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Erlotinib Therapy and Subsequent Development of Mechanisms of Secondary Resistance in Patients With NSCLC

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Genentech, Inc.
Information provided by (Responsible Party):
David M. Jackman, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00997334
First received: October 16, 2009
Last updated: February 28, 2017
Last verified: February 2017
Results First Received: January 5, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Intervention: Drug: Erlotinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study activated December 2009. Patients enrolled from February 2010 - January 2015

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
  Description
Erlotinib Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.

Participant Flow:   Overall Study
    Erlotinib
STARTED   60 
Eligible for Repeat Biopsy   44 [1] 
Evaluable   35 [2] 
COMPLETED   35 
NOT COMPLETED   25 
still on therapy                12 
Adverse Event                3 
Patient non-compliance                1 
Withdrawal by Subject                3 
Death                2 
Urgent Palliative Care                2 
No lesion amenable                1 
Ineligible                1 
[1] Patients who experience disease progression on treatment were eligible for repeat biopsy
[2] Patients with tissue available for re-biopsy at time of progression



  Baseline Characteristics
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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.
The analysis data is comprised of all treated patients

Reporting Groups
  Description
Erlotinib Patients receive standard dose of erlotinib 150mg daily with cycle length of 28 days; Patients are treated until disease progression or until unaccepted drug toxicity.

Baseline Measures
   Erlotinib 
Overall Participants Analyzed 
[Units: Participants]
 60 
Age 
[Units: Years]
Median (Full Range)
 60 
 (34 to 90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      44  73.3% 
Male      16  26.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   60 
Smoking Status 
[Units: Participants]
Count of Participants
 
Never-Smoker      34  56.7% 
Smoker      26  43.3% 


  Outcome Measures
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1.  Primary:   Resistance Mechanism   [ Time Frame: Participants were evaluated for incidence of genetic mechanisms of secondary resistance at time of disease progression at which point participants stopped treatment. Progression follow up was up to 3 years in this study cohort. ]

2.  Secondary:   Progression-Free Survival   [ Time Frame: Disease was evaluated radiologically every 8 weeks on treatment (cycle duration=4 weeks). Participants were treated until evidence of disease progression or unacceptable toxicity. Progression follow-up was up to 3 years in this study cohort. ]

3.  Post-Hoc:   Time to Repeat Biopsy   [ Time Frame: At time of removal from study, patients were asked to undergo a repeat biopsy of their progressing or new tumor lesion. Progression follow up was up to 3 years in this study cohort. ]

4.  Post-Hoc:   Feasibility Rate   [ Time Frame: Disease was evaluated radiologically every 8 weeks on treatment (cycle duration=4 weeks). Participants were treated until evidence of disease progression or unacceptable toxicity. Progression follow-up was up to 3 years in this study cohort. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: David M. Jackman, MD
Organization: Dana-Farber Cancer Institute
phone: 617.632.3468
e-mail: David_Jackman@dfci.harvard.edu


Publications of Results:

Responsible Party: David M. Jackman, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00997334     History of Changes
Other Study ID Numbers: 09-210
NE_OSI4590s ( Other Identifier: Genentech/Roche )
Study First Received: October 16, 2009
Results First Received: January 5, 2017
Last Updated: February 28, 2017