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

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: NCT00981058
Recruitment Status : Active, not recruiting
First Posted : September 22, 2009
Results First Posted : June 27, 2016
Last Update Posted : August 1, 2018
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Small Cell Lung Cancer
Interventions Biological: Necitumumab
Drug: Gemcitabine
Drug: Cisplatin
Enrollment 1093
Recruitment Details  
Pre-assignment Details Participants who completed the study include those who died due to any cause or were alive and on study at conclusion, but off treatment.
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Hide Arm/Group Description

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: 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.

Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin Total
Hide Arm/Group Description

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: 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 of all reporting groups
Overall Number of Baseline Participants 545 548 1093
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 545 participants 548 participants 1093 participants
62.0
(32 to 84)
62.0
(32 to 86)
62.0
(32 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 545 participants 548 participants 1093 participants
Female
95
  17.4%
90
  16.4%
185
  16.9%
Male
450
  82.6%
458
  83.6%
908
  83.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 545 participants 548 participants 1093 participants
Hispanic or Latino
55
  10.1%
56
  10.2%
111
  10.2%
Not Hispanic or Latino
489
  89.7%
490
  89.4%
979
  89.6%
Unknown or Not Reported
1
   0.2%
2
   0.4%
3
   0.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 545 participants 548 participants 1093 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 545 participants 548 participants 1093 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 545 participants 548 participants 1093 participants
0 164 180 344
1 332 320 652
2 49 47 96
3 0 1 1
[1]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 545 participants 548 participants 1093 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 545 participants 548 participants 1093 participants
Stage IIIB 1 1 2
Stage IV 543 546 1089
Missing 1 1 2
[1]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 545 participants 548 participants 1093 participants
Squamous 543 545 1088
Other Histology 2 3 5
Sites of Metastatic Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 545 participants 548 participants 1093 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]
Measure Description: Participants may record multiple sites of metastatic disease.
1.Primary Outcome
Title Overall Survival Time (OS)
Hide Description Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method.
Time Frame Randomization to Death from Any Cause (Up to 31 Months)
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Hide Analysis Population Description
All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 127, Gemcitabine + Cisplatin = 106
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Hide Arm/Group Description:

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: 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.

Overall Number of Participants Analyzed 545 548
Median (95% Confidence Interval)
Unit of Measure: Months
11.5
(10.4 to 12.6)
9.9
(8.9 to 11.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Necitumumab + Gemcitabine + Cisplatin, Gemcitabine + Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0120
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.842
Confidence Interval (2-Sided) 95%
0.736 to 0.962
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.
Time Frame Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 114, Gemcitabine + Cisplatin = 131
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Hide Arm/Group Description:

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: 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.

Overall Number of Participants Analyzed 545 548
Median (95% Confidence Interval)
Unit of Measure: months
5.7
(5.6 to 6.0)
5.5
(4.8 to 5.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Necitumumab + Gemcitabine + Cisplatin, Gemcitabine + Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0201
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.851
Confidence Interval (2-Sided) 95%
0.743 to 0.975
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])
Hide Description ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions. PR defined as a >=30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.
Time Frame Baseline to Measured Progressive Disease (Up to 31 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Hide Arm/Group Description:

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: 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.

Overall Number of Participants Analyzed 545 548
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.2
(27.4 to 35.2)
28.8
(25.2 to 32.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Necitumumab + Gemcitabine + Cisplatin, Gemcitabine + Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3997
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.86 to 1.45
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Treatment Failure (TTF)
Hide Description TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death from any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.
Time Frame Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 16, Gemcitabine + Cisplatin =20
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Hide Arm/Group Description:

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: 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.

Overall Number of Participants Analyzed 545 548
Median (95% Confidence Interval)
Unit of Measure: Months
4.3
(4.2 to 4.8)
3.6
(3.3 to 4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Necitumumab + Gemcitabine + Cisplatin, Gemcitabine + Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0061
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.844
Confidence Interval (2-Sided) 95%
0.747 to 0.953
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)
Hide Description The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
Time Frame Baseline, Cycle 6 (Cycle = 3 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had evaluable baseline and postbaseline EQ-5D data.
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Hide Arm/Group Description:

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: 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.

Overall Number of Participants Analyzed 305 245
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.0053  (0.23626) -0.0083  (0.23866)
6.Secondary Outcome
Title Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)
Hide Description The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.
Time Frame Baseline, Cycle 6 (Cycle = 3 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had evaluable data for LCSS.
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Hide Arm/Group Description:

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: 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.

