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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00191841
Other study ID # 7410
Secondary ID B9E-VI-S327
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated July 21, 2006
Start date December 2002
Est. completion date February 2006

Study information

Verified date July 2006
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority Russia: Pharmacological Committee, Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
gemcitabine

Cisplatin


Locations

Country Name City State
Russian Federation 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 Barnaul
Russian Federation 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 Moscow
Russian Federation 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 St Petersburg
Russian Federation 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

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antitumor activity
Secondary Duration of response, time to progressive disease, time to treatment failure
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