Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

This study has been completed.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: June 20, 2008
Last verified: June 2008

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.

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: gemcitabine
Drug: Cisplatin
Procedure: surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: baseline to measure progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the survival and sites of relapse in the two study arms. [ Time Frame: baseline to progressive disease ] [ Designated as safety issue: No ]
  • Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Pathologic response rate of tissue samples [ Time Frame: baseline, post chemotherapy, post surgery ] [ Designated as safety issue: No ]

Enrollment: 263
Study Start Date: September 2000
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A Procedure: surgery
Experimental: B Drug: gemcitabine
1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles
Other Names:
  • LY188011
  • Gemzar
Drug: Cisplatin
75 mg/m2, IV, q 21 days x 3 cycles
Procedure: surgery


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191126

  Show 37 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Study Chair: 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) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191126     History of Changes
Other Study ID Numbers: 3532, B9E-MC-S132
Study First Received: September 12, 2005
Last Updated: June 20, 2008
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014