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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00191126
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : November 22, 2016
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: gemcitabine Drug: Cisplatin Procedure: surgery Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : September 2000
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: baseline to measure progressive disease ]

Secondary Outcome Measures :
  1. To compare the survival and sites of relapse in the two study arms. [ Time Frame: baseline to progressive disease ]
  2. Pharmacology toxicity [ Time Frame: every cycle ]
  3. Response rate [ Time Frame: baseline to measured progressive disease ]
  4. Pathologic response rate of tissue samples [ Time Frame: baseline, post chemotherapy, post surgery ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Publications of Results:
Responsible Party: Eli Lilly and Company Identifier: NCT00191126     History of Changes
Other Study ID Numbers: 3532
B9E-MC-S132 ( Other Identifier: Eli Lilly and Company )
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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