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First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin (INSPIRE)

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ClinicalTrials.gov Identifier: NCT00982111
Recruitment Status : Suspended
First Posted : September 22, 2009
Results First Posted : June 27, 2016
Last Update Posted : November 28, 2018
Sponsor:
Collaborators:
Quintiles, Inc.
Parexel
PPD
Medidata Solutions
Laboratory Corporation of America
University of Colorado, Denver
Thermo Fisher Scientific
Pacific Biomarkers
Intertek
Sysmex Inostics GmbH
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 Drug: Pemetrexed
Drug: Cisplatin
Biological: Necitumumab
Enrollment 633
Recruitment Details  
Pre-assignment Details Completers included participants who died from any cause and participants who were alive and on study at conclusion however were off treatment.
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Hide Arm/Group Description

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 milligrams (mg) (absolute dose) on Days 1 and 8 of every 3-week cycle.

Pemetrexed: 500 mg/square meter (mg/m2) intravenous (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles.

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.

Pemetrexed + Cisplatin

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.

Period Title: Overall Study
Started 315 318
Received at Least 1 Dose of Study Drug 304 312
Death Due to Any Cause 236 246
On Study at Conclusion, Off Treatment 4 6
Completed 240 252
Not Completed 75 66
Reason Not Completed
Adverse Event             1             1
Progressive Disease             37             37
Lost to Follow-up             9             6
New Anti-Cancer Therapy             5             5
On Study Treatment at Conclusion             7             0
Withdrawal by Subject             16             17
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin Total
Hide Arm/Group Description

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Pemetrexed + Cisplatin

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Total of all reporting groups
Overall Number of Baseline Participants 315 318 633
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 315 participants 318 participants 633 participants
61.0
(26 to 84)
60.0
(34 to 88)
61.00
(26 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 315 participants 318 participants 633 participants
Female
101
  32.1%
108
  34.0%
209
  33.0%
Male
214
  67.9%
210
  66.0%
424
  67.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 315 participants 318 participants 633 participants
Hispanic or Latino
47
  14.9%
46
  14.5%
93
  14.7%
Not Hispanic or Latino
268
  85.1%
272
  85.5%
540
  85.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 315 participants 318 participants 633 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   0.6%
0
   0.0%
2
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
   2.5%
9
   2.8%
17
   2.7%
White
292
  92.7%
298
  93.7%
590
  93.2%
More than one race
13
   4.1%
11
   3.5%
24
   3.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 315 participants 318 participants 633 participants
Russian Federation 16 13 29
Romania 21 31 52
Hungary 23 22 45
United States 0 1 1
United Kingdom 11 11 22
Portugal 6 1 7
Spain 40 27 67
Greece 5 10 15
Canada 2 1 3
Austria 8 11 19
Belgium 8 9 17
Brazil 37 35 72
Poland 28 24 52
Italy 17 19 36
South Africa 2 5 7
Slovakia 3 1 4
Australia 6 8 14
France 7 3 10
Germany 75 84 159
Croatia 0 2 2
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 315 participants 318 participants 633 participants
0 115 132 247
1 183 166 349
2 16 20 36
Missing 1 0 1
[1]
Measure Description: Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 0 - Fully Active. 1 - Ambulatory, Restricted Strenuous Activity. 2 - Ambulatory, No Work Activities. 3 - Partially Confined to Bed, Limited Self Care. 4 - Completely Disabled. 5 - Death.
Smoking  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 315 participants 318 participants 633 participants
Ex-Light Smoker 26 27 53
Nonsmoker 51 53 104
Smoker 238 238 476
Disease Stage at Study Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 315 participants 318 participants 633 participants
Stage IIIB 9 11 20
Stage IV 305 307 612
Missing 1 0 1
[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 315 participants 318 participants 633 participants
Adenocarcinoma/Large Cell Carcinoma 307 311 618
Other 7 7 14
Missing 1 0 1
Sites of Metastatic Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 315 participants 318 participants 633 participants
Bone 103 109 212
Brain 27 25 52
Liver 58 64 122
Lung 259 268 527
Lymph Nodes 239 240 479
Peritoneal 21 22 43
Pleural 111 111 222
Skin 7 5 12
Soft Tissue 19 21 40
Other 87 93 180
[1]
Measure Description: Participants may record multiple sites of metastatic disease.
1.Primary Outcome
Title Overall Survival Time (OS)
Hide Description OS 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 using the Kaplan-Meier method.
Time Frame Randomization to Death from Any Cause (Up to 31.6 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin =79, Pemetrexed + Cisplatin=72
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Hide Arm/Group Description:

