A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01250119
First received: November 29, 2010
Last updated: February 16, 2016
Last verified: February 2016
Results First Received: August 28, 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
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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
Non-small-cell Lung Cancer (NSCLC) Group During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
Erlotinib 150 Milligrams Per Day (mg/Day) During the Treatment Phase participants found to have a tumour with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until progressive disease (PD), death, unacceptable toxicity or withdrawal of consent.

Participant Flow for 2 periods

Period 1:   Diagnostic Phase
    Non-small-cell Lung Cancer (NSCLC) Group     Erlotinib 150 Milligrams Per Day (mg/Day)  
STARTED     688     0  
COMPLETED     575 [1]   0  
NOT COMPLETED     113     0  
Failed to Produce a Test Results                 69                 0  
Participants Not Tested                 44                 0  
[1] Completed refers to participants with both positive and negative EGFR mutation test result.

Period 2:   Treatment Phase
    Non-small-cell Lung Cancer (NSCLC) Group     Erlotinib 150 Milligrams Per Day (mg/Day)  
STARTED     0     41 [1]
COMPLETED     0     0  
NOT COMPLETED     0     41  
Progressive Disease                 0                 32  
Death                 0                 2  
Withdrawal by Subject                 0                 1  
Adverse Event                 0                 2  
Unknown reason                 0                 4  
[1] Out of 52 participants with positive EGFR mutation test result, only 41 participants were treated.



  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.
Diagnostic population: All participants newly diagnosed with recurrent or metastatic NSCLC who entered the study and signed the consent form were included in this population.

Reporting Groups
  Description
NSCLC Group During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.

Baseline Measures
    NSCLC Group  
Number of Participants  
[units: participants]
  688  
Age  
[units: years]
Mean (Standard Deviation)
  68.0  (10.0)  
Gender  
[units: participants]
 
Female     299  
Male     389  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Tested Positive for EGFR Mutations   [ Time Frame: 14 days ]

2.  Primary:   Percentage of Participants With EGFR Mutations by Subgroup   [ Time Frame: 14 Days ]

3.  Secondary:   Percentage of Participants With a Response by Best Objective Tumor Response   [ Time Frame: Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months ]

4.  Secondary:   Probability of Being Alive and Free of Progression by Timepoint   [ Time Frame: Months 0, 3, 6, 9, 12, 15, and 18 ]

5.  Secondary:   Survival Time in Months   [ Time Frame: Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months ]

6.  Secondary:   Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument   [ Time Frame: Screening, Baseline and Final or Withdrawal Visit up to 34 months ]

7.  Secondary:   Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D   [ Time Frame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months ]

8.  Secondary:   Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D   [ Time Frame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months ]

9.  Secondary:   Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D   [ Time Frame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months ]

10.  Secondary:   Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D   [ Time Frame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months ]

11.  Secondary:   Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D   [ Time Frame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 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: 1-800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01250119     History of Changes
Other Study ID Numbers: ML25279
2010-021120-96
Study First Received: November 29, 2010
Results First Received: August 28, 2015
Last Updated: February 16, 2016
Health Authority: United Kingdom: Ministry of Health