Official Title: “Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages(T2N0, T1 - 2N1, T3N0 AND T3N1) Non-Small Cell Lung Cancer (NSCLC)”

Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2007

Intervention(s) in this Clinical Trial

• Drug: gemcitabine
  • 1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles
• Drug: Cisplatin
  • 75 mg/m2, IV, q 21 days x 3 cycles
• Procedure: surgery
  • surgery

Arms, Groups and Cohorts in this Clinical Trial

• Other: A
• Experimental: B

Primary Measures

• Progression free survival
  • Time Frame: baseline to measure progressive disease
    Safety Issue?: No

Secondary Measures

• To compare the survival and sites of relapse in the two study arms.
  • Time Frame: baseline to progressive disease
    Safety Issue?: No
• Pharmacology toxicity
  • Time Frame: every cycle
    Safety Issue?: Yes
• Response rate
  • Time Frame: baseline to measured progressive disease
    Safety Issue?: No
• Pathologic response rate of tissue samples
  • Time Frame: baseline, post chemotherapy, post surgery
    Safety Issue?: No

Main inclusion Criteria:

• Must have pathologic documentation of non-small cell lung cancer, IB, II, IIIA.
• ECOG Performance Status of 0 - 1
• Bidimensionally measurable disease or evaluable disease
• Adequate organ function

Main exclusion Criteria:

• Have greater than Grade 1 neuropathy - motor/sensory
• Significant history of cardiac disease
• Pleural effusion

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and 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 Chair Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00191126

Study ID Number: 3532

ClinicalTrials.gov Identifier: NCT00191126

Health Authority: Italy: Ministry of Health

Lilly Clinical Trial Registry