A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01378962
First received: June 21, 2011
Last updated: May 27, 2016
Last verified: May 2016
Results First Received: September 30, 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
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Reporting Groups
  Description
Erlotinib 150 mg Erlotinib 150 milligrams (mg) tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.

Participant Flow:   Overall Study
    Erlotinib 150 mg  
STARTED     50  
COMPLETED     33  
NOT COMPLETED     17  
Death                 14  
Lost to Follow-up                 1  
Unspecified                 2  



  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.
Safety population included all participants enrolled in the study who received at least 1 dose of treatment and had at least 1 safety assessment.

Reporting Groups
  Description
Erlotinib 150 mg Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.

Baseline Measures
    Erlotinib 150 mg  
Number of Participants  
[units: participants]
  50  
Age  
[units: years]
Mean (Standard Deviation)
  62.86  (11.42)  
Gender  
[units: participants]
 
Female     34  
Male     16  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Disease Progression or Death at 12 Months After Baseline   [ Time Frame: 12 months ]

2.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Up to 1 year after enrollment of the last participant (maximum up to 27 months) ]

3.  Primary:   Probability of Being Progression Free 12 Months After Baseline   [ Time Frame: 12 months ]

4.  Secondary:   Percentage of Participants Who Died   [ Time Frame: Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months) ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months) ]

6.  Secondary:   Percentage of Participants With a Response by Best Overall Response   [ Time Frame: Baseline up to disease progression or end of study (up to 12 Months) ]

7.  Secondary:   Percentage of Participants With Objective Response   [ Time Frame: Baseline up to disease progression or end of study (up to 12 Months) ]

8.  Secondary:   Percentage of Participants Achieving CR, PR, or SD as Best Overall Response   [ Time Frame: Baseline up to disease progression or end of study (up to 12 Months) ]

9.  Secondary:   Percentage of Participants With Primary and Secondary Resistance   [ Time Frame: Baseline up to disease progression (up to 12 Months) ]

10.  Secondary:   Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type   [ Time Frame: Baseline, At progression of disease (up to 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: NCT01378962     History of Changes
Other Study ID Numbers: ML25514
Study First Received: June 21, 2011
Results First Received: September 30, 2015
Last Updated: May 27, 2016
Health Authority: Italy: Ministry of Health