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First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker

NCT00455936 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2010-10-25

No results posted yet for this study

Summary

The investigators will conduct the randomized trial to determine the role of Gefitinib monotherapy as first-line setting in adenocarcinoma patients with no history of smoking, as compared with the standard combination chemotherapy.

This is a randomized, open label, parallel group, phase III study in never-smokers with advanced or metastatic adenocarcinoma of lung.

After stratification by gender, performance status, and disease stage, patients will be randomized to one of the two treatment arms to receive either gefitinib or standard chemotherapy until clinical or objective disease progression, unacceptable toxicity or patient's refusal, whichever is sooner. The chemotherapy will be administered for no more than nine cycles.

Conditions

Interventions

DRUG

Gefitinib

gefitinib 250mg tablet/ QD daily until Progression

PROCEDURE

chemotherapy

gemcitabine(1250mg/m2 iv on D1 \& 8) plus Cisplatin (80mg/m2 iv on D1) every 3 weeks, maximum 9 cycles

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Jin Soo Lee, M.D. · National Cancer Center, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2009-11-30
Completion
2010-03-31

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00455936 on ClinicalTrials.gov