Overall Number of Participants Analyzed 545 548
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
Loss of Appetite (n=304, 242) 1.8  (31.84) 1.5  (29.30)
Fatigue (n=302, 242) 6.3  (29.15) 3.5  (25.29)
Cough (n=303, 243) -7.8  (28.05) -9.1  (25.74)
Dyspnea (n=305, 244) -2.8  (26.52) -1.8  (25.27)
Pain (n=302, 243) -3.3  (17.98) -2.2  (17.22)
Overall Symptoms (n=303, 242) -0.3  (26.19) -0.6  (26.92)
Interference (n=306,241) 3.8  (29.74) 2.2  (26.79)
Quality of Life (n=305, 243) -0.3  (27.35) -1.6  (24.71)
Average Symptom Burden Index (ASBI) (n=294, 234) -1.9  (16.55) -1.5  (16.52)
LCSS Total Score (n=290, 228) -0.8  (17.03) -0.8  (16.17)
7.Secondary Outcome
Title Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
Hide Description EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of <200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.
Time Frame 31 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable data for EGFR IHC.
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Hide Arm/Group Description:

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: 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.

Overall Number of Participants Analyzed 486 496
Measure Type: Number
Unit of Measure: participants
0 24 23
>0 462 473
<200 295 313
≥200 191 183
8.Secondary Outcome
Title Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Hide Description [Not Specified]
Time Frame Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable data for PK.
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 545
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms/milliliter (ug/mL)
Predose Cycle 2 Day 1 (n=419)
52.4
(95.9%)
Predose Cycle3 Day 1 (n=386)
76.6
(80.6%)
Predose Cycle 4 Day 1 (n=344)
94.5
(92.2%)
Predose Cycle 5 Day 1 (n=297)
101
(90%)
Predose Cycle 6 Day 1 (n=262)
98.5
(80%)
9.Secondary Outcome
Title Number of Participants With a Serum Anti-Necitumumab Antibody Assessment
Hide Description A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.
Time Frame Baseline through 31 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received who received at least 1 dose of drug and had evaluable data for antibodies.
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 528
Measure Type: Number
Unit of Measure: participants
Participants with at least 1 positive titer 81
Neutralizing antibody detected 5
Time Frame [Not Specified]
Adverse Event Reporting Description All participants who received at least 1 dose of study drug.
 
Arm/Group Title Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Hide Arm/Group Description

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: 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.

