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Study of Participants With Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00948675
Recruitment Status : Completed
First Posted : July 29, 2009
Results First Posted : April 2, 2014
Last Update Posted : February 12, 2021
Sponsor:
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 Advanced Non-Small Cell Lung Cancer
Interventions Drug: Pemetrexed
Drug: Carboplatin
Drug: Paclitaxel
Biological: Bevacizumab
Enrollment 361
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pemetrexed + Carboplatin Paclitaxel + Carboplatin + Bevacizumab
Hide Arm/Group Description

Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.

Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.

Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.

Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Period Title: Overall Study
Started 182 179
Completed 175 175
Not Completed 7 4
Reason Not Completed
Lost to Follow-up             2             0
Treatment ongoing             5             4
Arm/Group Title Pemetrexed + Carboplatin Paclitaxel + Carboplatin + Bevacizumab Total
Hide Arm/Group Description

Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.

Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.

Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.

Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Total of all reporting groups
Overall Number of Baseline Participants 182 179 361
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 182 participants 179 participants 361 participants
64.8  (9.62) 64.6  (8.82) 64.7  (9.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 179 participants 361 participants
Female
77
  42.3%
75
  41.9%
152
  42.1%
Male
105
  57.7%
104
  58.1%
209
  57.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 179 participants 361 participants
Hispanic or Latino
4
   2.2%
5
   2.8%
9
   2.5%
Not Hispanic or Latino
178
  97.8%
174
  97.2%
352
  97.5%
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 182 participants 179 participants 361 participants
American Indian or Alaska Native
0
   0.0%
2
   1.1%
2
   0.6%
Asian
4
   2.2%
0
   0.0%
4
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
   6.0%
20
  11.2%
31
   8.6%
White
165
  90.7%
157
  87.7%
322
  89.2%
More than one race
2
   1.1%
0
   0.0%
2
   0.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 182 participants 179 participants 361 participants
182 179 361
1.Primary Outcome
Title Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Hide Description G4PFS was defined as the duration from the date of randomization to the earliest occurrence date of one of the following three events: Common Terminology Criteria (CTC) grade 4 adverse events (G4AEs), or progressive disease (PD) or death from any cause, whichever occurred earlier. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no G4AEs, or PD, or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.
Time Frame Randomization to measured progressive disease or treatment discontinuation up to 39.49 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. The number of participants censored was 30 for pemetrexed + carboplatin group and 35 for paclitaxel + carboplatin + bevacizumab group.
Arm/Group Title Pemetrexed + Carboplatin Paclitaxel + Carboplatin + Bevacizumab
Hide Arm/Group Description:

Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.

Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.

Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.

Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Overall Number of Participants Analyzed 182 179
Median (90% Confidence Interval)
Unit of Measure: months
3.91
(2.73 to 4.37)
2.86
(2.20 to 4.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Paclitaxel + Carboplatin + Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the duration from the date of randomization to the date of progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.
Time Frame Randomization to measured progressive disease up to 39.49 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. The number of participants censored was 35 for pemetrexed + carboplatin group and 49 for paclitaxel + carboplatin + bevacizumab group.
Arm/Group Title Pemetrexed + Carboplatin Paclitaxel + Carboplatin + Bevacizumab
Hide Arm/Group Description:

Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.

Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.

Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.

Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Overall Number of Participants Analyzed 182 179
Median (90% Confidence Interval)
Unit of Measure: months
4.44
(4.21 to 5.32)
5.45
(5.03 to 5.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Paclitaxel + Carboplatin + Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.610
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.
Time Frame Randomization to date of death from any cause up to 39.49 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. The number of participants censored was 52 for pemetrexed + carboplatin group and 56 for paclitaxel + carboplatin + bevacizumab group.
Arm/Group Title Pemetrexed + Carboplatin Paclitaxel + Carboplatin + Bevacizumab
Hide Arm/Group Description:

Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.

Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.

Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.

Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Overall Number of Participants Analyzed 182 179
Median (90% Confidence Interval)
Unit of Measure: months
10.51
(9.26 to 11.96)
11.66
(9.17 to 14.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Paclitaxel + Carboplatin + Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.615
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Complete Response or Partial Response (Overall Tumor Response Rate)
Hide Description Overall Response rate (ORR) is the percentage of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.
Time Frame Baseline to date of objective progressive disease up to 39.49 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Pemetrexed + Carboplatin Paclitaxel + Carboplatin + Bevacizumab
Hide Arm/Group Description:

Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.

Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.

Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.

Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Overall Number of Participants Analyzed 182 179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.6
(17.7 to 30.5)
27.4
(21.0 to 34.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Paclitaxel + Carboplatin + Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.414
Comments [Not Specified]
Method Pearson Chi-square Test
Comments [Not Specified]
5.Secondary Outcome
Title Disease Control Rates Defined as Complete Response (CR), Partial Response (PR), and Stable Disease (SD)
Hide Description Disease control rate is the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
Time Frame Baseline to date of objective progressive disease up to 39.49 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Pemetrexed + Carboplatin Paclitaxel + Carboplatin + Bevacizumab
Hide Arm/Group Description:

Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.

Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.

Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.

Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Overall Number of Participants Analyzed 182 179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
59.9
(52.4 to 67.1)
57.0
(49.4 to 64.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Paclitaxel + Carboplatin + Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.575
Comments [Not Specified]
Method Pearson Chi-square Test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Only those participants who received any amount of study drug are included in the safety analysis. Participants who died from progressive disease are not considered adverse events.
 
Arm/Group Title Pemetrexed + Carboplatin Paclitaxel + Carboplatin + Bevacizumab
Hide Arm/Group Description

Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.

Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.

Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.

Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

All-Cause Mortality
Pemetrexed + Carboplatin Paclitaxel + Carboplatin + Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Pemetrexed + Carboplatin Paclitaxel + Carboplatin + Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   73/171 (42.69%)      64/166 (38.55%)    
Blood and lymphatic system disorders     
Anaemia  1  12/171 (7.02%)  12 2/166 (1.20%)  2
Febrile neutropenia  1  0/171 (0.00%)  0 4/166 (2.41%)  4
Haemorrhagic anaemia  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Leukopenia  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Neutropenia  1 [1]  5/171 (2.92%)  5 5/166 (3.01%)  5
Thrombocytopenia  1  4/171 (2.34%)  5 2/166 (1.20%)  2
Cardiac disorders     
Angina unstable  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Atrial fibrillation  1  2/171 (1.17%)  2 0/166 (0.00%)  0
Atrial flutter  1  3/171 (1.75%)  4 1/166 (0.60%)  1
Bradycardia  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Cardiac failure congestive  1  1/171 (0.58%)  1 3/166 (1.81%)  3
Cardiomyopathy acute  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Coronary artery disease  1  2/171 (1.17%)  2 0/166 (0.00%)  0
Myocardial infarction  1 [2]  1/171 (0.58%)  1 1/166 (0.60%)  1
Nodal arrhythmia  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Pericardial effusion  1  2/171 (1.17%)  3 0/166 (0.00%)  0
Pericarditis  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Supraventricular tachycardia  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Ventricular tachycardia  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Eye disorders     
Blindness  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Gastrointestinal disorders     
Abdominal pain  1  2/171 (1.17%)  2 1/166 (0.60%)  1
Colitis  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Constipation  1  1/171 (0.58%)  1 2/166 (1.20%)  2
Diarrhoea  1  3/171 (1.75%)  3 6/166 (3.61%)  6
