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: May 20, 2016
Last verified: May 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  
Number of Participants  
[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]
     
0     164     180     344  
1     332     320     652  
2     49     47     96  
3     0     1     1  
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 [2]
[units: participants]
     
Stage IIIB     1     1     2  
Stage IV     543     546     1089  
Missing     1     1     2  
Disease Histology  
[units: participants]
     
Squamous     543     545     1088  
Other Histology     2     3     5  
Sites of Metastatic Disease [3]
[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] 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.
[2] 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.
[3] 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
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  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: May 20, 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