All-Cause Mortality
Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   262/538 (48.70%)      208/541 (38.45%)    
Blood and lymphatic system disorders     
Agranulocytosis  1  1/538 (0.19%)  4 0/541 (0.00%)  0
Anaemia  1  22/538 (4.09%)  25 17/541 (3.14%)  20
Bone marrow failure  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Febrile neutropenia  1  6/538 (1.12%)  6 7/541 (1.29%)  7
Leukopenia  1  6/538 (1.12%)  6 4/541 (0.74%)  6
Neutropenia  1  20/538 (3.72%)  24 33/541 (6.10%)  40
Pancytopenia  1  6/538 (1.12%)  6 3/541 (0.55%)  4
Thrombocytopenia  1  17/538 (3.16%)  28 20/541 (3.70%)  26
Thrombocytosis  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Acute myocardial infarction  1  2/538 (0.37%)  2 1/541 (0.18%)  1
Atrial fibrillation  1  3/538 (0.56%)  7 4/541 (0.74%)  6
Atrial flutter  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Cardiac arrest  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Cardiac failure  1  0/538 (0.00%)  0 2/541 (0.37%)  2
Cardiac failure acute  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Cardiac failure congestive  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Cardiac tamponade  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Cardio-respiratory arrest  1  3/538 (0.56%)  3 1/541 (0.18%)  1
Coronary artery disease  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Myocardial infarction  1  2/538 (0.37%)  2 2/541 (0.37%)  2
Myocardial ischaemia  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Pericardial effusion  1  0/538 (0.00%)  0 1/541 (0.18%)  2
Pericarditis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Supraventricular tachycardia  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Congenital, familial and genetic disorders     
Tracheo-oesophageal fistula  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Ear and labyrinth disorders     
Deafness bilateral  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Ototoxicity  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  2/538 (0.37%)  3 1/541 (0.18%)  1
Abdominal pain upper  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Colitis ischaemic  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Constipation  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Diarrhoea  1  8/538 (1.49%)  8 5/541 (0.92%)  5
Duodenal ulcer  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Duodenal ulcer perforation  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Dysphagia  1  3/538 (0.56%)  3 1/541 (0.18%)  1
Enteritis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Gastric haemorrhage  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Gastric ulcer  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Gastroduodenal ulcer  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Gastrointestinal disorder  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Haematemesis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Haematochezia  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Ileus  1  0/538 (0.00%)  0 1/541 (0.18%)  2
Intestinal obstruction  1  1/538 (0.19%)  1 2/541 (0.37%)  2
Mesenteric vein thrombosis  1  1/538 (0.19%)  1 1/541 (0.18%)  2
Nausea  1  4/538 (0.74%)  4 2/541 (0.37%)  3
Pancreatitis acute  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Small intestinal obstruction  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Stomatitis  1  2/538 (0.37%)  2 3/541 (0.55%)  3
Upper gastrointestinal haemorrhage  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Vomiting  1  12/538 (2.23%)  13 2/541 (0.37%)  2
General disorders     
Asthenia  1  2/538 (0.37%)  2 3/541 (0.55%)  3
Chills  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Death  1  8/538 (1.49%)  8 3/541 (0.55%)  3
Fatigue  1  3/538 (0.56%)  3 4/541 (0.74%)  4
General physical health deterioration  1  8/538 (1.49%)  9 7/541 (1.29%)  7
Generalised oedema  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Non-cardiac chest pain  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Oedema  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Oedema peripheral  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Pyrexia  1  7/538 (1.30%)  8 4/541 (0.74%)  4
Sudden death  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Hepatobiliary disorders     
Bile duct stenosis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Cholelithiasis  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Hepatorenal syndrome  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Immune system disorders     
Drug hypersensitivity  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Infections and infestations     
Appendicitis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Bacterial infection  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Bronchitis  1  6/538 (1.12%)  6 3/541 (0.55%)  3
Cystitis  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Dental gangrene  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Device related infection  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Escherichia urinary tract infection  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Gastroenteritis  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Infectious pleural effusion  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Injection site abscess  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Lower respiratory tract infection  1  4/538 (0.74%)  5 4/541 (0.74%)  4
Lung infection  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Neutropenic sepsis  1  0/538 (0.00%)  0 2/541 (0.37%)  2
Oral fungal infection  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Pneumonia  1  12/538 (2.23%)  12 20/541 (3.70%)  23
Pneumonia bacterial  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Pneumonia necrotising  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Pulmonary tuberculosis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Pyelonephritis acute  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Respiratory tract infection  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Respiratory tract infection bacterial  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Sepsis  1  2/538 (0.37%)  2 5/541 (0.92%)  5
Septic shock  1  0/538 (0.00%)  0 3/541 (0.55%)  3
