A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00257608
First received: November 21, 2005
Last updated: March 18, 2016
Last verified: March 2016
Results First Received: November 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: bevacizumab
Drug: placebo
Drug: erlotinib HCl

  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
This study was conducted in 14 countries between 10 January 2006 and 19 June 2009.

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
Bevacizumab + Chemotherapy Participants received one of six chemotherapy regimens (Carboplatin + Paclitaxel or Carboplatin + Gemcitabine or Carboplatin + Docetaxel or Cisplatin + Gemcitabine or Cisplatin + Docetaxel / Cisplatin + vinorelbine) followed by Bevacizumab on Day 1 of each cycle up to 4 cycles.
Bevacizumab + Placebo Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
Bevacizumab + Erlotinib Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.

Participant Flow for 2 periods

Period 1:   Chemotherapy Phase
    Bevacizumab + Chemotherapy     Bevacizumab + Placebo     Bevacizumab + Erlotinib  
STARTED     1145     0     0  
COMPLETED     769     0     0  
NOT COMPLETED     376     0     0  
Adverse Event                 138                 0                 0  
Disease progression                 139                 0                 0  
Unwillingness or inability to comply                 6                 0                 0  
Need for concomitant/ancillary therapy                 27                 0                 0  
Patient's decision to discontinue                 35                 0                 0  
Unrelated intercurrent illness                 3                 0                 0  
Physician Decision                 28                 0                 0  

Period 2:   Post Chemotherapy Phase
    Bevacizumab + Chemotherapy     Bevacizumab + Placebo     Bevacizumab + Erlotinib  
STARTED     0     373     370  
COMPLETED     0     109     126  
NOT COMPLETED     0     264     244  
Adverse Event                 0                 34                 38  
Disease progression                 0                 204                 168  
Unwillingness or inability to comply                 0                 4                 5  
Need for concomitant/ancillary therapy                 0                 5                 5  
Patient's decision to discontinue                 0                 4                 8  
Unrelated intercurrent illness                 0                 0                 1  
Lost to Follow-up                 0                 0                 1  
Physician Decision                 0                 8                 11  
Sponsor's decision to terminate study                 0                 1                 0  
Not treated                 0                 4                 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.
No text entered.

Reporting Groups
  Description
Bevacizumab + Placebo Participants received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily
Bevacizumab + Erlotinib Participants received Bevacizumab 15 mg/kg IV on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily
Total Total of all reporting groups

Baseline Measures
    Bevacizumab + Placebo     Bevacizumab + Erlotinib     Total  
Number of Participants  
[units: participants]
  373     370     743  
Age  
[units: Years]
Mean (Standard Deviation)
  62.8  (10.8)     62.9  (10.3)     62.9  (10.6)  
Gender  
[units: participants]
     
Female     177     177     354  
Male     196     193     389  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Approximately 3 years ]

2.  Secondary:   Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase   [ Time Frame: Approximately 3 years ]

3.  Secondary:   Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase   [ Time Frame: Approximately 3 years ]

4.  Secondary:   Number of Participants With Any Adverse Events During Post-Chemotherapy Phase   [ Time Frame: Approximately 3.5 years ]

5.  Secondary:   Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase   [ Time Frame: Approximately 3 years ]

6.  Secondary:   Incidence of Study Treatment Discontinuation   [ Time Frame: Approximately 3 years ]

7.  Secondary:   Overall Survival   [ Time Frame: Approximately 3.5 years ]


  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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00257608     History of Changes
Other Study ID Numbers: AVF3671g
BO20800 ( Other Identifier: Hoffmann-La Roche )
Study First Received: November 21, 2005
Results First Received: November 9, 2015
Last Updated: March 18, 2016
Health Authority: United States: Food and Drug Administration