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An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

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ClinicalTrials.gov Identifier: NCT02041533
Recruitment Status : Active, not recruiting
First Posted : January 22, 2014
Results First Posted : July 26, 2017
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Stage IV or Recurrent Non-Small Cell Lung Cancer
Interventions: Biological: Nivolumab
Drug: Gemcitabine
Drug: Cisplatin
Drug: Carboplatin
Drug: Paclitaxel
Drug: Pemetrexed

  Participant Flow

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
1325 participants were enrolled; 541 were randomized to a treatment group; 530 were treated. Participants were randomized but not treated due to disease progression (n=2), withdrawal of consent (n=5), or they no longer met study criteria (n=4)

Reporting Groups
  Description
Nivolumab Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
Investigator Choice of Chemotherapy

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).

Participant Flow:   Overall Study
    Nivolumab   Investigator Choice of Chemotherapy
STARTED   271   270 
Began Treatment   267   263 
COMPLETED   43 [1]   12 [1] 
NOT COMPLETED   228   258 
Disease Progression                168                142 
Study drug toxicity                27                30 
Death                1                0 
Adverse Event unrelated to study drug                20                21 
Subject request to discontinue treatment                5                9 
Withdrawal by Subject                2                1 
Maximum clinical benefit                0                18 
Poor/non-compliance                1                0 
Other reasons                0                1 
Completed max number of chemo cycles                0                29 
Randomized, not treated                4                7 
[1] Completed = Participants continuing in the treatment period



  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.
All randomized participants

Reporting Groups
  Description
Nivolumab Nivolumab 3mg/kg IV infusion, every 2 weeks until disease progression or unacceptable toxicity
Investigator Choice of Chemotherapy

Investigators' choice of chemotherapy was administered in 3-week cycles for up to 6 cycles:

Squamous:

  • gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
  • gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
  • paclitaxel (200 mg/m2) with carboplatin (AUC 6)

Non-Squamous:

  • pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
  • pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total).
Total Total of all reporting groups

Baseline Measures
   Nivolumab   Investigator Choice of Chemotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 271   270   541 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.8  (10.25)   63.4  (9.63)   63.1  (9.94) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      87  32.1%      122  45.2%      209  38.6% 
Male      184  67.9%      148  54.8%      332  61.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      4   1.5%      3   1.1%      7   1.3% 
Not Hispanic or Latino      141  52.0%      139  51.5%      280  51.8% 
Unknown or Not Reported      126  46.5%      128  47.4%      254  47.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   0.4%      0   0.0%      1   0.2% 
Asian      30  11.1%      17   6.3%      47   8.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      6   2.2%      10   3.7%      16   3.0% 
White      228  84.1%      242  89.6%      470  86.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      6   2.2%      1   0.4%      7   1.3% 


  Outcome Measures

1.  Primary:   Progression-Free Survival in Participants With PD-L1 Expression >= 5%   [ Time Frame: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months) ]

2.  Secondary:   Progression-Free Survival in All Randomized Participants   [ Time Frame: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months) ]

3.  Secondary:   Overall Survival in Participants With PD-L1 Expression >= 5%   [ Time Frame: From date of randomization to date of death (assessed up to August 2016, approximately 28 months) ]

4.  Secondary:   Overall Survival in All Randomized Participants   [ Time Frame: From date of randomization to date of death (assessed up to August 2016, approximately 28 months) ]

5.  Secondary:   Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%   [ Time Frame: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months) ]

6.  Secondary:   Duration of Response in Participants With PD-L1 Expression>= 5%   [ Time Frame: From date of first confirmed response to date of tumor progression (Assessed up to August 2016, approximately 28 months) ]

7.  Secondary:   Time to Response in Participants With PD-L1 Expression >= 5%   [ Time Frame: From date of randomization to date of first confirmed response (assessed up to August 2016, approximately 18 months) ]

8.  Secondary:   Disease-related Symptom Improvement Rate by Week 12   [ Time Frame: From date of randomization to week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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

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: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


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

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02041533     History of Changes
Other Study ID Numbers: CA209-026
2012-004502-93 ( EudraCT Number )
First Submitted: January 19, 2014
First Posted: January 22, 2014
Results First Submitted: June 26, 2017
Results First Posted: July 26, 2017
Last Update Posted: February 14, 2018