Carcinoma
• Interventions: Drug: Cetuximab + platinum + gemcitabine; Drug: Platinum + Gemcitabine

• Registration Number: NCT00112346
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-06-01
• Study First Submitted QC: 2005-06-01
• Study First Posted: 2005-06-02
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Cetuximab + platinum + gemcitabine	-
B	Platinum + Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
tumor response per treatment arm

Secondary Outcome Measures

Name	Time	Method
disease control, symptom response, symptomatic progression, & progression free survival.

Trial Locations

Locations (1)

Local Institution; 🇨🇦 Greenfield Park, Quebec, Canada