Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer

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: NCT00385996
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : November 14, 2012
Last Update Posted : December 19, 2012
OSI Pharmaceuticals
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma, Non-small Cell Lung
Intervention: Drug: Tarceva (Erlotinib)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from 10/13/06 to 10/8/08. Patients were recruited from the Weill Cornell Medical College Thoracic Surgery outpatient office.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Erlotinib Erlotinib 150 mg po daily.

Participant Flow:   Overall Study

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Erlotinib Erlotinib 150 mg po daily

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (56 to 82) 
[Units: Participants]
Female   11 
Male   11 
Region of Enrollment 
[Units: Participants]
United States   22 

  Outcome Measures

1.  Primary:   Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction.   [ Time Frame: High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®. ]

2.  Primary:   Safety of Tarceva in the Neoadjuvant Setting   [ Time Frame: From the onset of the AE until 30 days after the last study drug dose, until recovery is noted, or until the Investigator determines the patient's condition is stable. ]

3.  Secondary:   Time-to-progression and Disease-free Survival.   [ Time Frame: Every 3 months for the first 6 months, then yearly for 2 years. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Safety   [ Time Frame: Day 1 of treatment to 2 years. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Nasser Altorki, MD
Organization: Weill Cornell Medical College
phone: 212-746-5156

Responsible Party: Weill Medical College of Cornell University Identifier: NCT00385996     History of Changes
Other Study ID Numbers: OSI TAR 728
First Submitted: October 9, 2006
First Posted: October 11, 2006
Results First Submitted: October 12, 2012
Results First Posted: November 14, 2012
Last Update Posted: December 19, 2012