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A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01183858
First received: August 16, 2010
Last updated: July 23, 2015
Last verified: July 2015
Results First Received: February 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: 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
315 participants were randomized. 313 participants were included in the Intent-to -treat (ITT) population. The ITT population excluded 2 randomized participants: 1 participant randomized in error and 1 participant with missing source data.

Reporting Groups
  Description
Erlotinib 150 mg Erlotinib 150 mg single daily oral dose until disease progression.
Erlotinib 300 mg Erlotinib 300 mg single daily oral dose until disease progression.

Participant Flow:   Overall Study
    Erlotinib 150 mg     Erlotinib 300 mg  
STARTED     154     159  
Safety Population     154     158  
COMPLETED     1     3  
NOT COMPLETED     153     156  
Death not related to Progressive Disease                 5                 6  
Adverse Event                 14                 11  
Investigator's Decision                 0                 3  
Insufficient Therapeutic Response                 2                 0  
Refused Treatment                 1                 4  
Withdrew Consent                 4                 4  
Discontinued Smoking                 3                 1  
Protocol Violation                 1                 0  
Administrative/Other                 6                 6  
Progressive Disease                 112                 115  
Death related to Progressive Disease                 4                 5  
Lost to Follow-up                 1                 1  



  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 Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.

Reporting Groups
  Description
Erlotinib 150 mg Erlotinib 150 mg single daily oral dose until disease progression.
Erlotinib 300 mg Erlotinib 300 mg single daily oral dose until disease progression.
Total Total of all reporting groups

Baseline Measures
    Erlotinib 150 mg     Erlotinib 300 mg     Total  
Number of Participants  
[units: participants]
  154     159     313  
Age  
[units: years]
Mean (Standard Deviation)
  59.7  (9.25)     59.2  (9.14)     59.4  (9.18)  
Gender  
[units: participants]
     
Female     34     35     69  
Male     120     124     244  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months) ]

2.  Primary:   Progression-Free Survival (PFS) at the End of Study   [ Time Frame: Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 months) ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) ]

4.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) ]

5.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) ]

6.  Secondary:   Time to Progression (TTP)   [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) ]

7.  Secondary:   Number of Participants With Adverse Events (AEs) at the End of the Study   [ Time Frame: Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 months) ]

8.  Secondary:   Overall Survival (OS) at the End of Study   [ Time Frame: Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 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-La Roche
phone: 800-821-8590
e-mail: genetech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01183858     History of Changes
Other Study ID Numbers: MO22162
2010-018476-24 ( EudraCT Number )
Study First Received: August 16, 2010
Results First Received: February 5, 2015
Last Updated: July 23, 2015
Health Authority: Spain: Agencia Española del Medicamento y Productos sanitarios (AEMPS)