Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00556322
First received: November 9, 2007
Last updated: February 4, 2015
Last verified: February 2015
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: Alimta or Taxotere
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
No text entered.

Reporting Groups
  Description
Comparator Participants received either pemetrexed 500 milligrams per square meter (mg/m^2) every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Erlotinib Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.

Participant Flow:   Overall Study
    Comparator     Erlotinib  
STARTED     221     203  
COMPLETED     0 [1]   0 [1]
NOT COMPLETED     221     203  
Insufficient therapeutic response                 158                 168  
Adverse Event                 7                 4  
Unspecified                 4                 1  
Lost to Follow-up                 5                 3  
Withdrawal by Subject                 19                 7  
Protocol Violation                 5                 1  
Ongoing at data cutoff                 3                 5  
Death                 20                 14  
[1] Data cutoff was 01 August 2010



  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.
Full Analysis Set (FAS): All participants randomized were included according to the therapy that they were randomized to receive in the FAS population.

Reporting Groups
  Description
Comparator Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Erlotinib Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Total Total of all reporting groups

Baseline Measures
    Comparator     Erlotinib     Total  
Number of Participants  
[units: participants]
  221     203     424  
Age  
[units: years]
Mean ± Standard Deviation
  58.3  ± 9.90     58.6  ± 9.64     58.4  ± 9.76  
Gender  
[units: participants]
     
Female     61     42     103  
Male     160     161     321  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months ]

2.  Primary:   Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months ]

3.  Primary:   Probable Percentage of Participants Remaining Alive at 1 Year   [ Time Frame: 1 Year ]

4.  Secondary:   Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months ]

5.  Secondary:   Duration of OS in EGFR Positive and Negative Population   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months ]

6.  Secondary:   Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population   [ Time Frame: 1 Year ]

7.  Secondary:   Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months ]

8.  Secondary:   Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months ]

9.  Secondary:   Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months   [ Time Frame: 6 Months ]

10.  Secondary:   Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months ]

11.  Secondary:   PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months ]

12.  Secondary:   Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population   [ Time Frame: 6 Months ]

13.  Secondary:   Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Death or up to 52 months ]

14.  Secondary:   Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months ]

15.  Secondary:   Time to Deterioration in Quality of Life Using FACT-L   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months ]

16.  Secondary:   Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L   [ Time Frame: 6 Months ]

17.  Secondary:   Percentage of Participants With Symptomatic Progression Using FACT-L   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months ]

18.  Secondary:   Time to Symptomatic Progression Using FACT-L   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months ]

19.  Secondary:   Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L   [ Time Frame: 6 Months ]

20.  Secondary:   Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months ]

21.  Secondary:   Time to Deterioration in the TOI   [ Time Frame: Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months ]

22.  Secondary:   Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L   [ Time Frame: 6 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


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00556322     History of Changes
Other Study ID Numbers: BO18602
Study First Received: November 9, 2007
Results First Received: December 3, 2014
Last Updated: February 4, 2015
Health Authority: Slovenia: Ministry of Health