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Pemetrexed + Cisplatin

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Overall Number of Participants Analyzed 315 318
Median (95% Confidence Interval)
Unit of Measure: Months
11.3
(9.5 to 13.4)
11.5
(10.1 to 13.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Necitumumab + Pemetrexed + Cisplatin, Pemetrexed + Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9561
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.84 to 1.21
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 measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Participants who die without a reported prior progression will be 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 participant was 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 30.4 Months)
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Hide Analysis Population Description
All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin=84, Pemetrexed + Cisplatin=79
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Hide Arm/Group Description:

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Pemetrexed + Cisplatin

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Overall Number of Participants Analyzed 315 318
Median (95% Confidence Interval)
Unit of Measure: Months
5.6
(5.1 to 6.0)
5.6
(4.8 to 5.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Necitumumab + Pemetrexed + Cisplatin, Pemetrexed + Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6647
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.80 to 1.16
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Tumor 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 30.4 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Hide Arm/Group Description:

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Pemetrexed + Cisplatin

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Overall Number of Participants Analyzed 315 318
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.1
(26.3 to 36.4)
32.1
(27.2 to 37.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Necitumumab + Pemetrexed + Cisplatin, Pemetrexed + Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7945
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.68 to 1.34
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Treatment Failure (TTF)
Hide Description TTF was defined as the time from study enrollment/randomization to the first observation of measured progressive disease, death from any cause, or early discontinuation of treatment or initiation of new anti-cancer therapies. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of longest diameter of target lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.
Time Frame Randomization to Measured Progressive Disease, Death from Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 30.4 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin = 10, Pemetrexed + Cisplatin = 13
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Hide Arm/Group Description:

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Pemetrexed + Cisplatin

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Overall Number of Participants Analyzed 315 318
Median (95% Confidence Interval)
Unit of Measure: Months
3.5
(3.2 to 3.9)
4.3
(3.3 to 4.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Necitumumab + Pemetrexed + Cisplatin, Pemetrexed + Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0459
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
1.00 to 1.39
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Hide Description [Not Specified]
Time Frame Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized to necitumumab and had evaluable PK data.
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin
Hide Arm/Group Description:

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Overall Number of Participants Analyzed 315
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms/milliliter (ug/ml)
Predose Cycle 2 Day 1 (n=222)
57.5
(84.5%)
Predose Cycle 3 Day 1 (n=185)
80.8
(89.3%)
Predose Cycle 4 Day 1 (n=159)
110
(82.9%)
Predose Cycle 5 Day 1 (n=131)
115
(81.8%)
Predose Cycle 6 Day 1 (n=110)
119
(68.9%)
6.Secondary Outcome
Title Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)
Hide Description A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-Necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.
Time Frame Baseline to Study Completion (Up to 31.6 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of necitumumab and had evaluable antibody data.
Arm/Group Title Necitumumab + Pemextrexed + Cisplatin
Hide Arm/Group Description:

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Overall Number of Participants Analyzed 301
Measure Type: Number
Unit of Measure: participants
1 Positive Titer 37
Antibodies Detected 18
7.Secondary Outcome
Title Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had evaluable baseline and postbaseline EQ-5D data.
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Hide Arm/Group Description:

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Pemetrexed + Cisplatin

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Overall Number of Participants Analyzed 143 147
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.0419  (0.28230) 0.0478  (0.22645)
8.Secondary Outcome
Title Mean Change From Baseline in PRO as Measured Using the 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had evaluable baseline and postbaseline LCSS data.
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Hide Arm/Group Description:

