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A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01846416
First received: May 1, 2013
Last updated: May 5, 2017
Last verified: May 2017
Results First Received: October 24, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Intervention: Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

  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
Overall 201 participants were screened for clinical eligibility, out of which 63 participants were screen failures, and hence 138 participants were enrolled, and 137 participants received treatment. Analysis was performed until primary analysis cut-off date 7 January 2015 (approximately 20 months duration).

Reporting Groups
  Description
Atezolizumab (MPDL3280) : 1L Participants Participants with no prior chemotherapy for advanced non-small cell lung cancer (NSCLC) disease received atezolizumab intravenously (IV) as a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until disease progression.
Atezolizumab (MPDL3280): 2L+ Participants Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.

Participant Flow:   Overall Study
    Atezolizumab (MPDL3280) : 1L Participants   Atezolizumab (MPDL3280): 2L+ Participants   Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants
STARTED   31   93   13 
COMPLETED   0   0   0 
NOT COMPLETED   31   93   13 
Death                8                43                9 
Withdrawal by Subject                1                7                0 
Unspecified                1                0                0 
Ongoing as of 7 January 2015                21                41                3 
Lost to Follow-up                0                2                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.
All participants who received any dose of atezolizumab during the study.

Reporting Groups
  Description
Atezolizumab (MPDL3280) : 1L Participants Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Atezolizumab (MPDL3280) : 2L+ Participants Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Total Total of all reporting groups

Baseline Measures
   Atezolizumab (MPDL3280) : 1L Participants   Atezolizumab (MPDL3280) : 2L+ Participants   Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   93   13   137 
Age 
[Units: Years]
Mean (Standard Deviation)
 68  (10.8)   65.2  (9.3)   63.8  (7.7)   65.7  (9.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      17  54.8%      34  36.6%      7  53.8%      58  42.3% 
Male      14  45.2%      59  63.4%      6  46.2%      79  57.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months) ]

2.  Secondary:   Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)   [ Time Frame: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months) ]

3.  Secondary:   Duration of Objective Response According to RECIST v1.1   [ Time Frame: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months) ]

4.  Secondary:   Percentage of Participants With 6-Month Duration of Objective Response   [ Time Frame: Month 6 ]

5.  Secondary:   Percentage of Participants With Disease Progression or Death According to RECIST v1.1   [ Time Frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) ]

6.  Secondary:   Progression-Free Survival (PFS) According to RECIST v1.1   [ Time Frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) ]

7.  Secondary:   Percentage of Participants With PFS at Month 6 and Month 12 According to RECIST v1.1   [ Time Frame: Months 6 and 12 ]

8.  Secondary:   Percentage of Participants With Disease Progression or Death According to Modified RECIST   [ Time Frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) ]

9.  Secondary:   PFS According to Modified RECIST   [ Time Frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) ]

10.  Secondary:   Percentage of Participants With PFS at Month 6 and Month 12 According to Modified RECIST   [ Time Frame: Months 6 and 12 ]

11.  Secondary:   Percentage of Participants With Death   [ Time Frame: Baseline till death or up to 20 months, whichever occurred first ]

12.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline till death or up to 20 months, whichever occurred first ]

13.  Secondary:   Maximum Plasma Concentration (Cmax) for Atezolizumab   [ Time Frame: Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1 ]

14.  Secondary:   Minimum Plasma Concentration (Cmin) for Atezolizumab   [ Time Frame: Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16 ]


  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
Not specified.


  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: genentech@druginfo.com



Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01846416     History of Changes
Other Study ID Numbers: GO28625
2013-000177-69 ( EudraCT Number )
Study First Received: May 1, 2013
Results First Received: October 24, 2016
Last Updated: May 5, 2017