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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 (Responsible Party):
Eli Lilly and Company Identifier:
First received: September 12, 2005
Last updated: November 21, 2016
Last verified: November 2016
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
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 ]

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

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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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:
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 )
Study First Received: September 12, 2005
Last Updated: November 21, 2016
Individual Participant Data  
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 processed this record on April 26, 2017