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Pemetrexed + Cisplatin

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Overall Number of Participants Analyzed 315 318
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
Loss of Appetite (n=142,147) 4.6  (46.18) 0.6  (27.52)
Fatigue (n=142, 148) 4.5  (31.24) 1.6  (28.75)
Cough (n=143, 148) -9.1  (31.08) -10.3  (27.88)
Dyspnea (n=141,146) -2.8  (26.32) -1.5  (23.67)
Hemoptysis (n=141,147) -1.1  (11.92) -1.1  (7.81)
Pain (n=142, 147) -4.2  (27.22) -7.1  (26.64)
Overall Symptoms (n=141,146) -3.1  (31.22) -7.4  (27.11)
Quality of Life (n=142, 146) 2.5  (26.01) -3.3  (24.91)
Interference (n=141, 145) 3.2  (27.15) -4.0  (31.39)
Average Symptom Burden Index (ASBI) (n=133, 138) -0.9  (18.35) -3.1  (13.11)
LCSS Total Score (n=132, 132) 0.1  (17.59) -4.3  (13.90)
9.Secondary Outcome
Title Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
Hide Description EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses 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 Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment.
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Hide Arm/Group Description:

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Pemetrexed + Cisplatin

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Overall Number of Participants Analyzed 245 345
Mean (Standard Deviation)
Unit of Measure: H-Score
H-score <200 (n=144, 146) 69.06  (64.68) 66.23  (64.15)
H-score >=200 (n=101, 99) 259.35  (27.65) 256.26  (29.10)
10.Secondary Outcome
Title Percentage of Participants With EGFR Measured by IHC
Hide Description EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses 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 Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Hide Arm/Group Description:

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Pemetrexed + Cisplatin

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Overall Number of Participants Analyzed 245 245
Measure Type: Number
Unit of Measure: percentage of participants
H-score <200 (n=144,146) 58.8 59.6
H-score >=200 (n=101, 99) 41.2 40.4
Time Frame [Not Specified]
Adverse Event Reporting Description All participants who received at least 1 dose of study drug.
 
Arm/Group Title Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Hide Arm/Group Description