Upper respiratory tract infection  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Upper respiratory tract infection bacterial  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Urinary tract infection  1  2/538 (0.37%)  2 1/541 (0.18%)  1
Urosepsis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Injury, poisoning and procedural complications     
Femoral neck fracture  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Femur fracture  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Head injury  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Incorrect dose administered  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Medication error  1  12/538 (2.23%)  16 21/541 (3.88%)  27
Overdose  1  1/538 (0.19%)  2 0/541 (0.00%)  0
Spinal compression fracture  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Toxicity to various agents  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Underdose  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Vascular graft occlusion  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Aspartate aminotransferase increased  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Blood creatinine increased  1  6/538 (1.12%)  6 1/541 (0.18%)  1
Blood phosphorus decreased  1  1/538 (0.19%)  1 0/541 (0.00%)  0
C-reactive protein increased  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Ecg signs of myocardial ischaemia  1  0/538 (0.00%)  0 1/541 (0.18%)  1
False positive investigation result  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Gamma-glutamyltransferase increased  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Haemoglobin decreased  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Platelet count decreased  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Dehydration  1  5/538 (0.93%)  7 8/541 (1.48%)  8
Diabetic ketoacidosis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Electrolyte imbalance  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Hypercalcaemia  1  3/538 (0.56%)  3 2/541 (0.37%)  2
Hypercreatininaemia  1  0/538 (0.00%)  0 1/541 (0.18%)  4
Hyperglycaemia  1  1/538 (0.19%)  1 3/541 (0.55%)  4
Hyperkalaemia  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Hyperuricaemia  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Hypocalcaemia  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Hypokalaemia  1  3/538 (0.56%)  3 2/541 (0.37%)  2
Hypomagnesaemia  1  3/538 (0.56%)  4 1/541 (0.18%)  1
Hyponatraemia  1  4/538 (0.74%)  4 6/541 (1.11%)  13
Hypophosphataemia  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  5/538 (0.93%)  6 1/541 (0.18%)  1
Intervertebral disc protrusion  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Musculoskeletal pain  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Osteolysis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Pain in extremity  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Pathological fracture  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Metastases to bone  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Metastases to central nervous system  1  1/538 (0.19%)  1 2/541 (0.37%)  3
Metastatic pain  1  0/538 (0.00%)  0 2/541 (0.37%)  2
Non-small cell lung cancer  1  26/538 (4.83%)  27 23/541 (4.25%)  23
Pericardial effusion malignant  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Nervous system disorders     
Ataxia  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Brain oedema  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Cerebral haemorrhage  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Cerebral infarction  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Cerebral ischaemia  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Convulsion  1  3/538 (0.56%)  3 0/541 (0.00%)  0
Dizziness  1  4/538 (0.74%)  4 0/541 (0.00%)  0
Encephalopathy  1  0/538 (0.00%)  0 2/541 (0.37%)  3
Epilepsy  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Headache  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Hemiplegia  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Hydrocephalus  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Ischaemic stroke  1  4/538 (0.74%)  4 0/541 (0.00%)  0
Loss of consciousness  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Nerve root compression  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Paraesthesia  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Peripheral motor neuropathy  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Presyncope  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Radial nerve palsy  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Sciatica  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Spinal cord compression  1  1/538 (0.19%)  1 1/541 (0.18%)  2
Syncope  1  4/538 (0.74%)  4 3/541 (0.55%)  3
Transient ischaemic attack  1  2/538 (0.37%)  2 1/541 (0.18%)  1
Vocal cord paralysis  1  0/538 (0.00%)  0 2/541 (0.37%)  2
Psychiatric disorders     
Abnormal behaviour  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Alcohol abuse  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Completed suicide  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Confusional state  1  2/538 (0.37%)  3 1/541 (0.18%)  1
Delirium  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Depression  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Renal and urinary disorders     
Nephropathy toxic  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Nephrotic syndrome  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Renal failure  1  8/538 (1.49%)  8 6/541 (1.11%)  11
Renal failure acute  1  4/538 (0.74%)  4 5/541 (0.92%)  5
Renal infarct  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Renal tubular necrosis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Urinary retention  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Reproductive system and breast disorders     
Pelvic pain  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Acute respiratory distress syndrome  1  0/538 (0.00%)  0 1/541 (0.18%)  2
Acute respiratory failure  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Bronchitis chronic  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Chronic obstructive pulmonary disease  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Cough  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Dyspnoea  1  3/538 (0.56%)  3 4/541 (0.74%)  5
