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A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02450539
Recruitment Status : Active, not recruiting
First Posted : May 21, 2015
Results First Posted : June 25, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer Stage IV
Interventions: Drug: Abemaciclib
Drug: Docetaxel

  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
Participants who completed were those who died due to any cause.

Reporting Groups
  Description
Abemaciclib 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Docetaxel 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Participant Flow:   Overall Study
    Abemaciclib   Docetaxel
STARTED   106   53 
Received at Least One Dose of Study Drug   106   52 
Death   56   20 
COMPLETED   56   20 
NOT COMPLETED   50   33 
Withdrawal by Subject                19                7 
Lost to Follow-up                4                1 
On study treatment/follow up                27                25 



  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
Abemaciclib 200 milligram(mg) Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Docetaxel 75 milligram per meter squared (mg/m²) Docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Total Total of all reporting groups

Baseline Measures
   Abemaciclib   Docetaxel   Total 
Overall Participants Analyzed 
[Units: Participants]
 106   53   159 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.1  (7.8)   64.5  (7.1)   63.5  (7.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   16   9   25 
Male   90   44   134 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   5   3   8 
Not Hispanic or Latino   84   48   132 
Unknown or Not Reported   17   2   19 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   0   0   0 
Asian   10   3   13 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   96   50   146 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Romania   18   4   22 
Hungary   7   6   13 
United States   4   2   6 
Ukraine   13   13   26 
Russia   11   2   13 
Spain   8   6   14 
South Korea   8   1   9 
Taiwan   2   2   4 
Poland   14   10   24 
Italy   7   1   8 
Australia   4   0   4 
France   1   2   3 
Germany   9   4   13 
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [1] 
[Units: Participants]
Count of Participants
     
 22   7   29 
 84   46   130 
[1] Participants were stratified at randomization according to the following: Eastern Cooperative Oncology Group (ECOG) PS (0 vs. 1); number of prior therapies (received only platinum-based therapy vs. platinum-based therapy plus immune checkpoint inhibitor) and time since initiation of first line therapy (<=9 months vs >9 months). The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.


  Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months) ]

2.  Secondary:   Pharmacokinetics (PK): Clearance of Abemaciclib   [ Time Frame: Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose ]

3.  Secondary:   PK: Volume of Distribution of Abemaciclib   [ Time Frame: Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose ]

4.  Secondary:   Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])   [ Time Frame: Baseline to Objective Progression (Up To 6 Months) ]

5.  Secondary:   Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)   [ Time Frame: Baseline through Measured Progressive Disease or Death Due to Any Cause (Up To 6 Months) ]

6.  Secondary:   Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2   [ Time Frame: Randomization to ECOG PFS of >/=2 (Up To 11.5 Months) ]

7.  Secondary:   Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores   [ Time Frame: Baseline through End of Study (Up To 6 Months) ]

8.  Secondary:   Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score   [ Time Frame: Baseline to Measured Progressive Disease (Up To 6 Months) ]

9.  Secondary:   Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value   [ Time Frame: Baseline to Measured Progressive Disease (Up To 6 Months) ]

10.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline to Date of Death from Any Cause (Approximately 11 Months) ]
Results not yet reported.   Anticipated Reporting Date:   07/2019  


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979
e-mail: ClinicalTrials.gov@lilly.com



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02450539     History of Changes
Other Study ID Numbers: 15806
I3Y-MC-JPBX ( Other Identifier: Eli Lilly and Company )
2014-004832-20 ( EudraCT Number )
First Submitted: May 19, 2015
First Posted: May 21, 2015
Results First Submitted: March 30, 2018
Results First Posted: June 25, 2018
Last Update Posted: August 13, 2018