Necitumumab + Pemetrexed + Cisplatin

Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Pemetrexed + Cisplatin

Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

All-Cause Mortality
Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   158/304 (51.97%)      130/312 (41.67%)    
Blood and lymphatic system disorders     
Anaemia  1  12/304 (3.95%)  15 13/312 (4.17%)  18
Febrile neutropenia  1  1/304 (0.33%)  1 2/312 (0.64%)  2
Granulocytopenia  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Leukopenia  1  5/304 (1.64%)  5 8/312 (2.56%)  8
Neutropenia  1  9/304 (2.96%)  9 5/312 (1.60%)  5
Pancytopenia  1  1/304 (0.33%)  1 1/312 (0.32%)  1
Splenic infarction  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Thrombocytopenia  1  8/304 (2.63%)  9 5/312 (1.60%)  6
Cardiac disorders     
Acute myocardial infarction  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Angina pectoris  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Arrhythmia supraventricular  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Atrial fibrillation  1  2/304 (0.66%)  2 2/312 (0.64%)  2
Atrial flutter  1  2/304 (0.66%)  2 0/312 (0.00%)  0
Cardiac failure  1  2/304 (0.66%)  2 0/312 (0.00%)  0
Cardiac tamponade  1  2/304 (0.66%)  2 0/312 (0.00%)  0
Cardio-respiratory arrest  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Cardiomyopathy  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Cardiopulmonary failure  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Myocardial infarction  1  1/304 (0.33%)  2 1/312 (0.32%)  1
Pericardial effusion  1  3/304 (0.99%)  3 2/312 (0.64%)  2
Sinus tachycardia  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Tachycardia  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Ear and labyrinth disorders     
Vertigo  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Dental caries  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Diarrhoea  1  10/304 (3.29%)  11 5/312 (1.60%)  5
Duodenal ulcer  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Duodenal ulcer haemorrhage  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Dysphagia  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Enterocolitis  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Gastrointestinal disorder  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Ileus paralytic  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Inguinal hernia  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Intestinal infarction  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Intestinal perforation  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Intra-abdominal haemorrhage  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Large intestine perforation  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Nausea  1  8/304 (2.63%)  12 6/312 (1.92%)  6
Oesophageal ulcer  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Oesophagitis  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Pneumatosis intestinalis  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Rectal haemorrhage  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Stomatitis  1  1/304 (0.33%)  1 3/312 (0.96%)  4
Volvulus  1  1/304 (0.33%)  1 1/312 (0.32%)  1
Vomiting  1  9/304 (2.96%)  10 7/312 (2.24%)  7
General disorders     
Asthenia  1  8/304 (2.63%)  11 2/312 (0.64%)  3
Chest pain  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Death  1  3/304 (0.99%)  3 1/312 (0.32%)  1
Fatigue  1  8/304 (2.63%)  10 7/312 (2.24%)  7
General physical health deterioration  1  6/304 (1.97%)  7 4/312 (1.28%)  5
Mucosal inflammation  1  4/304 (1.32%)  4 0/312 (0.00%)  0
Multi-organ failure  1  2/304 (0.66%)  2 0/312 (0.00%)  0
Oedema peripheral  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Performance status decreased  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Pyrexia  1  4/304 (1.32%)  4 0/312 (0.00%)  0
Systemic inflammatory response syndrome  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Hepatobiliary disorders     
Biliary colic  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Cholecystitis  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Hepatic failure  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Infections and infestations     
Abscess limb  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Bronchitis  1  1/304 (0.33%)  1 2/312 (0.64%)  2
Device related infection  1  2/304 (0.66%)  2 0/312 (0.00%)  0
Diverticulitis  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Erysipelas  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Gastrointestinal infection  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Hepatitis b  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Herpes dermatitis  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Herpes oesophagitis  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Infection  1  2/304 (0.66%)  2 2/312 (0.64%)  2
Intestinal gangrene  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Lung infection  1  2/304 (0.66%)  2 1/312 (0.32%)  2
Neutropenic sepsis  1  3/304 (0.99%)  3 0/312 (0.00%)  0
Oral candidiasis  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Peritoneal infection  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Pneumonia  1  14/304 (4.61%)  14 6/312 (1.92%)  7
Pyelonephritis  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Respiratory tract infection  1  1/304 (0.33%)  1 3/312 (0.96%)  3
