ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study in Non-Small Cell Lung Cancer

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.
ClinicalTrials.gov Identifier: NCT01232452
Recruitment Status : Completed
First Posted : November 2, 2010
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
ImClone LLC
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 Carcinoma
Interventions: Drug: Pemetrexed
Drug: Cisplatin
Drug: Cixutumumab

  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
Completers are those participants who died or had progressive disease (PD).

Reporting Groups
  Description
Pemetrexed + Cisplatin + Cixutumumab

Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 plus cixutumumab 20 mg/kg given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.

Maintenance Therapy: Pemetrexed 500 mg/m^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Pemetrexed + Cisplatin

Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 given IV on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.

Maintenance Therapy: Pemetrexed 500 mg/m^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.


Participant Flow:   Overall Study
    Pemetrexed + Cisplatin + Cixutumumab   Pemetrexed + Cisplatin
STARTED   87   85 
Received at Least One Dose of Study Drug   85   81 
COMPLETED   48   46 
NOT COMPLETED   39   39 
Adverse Event                17                15 
Withdrawal by Subject                11                8 
Physician Decision                8                12 
Protocol entry criterion not met                0                2 
Sponsor Decision                3                1 
Protocol Violation                0                1 



  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.
No text entered.

Reporting Groups
  Description
Pemetrexed + Cisplatin + Cixutumumab

Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 plus cixutumumab 20 mg/kg given IV on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.

Maintenance Therapy: Pemetrexed 500 mg/m^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Pemetrexed + Cisplatin

Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 given IV on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for participants with significant tumor size reduction, after sponsor approval.

Maintenance Therapy: Pemetrexed 500 mg/m^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Total Total of all reporting groups

Baseline Measures
   Pemetrexed + Cisplatin + Cixutumumab   Pemetrexed + Cisplatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 87   85   172 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   87   85   172 
   59.5  (9.87)   59.3  (9.96)   59.4  (9.89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   87   85   172 
Female      33  37.9%      32  37.6%      65  37.8% 
Male      54  62.1%      53  62.4%      107  62.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   87   85   172 
Hispanic or Latino      13  14.9%      24  28.2%      37  21.5% 
Not Hispanic or Latino      45  51.7%      33  38.8%      78  45.3% 
Unknown or Not Reported      29  33.3%      28  32.9%      57  33.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   87   85   172 
American Indian or Alaska Native      0   0.0%      1   1.2%      1   0.6% 
Asian      1   1.1%      0   0.0%      1   0.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   1.1%      2   2.4%      3   1.7% 
White      81  93.1%      80  94.1%      161  93.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      4   4.6%      2   2.4%      6   3.5% 
Region of Enrollment [1] 
[Units: Participants]
Count of Participants
     
Canada       
Participants Analyzed   1   1   2 
Canada   1   1   2 
Netherlands       
Participants Analyzed   4   1   5 
Netherlands   4   1   5 
Argentina       
Participants Analyzed   5   8   13 
Argentina   5   8   13 
Turkey       
Participants Analyzed   5   7   12 
Turkey   5   7   12 
Belgium       
Participants Analyzed   7   6   13 
Belgium   7   6   13 
United States       
Participants Analyzed   9   11   20 
United States   9   11   20 
Brazil       
Participants Analyzed   13   21   34 
Brazil   13   21   34 
Italy       
Participants Analyzed   9   8   17 
Italy   9   8   17 
Israel       
Participants Analyzed   6   2   8 
Israel   6   2   8 
France       
Participants Analyzed   3   2   5 
France   3   2   5 
Germany       
Participants Analyzed   17   8   25 
Germany   17   8   25 
Spain       
Participants Analyzed   6   6   12 
Spain   6   6   12 
[1] All randomized participants who received one dose of study drug and had evaluable Region of Enrollment data.


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Randomization Date to Disease Progression or Death From Any Cause Up to 18.3 Months ]

2.  Secondary:   Percentage of Participants Achieving an Objective Response Rate (ORR)   [ Time Frame: Randomization to Disease Progression Up to 18.3 Months ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Randomization Date to Death From Any Cause Up to 20 Months ]

4.  Secondary:   Duration of Response (DOR)   [ Time Frame: Time from Response to Disease Progression or Death from Any Cause Up to 20 Months ]

5.  Secondary:   Time to Progressive Disease (TTPS)   [ Time Frame: Randomization Date to Disease Progression Up to 18.3 Months ]

6.  Secondary:   Time to Worsening of Symptoms as Measured by Lung Cancer Symptom Scale (LCSS) Score   [ Time Frame: Time to worsening of symptoms as measured by LCSS score Up to 18.3 Months ]

7.  Secondary:   Change in Tumor Size (CTS)   [ Time Frame: Change from baseline measurement to the end of Cycle 2, average of 42 days ]

8.  Secondary:   Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Cixutumumab, Cycle 1 (First Infusion) and Cycle 4 (Fourth Infusion)   [ Time Frame: First Infusion: [Prior to Infusion (of Cycle1): 1, 72, 168, 336 hours(hrs) and 504 hrs (i.e. Prior to Infusion of Cycle 2)] and Fourth Infusion; [Prior to Infusion (of Cycle 4),1,24,72,120,168,240,336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 5)] ]

9.  Secondary:   PK: Area Under the Concentration Time Curve (AUC[0-inf]) of Cixutumumab, Cycle 1 (i.e. First Infusion)   [ Time Frame: Prior to Infusion (of Cycle 1), 1, 72, 168, 336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 2) ]

10.  Secondary:   PK: Area Under the Concentration Time Curve During 1 Dosing Interval (i.e. 504 hr, AUC(0-tau) of Cixutumumab, Cycle 4 (i.e. Fourth Infusion)   [ Time Frame: Prior to Infusion (of Cycle 4), 1, 24, 72, 120, 168, 240, 336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 5) ]

11.  Secondary:   Pharmacodynamics (PD) Markers: Free Insulin-like Growth Factor-I (IGF-I, Total IGF-I, and IGF Binding Proteins (IGFBP-3)   [ Time Frame: Preinfusion, Cycle 2, Cycle 4, Cycle 8, Postinfusion, 30-Day Follow-Up ]

12.  Secondary:   Immunogenicity of Cixutumumab   [ Time Frame: Preinfusion, Cycle1(C1): 1, 72, 168, 240, 336 hours(hrs); C2 and C3: 1, 168, 336 hrs; C4: 1, 24,72,120,168, 240, 336, 504 hrs, Postinfusion; 30 Day Follow Up ]


  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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01232452     History of Changes
Other Study ID Numbers: 13973
I5A-MC-JAEM ( Other Identifier: Eli Lilly and Company )
First Submitted: October 28, 2010
First Posted: November 2, 2010
Results First Submitted: March 17, 2018
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018