We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351415
First Posted: May 10, 2011
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
Results First Submitted: June 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Squamous Non-Small Cell Lung Cancer
Interventions: Drug: Bevacizumab
Drug: Docetaxel
Drug: Erlotinib
Drug: Pemetrexed

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This phase 3b study was conducted across 16 different countries and enrolled 485 participants. Participants were 18 years or older and had locally recurrent or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 485 participants were enrolled and randomized into the study. Of these, 475 participants were treated; 243 participants received bevacizumab plus standard of care (SoC) and 232 participants received SoC alone. The study was terminated 60 months after study start, as per protocol, but was not ended prematurely.

Reporting Groups
  Description
Bevacizumab + Standard of Care Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
Standard of Care Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).

Participant Flow:   Overall Study
    Bevacizumab + Standard of Care   Standard of Care
STARTED   245   240 
Treated Participants   243   232 
COMPLETED   0   0 
NOT COMPLETED   245   240 
Withdrawal by Subject                15                17 
Trial termination by the Sponsor                28                19 
Lost to Follow-up                5                7 
Death                190                187 
Physician Decision                2                3 
Reason unknown                0                2 
Never Started                5                5 



  Baseline Characteristics
  Hide Baseline Characteristics

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 includes all randomized participants.

Reporting Groups
  Description
Bevacizumab + Standard of Care Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
Standard of Care Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
Total Total of all reporting groups

Baseline Measures
   Bevacizumab + Standard of Care   Standard of Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 245   240   485 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.5  (9.61)   61.8  (9.29)   61.6  (9.44) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      90  36.7%      102  42.5%      192  39.6% 
Male      155  63.3%      138  57.5%      293  60.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]

2.  Secondary:   Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)   [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]

3.  Secondary:   Percentage of Participants With Objective Response According to RECIST v1.1   [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]

4.  Secondary:   Percentage of Participants With Disease Control According to RECIST v1.1   [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]

5.  Secondary:   Duration of Response (DoR) According to RECIST v1.1   [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]

6.  Secondary:   Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]

7.  Secondary:   Time to Progression (TTP) According to RECIST v1.1   [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]

8.  Secondary:   Percentage of Participants Who Are Alive at Month 6, 12, and 18   [ Time Frame: Month 6, 12, 18 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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: 888-6821-8590
e-mail: genentech@druginfo.com


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01351415     History of Changes
Other Study ID Numbers: MO22097
2010-022645-14 ( EudraCT Number )
First Submitted: May 9, 2011
First Posted: May 10, 2011
Results First Submitted: June 20, 2017
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017



To Top