Sepsis  1  4/304 (1.32%)  4 0/312 (0.00%)  0
Septic shock  1  1/304 (0.33%)  1 1/312 (0.32%)  1
Skin bacterial infection  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Skin infection  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Staphylococcal infection  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Staphylococcal sepsis  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Urinary tract infection  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Injury, poisoning and procedural complications     
Drug administration error  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Femur fracture  1  1/304 (0.33%)  1 1/312 (0.32%)  1
Hip fracture  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Incorrect dose administered  1  2/304 (0.66%)  3 2/312 (0.64%)  2
Lumbar vertebral fracture  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Medication error  1  6/304 (1.97%)  6 2/312 (0.64%)  2
Procedural pain  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Suture rupture  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Investigations     
International normalised ratio increased  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Weight decreased  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  6/304 (1.97%)  6 3/312 (0.96%)  3
Cachexia  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Dehydration  1  4/304 (1.32%)  4 5/312 (1.60%)  8
Electrolyte imbalance  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Fluid retention  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Hyperglycaemia  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Hyperkalaemia  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Hyperuricaemia  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Hypocalcaemia  1  3/304 (0.99%)  4 0/312 (0.00%)  0
Hypokalaemia  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Hypomagnesaemia  1  3/304 (0.99%)  3 1/312 (0.32%)  1
Hyponatraemia  1  0/304 (0.00%)  0 2/312 (0.64%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/304 (0.33%)  1 2/312 (0.64%)  2
Back pain  1  2/304 (0.66%)  2 1/312 (0.32%)  1
Bone pain  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Flank pain  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Musculoskeletal chest pain  1  3/304 (0.99%)  3 0/312 (0.00%)  0
Musculoskeletal pain  1  0/304 (0.00%)  0 2/312 (0.64%)  2
Myalgia  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Pain in extremity  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Pathological fracture  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Malignant pleural effusion  1  1/304 (0.33%)  2 1/312 (0.32%)  1
Metastases to central nervous system  1  5/304 (1.64%)  5 0/312 (0.00%)  0
Metastatic pain  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Non-small cell lung cancer  1  24/304 (7.89%)  24 10/312 (3.21%)  10
Tumour pain  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Nervous system disorders     
Cerebral infarction  1  1/304 (0.33%)  1 2/312 (0.64%)  2
Cerebral ischaemia  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Cerebrovascular accident  1  1/304 (0.33%)  1 4/312 (1.28%)  5
Convulsion  1  5/304 (1.64%)  5 0/312 (0.00%)  0
Dizziness  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Dizziness postural  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Hemiparesis  1  0/304 (0.00%)  0 2/312 (0.64%)  2
Hypotonia  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Ischaemic stroke  1  2/304 (0.66%)  2 0/312 (0.00%)  0
Migraine  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Paraesthesia  1  1/304 (0.33%)  1 1/312 (0.32%)  1
Spinal cord compression  1  0/304 (0.00%)  0 2/312 (0.64%)  2
Syncope  1  3/304 (0.99%)  3 0/312 (0.00%)  0
Psychiatric disorders     
Agitation  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Confusional state  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Depression  1  0/304 (0.00%)  0 1/312 (0.32%)  2
Renal and urinary disorders     
Nephropathy toxic  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Renal failure  1  4/304 (1.32%)  5 6/312 (1.92%)  7
Renal failure acute  1  3/304 (0.99%)  3 1/312 (0.32%)  1
Renal impairment  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/304 (0.33%)  1 1/312 (0.32%)  1
Acute respiratory distress syndrome  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Acute respiratory failure  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/304 (0.33%)  1 1/312 (0.32%)  1
Cough  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Dyspnoea  1  8/304 (2.63%)  8 5/312 (1.60%)  8
Epistaxis  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Haemoptysis  1  1/304 (0.33%)  1 1/312 (0.32%)  1
Interstitial lung disease  1  0/304 (0.00%)  0 1/312 (0.32%)  2
Pleural effusion  1  1/304 (0.33%)  2 3/312 (0.96%)  3
Pneumonitis  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Pneumothorax  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Pulmonary artery thrombosis  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Pulmonary embolism  1  13/304 (4.28%)  13 11/312 (3.53%)  11
Pulmonary haemorrhage  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Pulmonary oedema  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Respiratory failure  1  5/304 (1.64%)  5 2/312 (0.64%)  2
Skin and subcutaneous tissue disorders     
Rash  1  5/304 (1.64%)  5 0/312 (0.00%)  0
Rash maculo-papular  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Toxic skin eruption  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Urticaria  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Surgical and medical procedures     
Analgesic therapy  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Vascular disorders     
Aortic aneurysm rupture  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Arterial stenosis limb  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Arterial thrombosis limb  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Circulatory collapse  1  0/304 (0.00%)  0 2/312 (0.64%)  2
Deep vein thrombosis  1  5/304 (1.64%)  5 1/312 (0.32%)  1
Embolism  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Hypertension  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Orthostatic hypotension  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Peripheral embolism  1  2/304 (0.66%)  2 0/312 (0.00%)  0
Peripheral ischaemia  1  2/304 (0.66%)  2 0/312 (0.00%)  0
Poor venous access  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Subclavian vein thrombosis  1  2/304 (0.66%)  2 0/312 (0.00%)  0
Superior vena caval occlusion  1  0/304 (0.00%)  0 1/312 (0.32%)  1
Thrombosis  1  1/304 (0.33%)  1 1/312 (0.32%)  1
Venous thrombosis limb  1  1/304 (0.33%)  1 0/312 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Necitumumab + Pemetrexed + Cisplatin Pemetrexed + Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   292/304 (96.05%)      299/312 (95.83%)    
Blood and lymphatic system disorders     
Anaemia  1  71/304 (23.36%)  154 91/312 (29.17%)  200
Leukopenia  1  45/304 (14.80%)  91 36/312 (11.54%)  61
Lymphopenia  1  16/304 (5.26%)  53 17/312 (5.45%)  26
Neutropenia  1  92/304 (30.26%)  178 99/312 (31.73%)  217
Thrombocytopenia  1  22/304 (7.24%)  43 23/312 (7.37%)  42
Ear and labyrinth disorders     
Tinnitus  1  15/304 (4.93%)  18 16/312 (5.13%)  18
Eye disorders     
Conjunctivitis  1  31/304 (10.20%)  46 6/312 (1.92%)  6
Lacrimation increased  1  4/304 (1.32%)  4 17/312 (5.45%)  17
Gastrointestinal disorders     
Abdominal pain  1  18/304 (5.92%)  24 15/312 (4.81%)  15
Abdominal pain upper  1  26/304 (8.55%)  36 25/312 (8.01%)  29
Constipation  1  91/304 (29.93%)  132 83/312 (26.60%)  124
Diarrhoea  1  89/304 (29.28%)  147 51/312 (16.35%)  78
Dyspepsia  1  16/304 (5.26%)  21 18/312 (5.77%)  28
Nausea  1  174/304 (57.24%)  392 183/312 (58.65%)  403
Stomatitis  1  30/304 (9.87%)  41 12/312 (3.85%)  22
Vomiting  1  105/304 (34.54%)  213 104/312 (33.33%)  180
General disorders     
Asthenia  1  88/304 (28.95%)  192 68/312 (21.79%)  146
Fatigue  1  86/304 (28.29%)  163 95/312 (30.45%)  171
Mucosal inflammation  1  50/304 (16.45%)  104 27/312 (8.65%)  36
Non-cardiac chest pain  1  11/304 (3.62%)  16 16/312 (5.13%)  22
Oedema peripheral  1  40/304 (13.16%)  52 41/312 (13.14%)  51
Pyrexia  1  46/304 (15.13%)  57 22/312 (7.05%)  32
Infections and infestations     
Oral candidiasis  1  18/304 (5.92%)  22 5/312 (1.60%)  5
Paronychia  1  28/304 (9.21%)  64 0/312 (0.00%)  0
Urinary tract infection  1  19/304 (6.25%)  21 16/312 (5.13%)  21
Investigations     
Blood creatinine increased  1  21/304 (6.91%)  34 18/312 (5.77%)  23
Weight decreased  1  39/304 (12.83%)  53 24/312 (7.69%)  28
Metabolism and nutrition disorders     
Anorexia  1  110/304 (36.18%)  174 97/312 (31.09%)  171
Fluid retention  1  17/304 (5.59%)  39 12/312 (3.85%)  22
Hyperglycaemia  1  16/304 (5.26%)  34 10/312 (3.21%)  15
Hypocalcaemia  1  30/304 (9.87%)  51 13/312 (4.17%)  16
Hypokalaemia  1  20/304 (6.58%)  34 23/312 (7.37%)  33
Hypomagnesaemia  1  75/304 (24.67%)  185 36/312 (11.54%)  66
Hyponatraemia  1  23/304 (7.57%)  36 20/312 (6.41%)  30
Musculoskeletal and connective tissue disorders     
Back pain  1  33/304 (10.86%)  39 20/312 (6.41%)  24
Musculoskeletal pain  1  19/304 (6.25%)  26 15/312 (4.81%)  21
Pain in extremity  1  17/304 (5.59%)  21 17/312 (5.45%)  19
Nervous system disorders     
Dizziness  1  38/304 (12.50%)  50 26/312 (8.33%)  37
Dysgeusia  1  21/304 (6.91%)  27 32/312 (10.26%)  43
Headache  1  30/304 (9.87%)  41 27/312 (8.65%)  32
Paraesthesia  1  16/304 (5.26%)  20 8/312 (2.56%)  9
Psychiatric disorders     
Depression  1  18/304 (5.92%)  20 10/312 (3.21%)  11
Insomnia  1  17/304 (5.59%)  23 15/312 (4.81%)  20
Respiratory, thoracic and mediastinal disorders     
Cough  1  56/304 (18.42%)  74 48/312 (15.38%)  59
Dyspnoea  1  46/304 (15.13%)  62 41/312 (13.14%)  52
Epistaxis  1  21/304 (6.91%)  30 9/312 (2.88%)  9
Haemoptysis  1  21/304 (6.91%)  30 10/312 (3.21%)  12
Productive cough  1  16/304 (5.26%)  17 7/312 (2.24%)  9
Skin and subcutaneous tissue disorders     
Alopecia  1  29/304 (9.54%)  31 18/312 (5.77%)  20
Dermatitis acneiform  1  42/304 (13.82%)  119 0/312 (0.00%)  0
Dry skin  1  43/304 (14.14%)  61 11/312 (3.53%)  13
Hirsutism  1  5/95 (5.26%)  5 0/107 (0.00%)  0
Pruritus  1  31/304 (10.20%)  48 8/312 (2.56%)  9
Rash  1  125/304 (41.12%)  346 20/312 (6.41%)  23
Rash generalised  1  28/304 (9.21%)  62 5/312 (1.60%)  5
Vascular disorders     
Hypertension  1  16/304 (5.26%)  22 29/312 (9.29%)  41
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00982111     History of Changes
Other Study ID Numbers: 13908
2009-012574-12 ( EudraCT Number )
CP11-0805 ( Other Identifier: ImClone Systems )
I4X-IE-JFCB ( Other Identifier: Eli Lilly and Company )
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: November 28, 2018