Diverticulum intestinal haemorrhagic  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Faeces discoloured  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Haematemesis  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Haematochezia  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Large intestine perforation  1  0/171 (0.00%)  0 2/166 (1.20%)  2
Nausea  1  5/171 (2.92%)  5 8/166 (4.82%)  8
Oesophagitis  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Pancreatitis  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Rectal obstruction  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Small intestinal obstruction  1  3/171 (1.75%)  3 1/166 (0.60%)  1
Vomiting  1  3/171 (1.75%)  3 9/166 (5.42%)  9
General disorders     
Asthenia  1  4/171 (2.34%)  4 3/166 (1.81%)  3
Catheter site pain  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Chest pain  1  5/171 (2.92%)  5 2/166 (1.20%)  2
Disease progression  1  2/171 (1.17%)  2 0/166 (0.00%)  0
Mucosal inflammation  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Pain  1  0/171 (0.00%)  0 3/166 (1.81%)  3
Pyrexia  1  1/171 (0.58%)  1 2/166 (1.20%)  2
Hepatobiliary disorders     
Hyperbilirubinaemia  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Infections and infestations     
Cellulitis  1  2/171 (1.17%)  2 1/166 (0.60%)  1
Clostridium difficile colitis  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Device related infection  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Device related sepsis  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Diverticulitis  1  0/171 (0.00%)  0 2/166 (1.20%)  2
Osteomyelitis  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Pneumonia  1 [3]  13/171 (7.60%)  15 6/166 (3.61%)  6
Pneumonia mycoplasmal  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Psoas abscess  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Sepsis  1  1/171 (0.58%)  1 1/166 (0.60%)  1
Urinary tract infection  1  1/171 (0.58%)  2 3/166 (1.81%)  3
Injury, poisoning and procedural complications     
Cervical vertebral fracture  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Clavicle fracture  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Fall  1  1/171 (0.58%)  1 1/166 (0.60%)  1
Femur fracture  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Overdose  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Pelvic fracture  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Spinal compression fracture  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Toxicity to various agents  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Investigations     
Blood creatinine increased  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Haemoglobin decreased  1  3/171 (1.75%)  3 0/166 (0.00%)  0
Platelet count decreased  1  2/171 (1.17%)  2 0/166 (0.00%)  0
Troponin increased  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Weight decreased  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Metabolism and nutrition disorders     
Dehydration  1  9/171 (5.26%)  9 11/166 (6.63%)  12
Failure to thrive  1  1/171 (0.58%)  1 1/166 (0.60%)  1
Hypercalcaemia  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Hyperglycaemia  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Hypoalbuminaemia  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Hypocalcaemia  1  1/171 (0.58%)  1 2/166 (1.20%)  2
Hypokalaemia  1  2/171 (1.17%)  2 2/166 (1.20%)  2
Hyponatraemia  1  1/171 (0.58%)  1 1/166 (0.60%)  1
Hypovolaemia  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Lactic acidosis  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Back pain  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Bone lesion  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Bone pain  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Groin pain  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Hypertrophic osteoarthropathy  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Muscular weakness  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Musculoskeletal chest pain  1  1/171 (0.58%)  1 2/166 (1.20%)  2
Neck pain  1  1/171 (0.58%)  1 1/166 (0.60%)  1
Pathological fracture  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Malignant pleural effusion  1  2/171 (1.17%)  2 0/166 (0.00%)  0
