Gemcitabine in Combination With Cisplatin as Neoadjuvant NSCLC Chemotherapy

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT00191841
• Lead Sponsor: Eli Lilly and Company

Brief Summary

To evaluate the clinical response rate of neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with operable NSCLC

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-02
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-21
• Last Update Posted: 2006-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• histologic or cytologic diagnosis of operable non-small cell lung cancer (IB-IIIA)
• no prior chemotherapy
• WHO criteria for disease status assessment

Exclusion Criteria

• Concurrent administration of any other tumor therapy
• pregnant or breast feeding
• serious concomitant disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Antitumor activity

Secondary Outcome Measures

Name	Time	Method
Duration of response, time to progressive disease, time to treatment failure

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician; 🇷🇺 Ufa, Russian Federation