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First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (SQUIRE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Parexel
PPD
Medidata Solutions
Laboratory Corporation of America
University of Colorado, Denver
Thermo Fisher Scientific
ICON Clinical Research
Pacific Biomarkers
Sysmex Inostics GmbH
Intertek
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00981058
First received: September 18, 2009
Last updated: September 12, 2016
Last verified: September 2016
Results First Received: December 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Interventions: Biological: Necitumumab
Drug: Gemcitabine
Drug: Cisplatin

  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
Participants who completed the study include those who died due to any cause or were alive and on study at conclusion, but off treatment.

Reporting Groups
  Description
Necitumumab + Gemcitabine + Cisplatin

Necitumumab + Gemcitabine + Cisplatin

Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.

Continues until progressive disease, toxicity, noncompliance, or withdrawal.

Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.

Continues for a maximum of six cycles.

Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.

Continues for a maximum of six cycles.

Gemcitabine + Cisplatin

Gemcitabine + Cisplatin

Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.

Continues for a maximum of six cycles.

Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.

Continues for a maximum of six cycles.


Participant Flow:   Overall Study
    Necitumumab + Gemcitabine + Cisplatin   Gemcitabine + Cisplatin
STARTED   545   548 
Received at Least 1 Dose of Study Drug   538   541 
Death Due to Any Cause   418   442 
COMPLETED   425   451 
NOT COMPLETED   120   97 
Adverse Event                1                1 
Progressive Disease                61                49 
Lost to Follow-up                16                15 
New Anticancer Therapy                6                6 
Noncompliance                1                0 
Radiologist Error                0                1 
Randomization Error                1                2 
Withdrawal by Subject                25                23 
On study treatment at conclusion                9                0 



  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.
No text entered.

Reporting Groups
  Description
Necitumumab + Gemcitabine + Cisplatin

Necitumumab + Gemcitabine + Cisplatin

Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.

Continues until progressive disease, toxicity, noncompliance, or withdrawal.

Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.

Continues for a maximum of six cycles.

Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.

Continues for a maximum of six cycles.

Gemcitabine + Cisplatin

Gemcitabine + Cisplatin

Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.

Continues for a maximum of six cycles.

Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.

Continues for a maximum of six cycles.

Total Total of all reporting groups

Baseline Measures
   Necitumumab + Gemcitabine + Cisplatin   Gemcitabine + Cisplatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 545   548   1093 
Age 
[Units: Years]
Median (Full Range)
 62.0 
 (32 to 84) 
 62.0 
 (32 to 86) 
 62.0 
 (32 to 86) 
Gender 
[Units: Participants]
     
Female   95   90   185 
Male   450   458   908 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   55   56   111 
Not Hispanic or Latino   489   490   979 
Unknown or Not Reported   1   2   3 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   43   42   85 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   5   6   11 
White   457   456   913 
More than one race   1   0   1 
Other   38   43   81 
Region of Enrollment 
[Units: Participants]
     
Russian Federation   94   101   195 
Singapore   1   2   3 
United States   20   16   36 
Thailand   3   6   9 
Portugal   8   9   17 
Greece   18   14   32 
Austria   4   4   8 
Brazil   28   30   58 
Korea, Republic of   24   23   47 
Poland   69   59   128 
Slovakia   9   10   19 
France   34   39   73 
Serbia   11   13   24 
Croatia   2   4   6 
Romania   46   45   91 
Hungary   43   41   84 
Philippines   12   8   20 
United Kingdom   9   10   19 
Spain   33   25   58 
Canada   2   4   6 
Belgium   4   4   8 
Taiwan   3   2   5 
Italy   13   12   25 
South Africa   2   2   4 
Australia   4   6   10 
Germany   49   59   108 
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline [1] 
[Units: Participants]
     
 164   180   344 
 332   320   652 
 49   47   96 
 0   1   1 
[1] ECOG classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 1 participant with ECOG PS 3 was randomized to the Gemcitabine + Cisplatin arm but did not receive treatment.
Smoking History 
[Units: Participants]
     
Ex-Light Smoker   18   26   44 
Non-Smoker   26   27   53 
Smoker   500   495   995 
Missing   1   0   1 
Disease Stage at Study Entry [1] 
[Units: Participants]
     
Stage IIIB   1   1   2 
Stage IV   543   546   1089 
Missing   1   1   2 
[1] Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIB - the cancer has spread to nearby tissue or spread to far away lymph nodes. Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver.
Disease Histology 
[Units: Participants]
     
Squamous   543   545   1088 
Other Histology   2   3   5 
Sites of Metastatic Disease [1] 
[Units: Participants]
     
Bone   120   131   251 
Brain   28   30   58 
Liver   109   117   226 
Lung   453   453   906 
Lymph Nodes   431   451   882 
Peritoneal   20   17   37 
Pleural   149   155   304 
Skin   9   8   17 
Soft Tissue   23   21   44 
Other   156   146   302 
[1] Participants may record multiple sites of metastatic disease.


  Outcome Measures
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1.  Primary:   Overall Survival Time (OS)   [ Time Frame: Randomization to Death from Any Cause (Up to 31 Months) ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months) ]

3.  Secondary:   Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])   [ Time Frame: Baseline to Measured Progressive Disease (Up to 31 Months) ]

4.  Secondary:   Time to Treatment Failure (TTF)   [ Time Frame: Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months) ]

5.  Secondary:   Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)   [ Time Frame: Baseline, Cycle 6 (Cycle = 3 Weeks) ]

6.  Secondary:   Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)   [ Time Frame: Baseline, Cycle 6 (Cycle = 3 Weeks) ]

7.  Secondary:   Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)   [ Time Frame: 31 Months ]

8.  Secondary:   Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab   [ Time Frame: Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months ]

9.  Secondary:   Number of Participants With a Serum Anti-Necitumumab Antibody Assessment   [ Time Frame: Baseline through 31 Months ]


  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
No text entered.


  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 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


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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00981058     History of Changes
Other Study ID Numbers: 13909
CP11-0806 ( Other Identifier: ImClone Systems )
I4X-IE-JFCC ( Other Identifier: Eli Lilly and Company )
2009-013838-25 ( EudraCT Number )
Study First Received: September 18, 2009
Results First Received: December 21, 2015
Last Updated: September 12, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Croatia: Ministry of Health and Social Care
France: ANSM - French Health Products Safety Agency
Germany: Paul-Ehrlich-Institut
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Thailand: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration