CClinicalTrials.gg
CompletedNCT00191841Updated Jul 24, 2006

Gemcitabine in Combination With Cisplatin as Neoadjuvant NSCLC Chemotherapy

A Phase 2 interventional study of gemcitabine and Cisplatin in Carcinoma, Non-Small-Cell Lung, sponsored by Eli Lilly and Company. Completed at 4 sites in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2006-07-24.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 50 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Concurrent administration of any other tumor therapy
  • pregnant or breast feeding
  • serious concomitant disorders
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants

Interventions

  • Druggemcitabine
  • DrugCisplatin
06

What researchers measure

Primary outcomes

  1. Antitumor activity

Secondary outcomes

  1. Duration of response, time to progressive disease, time to treatment failure

07

Study locations

4 sites
  • 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, Russian Federation
08

References and documents

Publications

  • Davidov MI, Polotzky BE, Marenich AF, Orlov SV, Lazarev AF, Skryabina LS, Pavlushkov EV, Semenchenya VA, Brichkova OY, Karaseva VV. Gemcitabine combined with cisplatin as neoadjuvant chemotherapy in stage IB-IIIA non-small cell lung cancer. Anticancer Drugs. 2011 Jul;22(6):569-75. doi: 10.1097/CAD.0b013e328342d50a. PubMed 21487288 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00191841
Lead sponsor
Eli Lilly and Company
First posted
Sep 19, 2005
Start date
Dec 2002
Completion
Feb 2006
Last update
Jul 24, 2006

Study contacts

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)
study director · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

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