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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 
Overall Participants Analyzed 
[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
No text entered.


  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