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A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609543
First received: May 30, 2012
Last updated: December 29, 2015
Last verified: December 2015
Results First Received: December 29, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Squamous Non-Small Cell Lung Cancer
Intervention: Drug: erlotinib [Tarceva]

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 651 participants were screened and among them 62 participants were enrolled in the study.

Reporting Groups
  Description
Erlotinib Hydrochloride Participants received a single 150 milligrams (mg) oral dose of erlotinib hydrochloride (Tarceva) tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.

Participant Flow:   Overall Study
    Erlotinib Hydrochloride
STARTED   62 
COMPLETED   20 
NOT COMPLETED   42 
Disease Progression                28 
Adverse Event                5 
Withdrawal by Subject                1 
Protocol Violation                1 
Death                7 



  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.
Intent-to-treat (ITT) population included all enrolled participants.

Reporting Groups
  Description
Erlotinib Hydrochloride Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.

Baseline Measures
   Erlotinib Hydrochloride 
Overall Participants Analyzed 
[Units: Participants]
 62 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.69  (10.562) 
Gender 
[Units: Participants]
 
Female   50 
Male   12 


  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline to progressive disease or death (up to 34 months) ]

2.  Secondary:   Percentage of Participants With Best Overall Response (BOR)   [ Time Frame: Baseline to progressive disease or death (up to 34 months) ]

3.  Secondary:   Percentage of Participants Who Were Alive at 1 Year   [ Time Frame: 1 Year (12 months) ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01609543     History of Changes
Other Study ID Numbers: ML27880
2011-002168-26 ( EudraCT Number )
Study First Received: May 30, 2012
Results First Received: December 29, 2015
Last Updated: December 29, 2015
Health Authority: Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines