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A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients

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ClinicalTrials.gov Identifier: NCT01020786
Recruitment Status : Completed
First Posted : November 26, 2009
Results First Posted : March 16, 2012
Last Update Posted : August 27, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Small Cell Lung Cancer
Interventions Drug: Pemetrexed
Drug: Carboplatin
Enrollment 109
Recruitment Details  
Pre-assignment Details

Induction period: pemetrexed and carboplatin were administered for 4 cycles (1 cycle=21 days). Participants with documented complete response (CR), partial response (PR), or stable disease (SD) entered the maintenance therapy period (fifth cycle and after).

Maintenance period: pemetrexed monotherapy until a discontinuation criterion was met.

Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Period Title: Induction Period
Started 109
Completed 60 [1]
Not Completed 49
Reason Not Completed
Entry Criteria Not Met             2
Adverse Event             10
Progressive Disease             31
Investigator Decision             3
Withdrawal by Subject             3
[1]
Completed induction therapy. Completed=starting the maintenance therapy.
Period Title: Maintenance Period
Started 60
Completed 0
Not Completed 60
Reason Not Completed
Adverse Event             8
Progressive Disease             43
Withdrawal by Subject             8
Sponsor Decision             1
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Overall Number of Baseline Participants 109
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants
63.35  (8.692)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
Female
40
  36.7%
Male
69
  63.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 109 participants
109
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 109 participants
109
Percentage of Participants in Each Smoking Status Category at Study Entry   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 109 participants
Current Smoker 8.3
Former Smoker 61.5
Never Smoker 30.3
Unknown 0.0
[1]
Measure Description: Percentage of participants in each category for smoking status. All of the percentages do not add up to 100% because of rounding.
Percentage of Participants in Each Histology Category   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 109 participants
Adenocarcinoma Lung 97.2
Large Cell Lung Carcinoma 2.8
Carcinoma, Non-small Cell, Lung Not Otherwise S 0
[1]
Measure Description: Percentage of participants in each of the following categories: adenocarcinoma, large cell lung carcinoma, and carcinoma, non-small cell, lung not otherwise specified (NOS).
Percentage of Participants in Each Disease Stage   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 109 participants
Stage IIIb 30.3
Stage IV 66.1
Other 3.7
[1]
Measure Description: Percentage of participants in each disease stage category. 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 - cancer spread to opposite side of chest, more than 1 tumor within same lobe of lung; Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver. All of the percentages do not add up to 100% because of rounding.
Percentage of Participants in Each Epidermal Growth Factor Receptor (EGFR) Mutation Status Category   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 109 participants
Positive 22.0
Negative 57.8
Unknown 2.8
Not Done 17.4
[1]
Measure Description: Percentage of participants in each EGFR mutation status category.
Percentage of Participants in Each Eastern Cooperative Oncology Group (ECOG) Status   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 109 participants
0 - Fully Active 33.9
1 - Ambulatory, Restricted Strenuous Activity 66.1
[1]
Measure Description:

ECOG Performance Status (PS). 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
1.Primary Outcome
Title Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods
Hide Description PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.
Time Frame Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 31 participants were censored as they received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m2) of pemetrexed given intravenously (IV) on Day 1 of every 21 day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 for participant, given IV on Day 1 of every 21 day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m2 of pemetrexed given IV on Day 1 of every 21 day cycle until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 109
Median (95% Confidence Interval)
Unit of Measure: months
5.6
(4.3 to 7.2)
2.Secondary Outcome
Title Overall Survival (OS) During the Induction and Maintenance Therapy Periods
Hide Description OS was defined as the time from the enrollment date to the date of death from any cause. For participants who were alive, OS was censored at the last contact.
Time Frame Enrollment to the date of death from any cause (up to 30.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 79 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint (EP) of PFS. There were 48 participants censored at the final endpoint data cut-off.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 109
Median (95% Confidence Interval)
Unit of Measure: months
Overall Survival (OS) at primary endpoint
NA [1] 
(NA to NA)
Overall Survival (OS) at final endpoint
20.2 [2] 
(16.7 to NA)
[1]
The median and 95% confidence interval were not calculable because an insufficient number of participants reached the event at the time of the data cutoff.
[2]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the time of final data cutoff.
3.Secondary Outcome
Title Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods
Hide Description Calculated as the percentage of participants who achieved a confirmed CR, PR, or SD. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria.
Time Frame Enrollment to date of progressive disease (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR+PR
34.9
(26.0 to 44.6)
CR+PR+SD
72.5
(63.1 to 80.6)
4.Secondary Outcome
Title Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods
Hide Description Calculated as the percentage of participants who achieved a confirmed CR or PR. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria.
Time Frame Enrollment to date of progressive disease (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 109
Measure Type: Number
Unit of Measure: percentage of participants
CR 0.0
PR 34.9
5.Secondary Outcome
Title Progression Free Survival (PFS) During the Maintenance Therapy Period
Hide Description Measured from the date of the first dose of the maintenance therapy. Calculated by subtracting induction therapy period from PFS. Tumor response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0; define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.
Time Frame From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set: Maintenance-treated participants who received maintenance therapy with pemetrexed; 20 and 12 participants were censored at time of primary endpoint (18 months) and final endpoint. They received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD at cut-off.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: months
PFS at primary endpoint
3.9
(2.8 to 5.0)
PFS at final endpoint
3.9
(3.2 to 5.2)
6.Secondary Outcome
Title Overall Survival (OS) During the Maintenance Therapy Period
Hide Description OS was defined as the duration from the date of the first dose of the maintenance therapy to the date of death from any cause and was calculated by subtracting the induction therapy period from OS. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. For participants who were alive, OS was censored at the last contact.
Time Frame From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed; 56 participants and 38 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint, PFS, and final endpoint, respectively.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: months
Overall Survival (OS) at primary endpoint
NA [1] 
(NA to NA)
Overall Survival (OS) at final endpoint
NA [2] 
(21.0 to NA)
[1]
The median and the 95% confidence interval were not calculable because an insufficient number of participants reached the event at the time of the 2-year data cutoff.
[2]
The median and the upper 95% confidence interval were not calculable because an insufficient number of participants reached the event at the time of final data cutoff.
7.Secondary Outcome
Title Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period
Hide Description Percentage of participants who achieved confirmed CR (disappearance of all target lesions), PR (30% decrease in sum of longest diameter of target lesions), or SD (small changes that do not meet above criteria). Response derived from target lesion assessments performed before maintenance therapy (as baseline), during maintenance therapy (as post-baseline), and non-target lesion assessments performed during maintenance therapy according to RECIST guideline version 1.0, defines when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
Time Frame From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR+PR
3.3
(0.4 to 11.5)
CR+PR+SD
48.3
(35.2 to 61.6)
8.Secondary Outcome
Title Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period
Hide Description Calculated as the percentage of participants who achieved a CR, PR, or SD (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria.
Time Frame Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.7
(73.1 to 88.4)
9.Secondary Outcome
Title Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period
Hide Description Calculated as percentage of participants who achieved a CR or PR (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria.
Time Frame Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description:

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.5
(29.4 to 48.3)
Time Frame Treatment period plus 30 day follow-up period (up to 30.8 months)
Adverse Event Reporting Description Adverse events were updated to add the adverse events occurring after the data cut-off date for the primary endpoint (PFS) to those events previously reported.
 
Arm/Group Title Pemetrexed + Carboplatin
Hide Arm/Group Description

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

All-Cause Mortality
Pemetrexed + Carboplatin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Pemetrexed + Carboplatin
Affected / at Risk (%) # Events
Total   17/109 (15.60%)    
Blood and lymphatic system disorders   
Anaemia  1  1/109 (0.92%)  1
Disseminated intravascular coagulation  1  1/109 (0.92%)  1
Febrile neutropenia  1  1/109 (0.92%)  1
Thrombocytopenia  1  3/109 (2.75%)  3
Cardiac disorders   
Congestive cardiomyopathy  1  1/109 (0.92%)  1
Endocrine disorders   
Inappropriate antidiuretic hormone secretion  1  1/109 (0.92%)  1
Gastrointestinal disorders   
Dysphagia  1  1/109 (0.92%)  1
Gastric ulcer  1  1/109 (0.92%)  1
Gastric ulcer haemorrhage  1  1/109 (0.92%)  1
General disorders   
Obstruction  1  1/109 (0.92%)  1
Hepatobiliary disorders   
Hyperplastic cholecystopathy  1  1/109 (0.92%)  1
Infections and infestations   
Bronchitis  1  1/109 (0.92%)  1
Bronchopneumonia  1  1/109 (0.92%)  1
Cellulitis  1  1/109 (0.92%)  1
Tonsillitis  1  1/109 (0.92%)  1
Investigations   
Blood potassium decreased  1  1/109 (0.92%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  1/109 (0.92%)  1
Dehydration  1  1/109 (0.92%)  1
Musculoskeletal and connective tissue disorders   
Trigger finger  1  1/109 (0.92%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour pain  1  1/109 (0.92%)  1
Nervous system disorders   
Dizziness  1  1/109 (0.92%)  1
Psychiatric disorders   
Depression  1  1/109 (0.92%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/109 (0.92%)  1
Dyspnoea  1  1/109 (0.92%)  1
Interstitial lung disease  1  1/109 (0.92%)  1
Pneumonitis  1  1/109 (0.92%)  1
Vascular disorders   
Iliac artery occlusion  1  1/109 (0.92%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed + Carboplatin
Affected / at Risk (%) # Events
Total   109/109 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  47/109 (43.12%)  59
Leukopenia  1  44/109 (40.37%)  147
Lymphopenia  1  14/109 (12.84%)  23
Neutropenia  1  58/109 (53.21%)  193
Thrombocytopenia  1  30/109 (27.52%)  84
Gastrointestinal disorders   
Abdominal pain  1  9/109 (8.26%)  15
Abdominal pain upper  1  7/109 (6.42%)  7
Cheilitis  1  6/109 (5.50%)  6
Constipation  1  52/109 (47.71%)  110
Diarrhoea  1  25/109 (22.94%)  37
Nausea  1  81/109 (74.31%)  206
Stomatitis  1  22/109 (20.18%)  27
Vomiting  1  46/109 (42.20%)  71
General disorders   
Fatigue  1  75/109 (68.81%)  181
Influenza like illness  1  7/109 (6.42%)  8
Injection site reaction  1  10/109 (9.17%)  10
Malaise  1  12/109 (11.01%)  19
Oedema  1  8/109 (7.34%)  8
Pyrexia  1  35/109 (32.11%)  56
Infections and infestations   
Nasopharyngitis  1  7/109 (6.42%)  10
Pneumonia  1  10/109 (9.17%)  12
Investigations   
Alanine aminotransferase increased  1  62/109 (56.88%)  152
Aspartate aminotransferase increased  1  60/109 (55.05%)  153
Blood albumin decreased  1  15/109 (13.76%)  19
Blood alkaline phosphatase increased  1  20/109 (18.35%)  23
Blood bilirubin increased  1  7/109 (6.42%)  12
Blood calcium decreased  1  11/109 (10.09%)  17
Blood creatinine increased  1  9/109 (8.26%)  17
Blood lactate dehydrogenase increased  1  38/109 (34.86%)  72
Blood potassium increased  1  7/109 (6.42%)  11
Blood sodium decreased  1  7/109 (6.42%)  15
Blood urea increased  1  10/109 (9.17%)  16
Gamma-glutamyltransferase increased  1  31/109 (28.44%)  42
Haemoglobin decreased  1  52/109 (47.71%)  79
Neutrophil count decreased  1  30/109 (27.52%)  98
Platelet count decreased  1  65/109 (59.63%)  225
Red blood cell count decreased  1  8/109 (7.34%)  8
Weight decreased  1  11/109 (10.09%)  15
White blood cell count decreased  1  42/109 (38.53%)  131
Metabolism and nutrition disorders   
Decreased appetite  1  82/109 (75.23%)  199
Hypocalcaemia  1  8/109 (7.34%)  15
Hyponatraemia  1  6/109 (5.50%)  6
Musculoskeletal and connective tissue disorders   
Back pain  1  14/109 (12.84%)  14
Myalgia  1  6/109 (5.50%)  7
Nervous system disorders   
Dizziness  1  20/109 (18.35%)  27
Dysgeusia  1  11/109 (10.09%)  13
Headache  1  15/109 (13.76%)  20
Peripheral sensory neuropathy  1  9/109 (8.26%)  12
Psychiatric disorders   
Insomnia  1  23/109 (21.10%)  28
Respiratory, thoracic and mediastinal disorders   
Cough  1  16/109 (14.68%)  18
Dyspnoea  1  12/109 (11.01%)  14
Epistaxis  1  9/109 (8.26%)  10
Haemoptysis  1  8/109 (7.34%)  12
Hiccups  1  17/109 (15.60%)  34
Skin and subcutaneous tissue disorders   
Alopecia  1  8/109 (7.34%)  8
Pruritus  1  10/109 (9.17%)  12
Rash  1  37/109 (33.94%)  50
Skin hyperpigmentation  1  8/109 (7.34%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01020786    
Other Study ID Numbers: 12628
H3E-JE-JMII ( Other Identifier: Eli Lilly and Company )
First Submitted: November 24, 2009
First Posted: November 26, 2009
Results First Submitted: January 12, 2012
Results First Posted: March 16, 2012
Last Update Posted: August 27, 2013