Epistaxis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Haemoptysis  1  11/538 (2.04%)  15 9/541 (1.66%)  9
Interstitial lung disease  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Lung infiltration  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Pharyngeal inflammation  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Pleural effusion  1  4/538 (0.74%)  4 1/541 (0.18%)  1
Pneumonitis  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Pneumothorax  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Pulmonary artery thrombosis  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Pulmonary embolism  1  19/538 (3.53%)  20 9/541 (1.66%)  9
Pulmonary haemorrhage  1  1/538 (0.19%)  1 5/541 (0.92%)  5
Pulmonary hypertension  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Pulmonary oedema  1  1/538 (0.19%)  1 1/541 (0.18%)  2
Pulmonary toxicity  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Pulmonary venous thrombosis  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Respiratory failure  1  2/538 (0.37%)  2 2/541 (0.37%)  2
Respiratory tract haemorrhage  1  0/538 (0.00%)  0 2/541 (0.37%)  2
Skin and subcutaneous tissue disorders     
Dermatitis acneiform  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Dermatitis allergic  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Rash maculo-papular  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Skin fissures  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Skin toxicity  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Skin ulcer  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Social circumstances     
Social stay hospitalisation  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  4/538 (0.74%)  4 1/541 (0.18%)  1
Femoral artery occlusion  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Hypertensive crisis  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Hypotension  1  2/538 (0.37%)  2 0/541 (0.00%)  0
Hypovolaemic shock  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Orthostatic hypotension  1  0/538 (0.00%)  0 2/541 (0.37%)  2
Peripheral arterial occlusive disease  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Peripheral artery thrombosis  1  2/538 (0.37%)  2 1/541 (0.18%)  1
Peripheral embolism  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Superior vena cava syndrome  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Thrombophlebitis superficial  1  0/538 (0.00%)  0 1/541 (0.18%)  1
Thrombosis  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Vena cava thrombosis  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Venous insufficiency  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Venous thrombosis  1  1/538 (0.19%)  1 1/541 (0.18%)  1
Venous thrombosis limb  1  1/538 (0.19%)  1 0/541 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Necitumumab + Gemcitabine + Cisplatin Gemcitabine + Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   516/538 (95.91%)      506/541 (93.53%)    
Blood and lymphatic system disorders     
Anaemia  1  218/538 (40.52%)  519 241/541 (44.55%)  519
Leukopenia  1  71/538 (13.20%)  122 85/541 (15.71%)  168
Neutropenia  1  220/538 (40.89%)  512 229/541 (42.33%)  555
Thrombocytopenia  1  103/538 (19.14%)  224 124/541 (22.92%)  244
Gastrointestinal disorders     
Abdominal pain upper  1  31/538 (5.76%)  35 28/541 (5.18%)  38
Constipation  1  110/538 (20.45%)  156 98/541 (18.11%)  122
Diarrhoea  1  81/538 (15.06%)  123 58/541 (10.72%)  70
Dyspepsia  1  27/538 (5.02%)  40 22/541 (4.07%)  29
Nausea  1  265/538 (49.26%)  587 283/541 (52.31%)  616
Stomatitis  1  57/538 (10.59%)  79 32/541 (5.91%)  35
Vomiting  1  152/538 (28.25%)  281 134/541 (24.77%)  202
General disorders     
Asthenia  1  123/538 (22.86%)  257 111/541 (20.52%)  196
Fatigue  1  114/538 (21.19%)  200 121/541 (22.37%)  225
Oedema peripheral  1  42/538 (7.81%)  54 41/541 (7.58%)  51
Pyrexia  1  68/538 (12.64%)  83 58/541 (10.72%)  75
Infections and infestations     
Paronychia  1  36/538 (6.69%)  58 1/541 (0.18%)  1
Urinary tract infection  1  27/538 (5.02%)  38 9/541 (1.66%)  11
Investigations     
Blood creatinine increased  1  48/538 (8.92%)  86 40/541 (7.39%)  67
Weight decreased  1  72/538 (13.38%)  95 34/541 (6.28%)  43
Metabolism and nutrition disorders     
Decreased appetite  1  158/538 (29.37%)  234 151/541 (27.91%)  251
Hyperglycaemia  1  27/538 (5.02%)  48 15/541 (2.77%)  26
Hypokalaemia  1  37/538 (6.88%)  54 26/541 (4.81%)  42
Hypomagnesaemia  1  159/538 (29.55%)  490 81/541 (14.97%)  139
Hyponatraemia  1  23/538 (4.28%)  34 28/541 (5.18%)  41
Musculoskeletal and connective tissue disorders     
Back pain  1  36/538 (6.69%)  48 27/541 (4.99%)  30
Nervous system disorders     
Dizziness  1  55/538 (10.22%)  65 42/541 (7.76%)  46
Dysgeusia  1  33/538 (6.13%)  36 18/541 (3.33%)  20
Headache  1  56/538 (10.41%)  72 31/541 (5.73%)  42
Psychiatric disorders     
Insomnia  1  28/538 (5.20%)  33 27/541 (4.99%)  34
Respiratory, thoracic and mediastinal disorders     
Cough  1  87/538 (16.17%)  126 68/541 (12.57%)  83
Dyspnoea  1  86/538 (15.99%)  119 77/541 (14.23%)  100
Epistaxis  1  40/538 (7.43%)  46 16/541 (2.96%)  20
Haemoptysis  1  45/538 (8.36%)  58 20/541 (3.70%)  22
Productive cough  1  27/538 (5.02%)  35 12/541 (2.22%)  14
Skin and subcutaneous tissue disorders     
Acne  1  47/538 (8.74%)  79 3/541 (0.55%)  3
Alopecia  1  76/538 (14.13%)  87 70/541 (12.94%)  72
Dermatitis acneiform  1  80/538 (14.87%)  145 3/541 (0.55%)  4
Dry skin  1  35/538 (6.51%)  41 8/541 (1.48%)  8
Pruritus  1  38/538 (7.06%)  50 5/541 (0.92%)  5
Rash  1  235/538 (43.68%)  487 30/541 (5.55%)  36
Rash generalised  1  28/538 (5.20%)  65 2/541 (0.37%)  2
Skin fissures  1  27/538 (5.02%)  47 0/541 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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.
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 )
First Submitted: September 18, 2009
First Posted: September 22, 2009
Results First Submitted: December 21, 2015
Results First Posted: June 27, 2016
Last Update Posted: August 1, 2018