Metastases to meninges  1  0/171 (0.00%)  0 2/166 (1.20%)  2
Metastatic neoplasm  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Neoplasm  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Nervous system disorders     
Autonomic nervous system imbalance  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Balance disorder  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Cerebrovascular accident  1 [4]  1/171 (0.58%)  1 0/166 (0.00%)  0
Depressed level of consciousness  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Dizziness  1  1/171 (0.58%)  1 1/166 (0.60%)  1
Embolic stroke  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Headache  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Lacunar infarction  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Neuropathy peripheral  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Spinal cord compression  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Syncope  1  3/171 (1.75%)  3 2/166 (1.20%)  2
Transient ischaemic attack  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Psychiatric disorders     
Confusional state  1  2/171 (1.17%)  2 0/166 (0.00%)  0
Emotional distress  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Mental status changes  1  0/171 (0.00%)  0 3/166 (1.81%)  3
Psychotic disorder  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Suicidal ideation  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Renal and urinary disorders     
Haematuria  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Nephrotic syndrome  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Renal failure  1  2/171 (1.17%)  2 1/166 (0.60%)  1
Renal failure acute  1 [1]  4/171 (2.34%)  4 1/166 (0.60%)  1
Urinary retention  1  1/171 (0.58%)  1 1/166 (0.60%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  2/171 (1.17%)  2 0/166 (0.00%)  0
Aspiration  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Chronic obstructive pulmonary disease  1  4/171 (2.34%)  4 2/166 (1.20%)  2
Dyspnoea  1  6/171 (3.51%)  8 5/166 (3.01%)  5
Dyspnoea exertional  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Epistaxis  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Haemoptysis  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Hydropneumothorax  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Hypoxia  1  0/171 (0.00%)  0 3/166 (1.81%)  3
Pleural effusion  1  3/171 (1.75%)  3 3/166 (1.81%)  3
Pneumothorax  1  1/171 (0.58%)  1 1/166 (0.60%)  1
Pulmonary embolism  1 [5]  8/171 (4.68%)  8 5/166 (3.01%)  5
Respiratory failure  1 [6]  3/171 (1.75%)  3 4/166 (2.41%)  4
Stridor  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  3/171 (1.75%)  3 3/166 (1.81%)  3
Embolism  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Haematoma  1  1/171 (0.58%)  1 1/166 (0.60%)  1
Haemorrhage  1  1/171 (0.58%)  1 0/166 (0.00%)  0
Hypertension  1  0/171 (0.00%)  0 1/166 (0.60%)  1
Hypotension  1  4/171 (2.34%)  4 4/166 (2.41%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
[1]
Event resulted in 1 death in the Pemetrexed + Carboplatin arm
[2]
Event resulted in death in both arms
[3]
Event resulted in 2 deaths in the Pemetrexed + Carboplatin arm
[4]
Event resulted in death
[5]
Event resulted in 1 death in the Paclitaxel + Carboplatin + Bevacizumab arm
[6]
Event resulted in 2 deaths in the Pemetrexed + Carboplatin arm and 2 deaths in the Paclitaxel + Carboplatin + Bevacizumab arm
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed + Carboplatin Paclitaxel + Carboplatin + Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   167/171 (97.66%)      161/166 (96.99%)    
Blood and lymphatic system disorders     
Anaemia  1  87/171 (50.88%)  126 58/166 (34.94%)  79
Leukopenia  1  39/171 (22.81%)  61 32/166 (19.28%)  46
Neutropenia  1  57/171 (33.33%)  101 79/166 (47.59%)  140
Thrombocytopenia  1  66/171 (38.60%)  119 47/166 (28.31%)  73
Eye disorders     
Lacrimation increased  1  14/171 (8.19%)  15 1/166 (0.60%)  1
Gastrointestinal disorders     
Abdominal pain  1  14/171 (8.19%)  16 14/166 (8.43%)  16
Constipation  1  73/171 (42.69%)  89 67/166 (40.36%)  70
Diarrhoea  1  29/171 (16.96%)  34 45/166 (27.11%)  63
Dyspepsia  1  20/171 (11.70%)  22 15/166 (9.04%)  16
Dysphagia  1  4/171 (2.34%)  4 10/166 (6.02%)  11
Gastrooesophageal reflux disease  1  5/171 (2.92%)  5 10/166 (6.02%)  10
Nausea  1  98/171 (57.31%)  130 69/166 (41.57%)  83
Stomatitis  1  14/171 (8.19%)  16 15/166 (9.04%)  17
Vomiting  1  48/171 (28.07%)  60 30/166 (18.07%)  43
General disorders     
Asthenia  1  10/171 (5.85%)  12 20/166 (12.05%)  22
Chest pain  1  16/171 (9.36%)  17 12/166 (7.23%)  12
Chills  1  12/171 (7.02%)  13 8/166 (4.82%)  9
Fatigue  1  109/171 (63.74%)  130 89/166 (53.61%)  105
Mucosal inflammation  1  11/171 (6.43%)  11 17/166 (10.24%)  18
Oedema peripheral  1  32/171 (18.71%)  42 12/166 (7.23%)  13
Pain  1  8/171 (4.68%)  8 9/166 (5.42%)  9
Pyrexia  1  14/171 (8.19%)  15 11/166 (6.63%)  13
Infections and infestations     
Bronchitis  1  5/171 (2.92%)  6 12/166 (7.23%)  14
Pneumonia  1  9/171 (5.26%)  9 5/166 (3.01%)  5
Sinusitis  1  10/171 (5.85%)  11 11/166 (6.63%)  13
Urinary tract infection  1  18/171 (10.53%)  18 10/166 (6.02%)  10
Investigations     
Alanine aminotransferase increased  1  14/171 (8.19%)  19 6/166 (3.61%)  8
Aspartate aminotransferase increased  1  14/171 (8.19%)  19 6/166 (3.61%)  6
Blood creatinine increased  1  13/171 (7.60%)  15 4/166 (2.41%)  4
Haemoglobin decreased  1  23/171 (13.45%)  33 7/166 (4.22%)  9
Neutrophil count decreased  1  12/171 (7.02%)  17 18/166 (10.84%)  20
Platelet count decreased  1  20/171 (11.70%)  35 8/166 (4.82%)  8
Weight decreased  1  15/171 (8.77%)  16 31/166 (18.67%)  31
White blood cell count decreased  1  8/171 (4.68%)  14 12/166 (7.23%)  14
Metabolism and nutrition disorders     
Decreased appetite  1  54/171 (31.58%)  62 58/166 (34.94%)  65
Dehydration  1  20/171 (11.70%)  23 20/166 (12.05%)  23
Hyperglycaemia  1  33/171 (19.30%)  46 22/166 (13.25%)  31
Hypokalaemia  1  24/171 (14.04%)  27 15/166 (9.04%)  20
Hypomagnesaemia  1  21/171 (12.28%)  24 24/166 (14.46%)  27
Hyponatraemia  1  17/171 (9.94%)  18 16/166 (9.64%)  19
Musculoskeletal and connective tissue disorders     
Arthralgia  1  18/171 (10.53%)  24 38/166 (22.89%)  49
Back pain  1  20/171 (11.70%)  22 15/166 (9.04%)  19
Bone pain  1  5/171 (2.92%)  5 17/166 (10.24%)  19
Musculoskeletal chest pain  1  12/171 (7.02%)  15 6/166 (3.61%)  6
Musculoskeletal pain  1  10/171 (5.85%)  10 11/166 (6.63%)  11
Myalgia  1  10/171 (5.85%)  11 22/166 (13.25%)  23
Pain in extremity  1  13/171 (7.60%)  14 20/166 (12.05%)  22
Nervous system disorders     
Dizziness  1  25/171 (14.62%)  26 19/166 (11.45%)  19
Dysgeusia  1  19/171 (11.11%)  22 25/166 (15.06%)  28
Headache  1  22/171 (12.87%)  22 25/166 (15.06%)  31
Neuropathy peripheral  1  9/171 (5.26%)  10 35/166 (21.08%)  37
Peripheral sensory neuropathy  1  9/171 (5.26%)  11 28/166 (16.87%)  34
Psychiatric disorders     
Anxiety  1  17/171 (9.94%)  17 13/166 (7.83%)  14
Depression  1  12/171 (7.02%)  12 10/166 (6.02%)  10
Insomnia  1  34/171 (19.88%)  36 32/166 (19.28%)  32
Renal and urinary disorders     
Proteinuria  1  11/171 (6.43%)  12 18/166 (10.84%)  22
Respiratory, thoracic and mediastinal disorders     
Cough  1  34/171 (19.88%)  37 24/166 (14.46%)  25
Dysphonia  1  5/171 (2.92%)  5 16/166 (9.64%)  16
Dyspnoea  1  39/171 (22.81%)  42 32/166 (19.28%)  36
Epistaxis  1  15/171 (8.77%)  16 42/166 (25.30%)  51
Haemoptysis  1  3/171 (1.75%)  3 9/166 (5.42%)  9
Oropharyngeal pain  1  8/171 (4.68%)  9 10/166 (6.02%)  12
Skin and subcutaneous tissue disorders     
Alopecia  1  14/171 (8.19%)  14 56/166 (33.73%)  58
Dry skin  1  11/171 (6.43%)  11 3/166 (1.81%)  3
Rash  1  21/171 (12.28%)  24 15/166 (9.04%)  15
Vascular disorders     
Hypertension  1  3/171 (1.75%)  3 26/166 (15.66%)  27
Hypotension  1  12/171 (7.02%)  14 10/166 (6.02%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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: NCT00948675    
Other Study ID Numbers: 13258
H3E-US-S130 ( Other Identifier: Eli Lilly and Company )
First Submitted: July 28, 2009
First Posted: July 29, 2009
Results First Submitted: January 14, 2014
Results First Posted: April 2, 2014
Last Update Posted: February 12, 2021