Trial Outcomes & Findings for A Study of Pemetrexed and Bevacizumab for Participants With Advanced Non-Small Cell Cancer (NCT NCT01004250)
NCT ID: NCT01004250
Last Updated: 2014-05-21
Results Overview
Progression-Free Survival (PFS) is defined as the time from the date of study enrollment to the first date of objectively determined PD or death from any cause. PD is defined using Response Evaluation Criteria in Solid Tumours (RECIST) Guidelines (Version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last objective progression-free disease assessment. For participants who receive subsequent systemic anticancer therapy, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation systemic therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
From enrollment to the first date of objectively determined Progressive Disease (PD) or death from any cause (every other cycle during study treatment and then every 6 weeks during follow-up period)(Baseline up to 36.1 Months)
Results posted on
2014-05-21
Participant Flow
The study had 3 periods: a baseline period; a study treatment period, including both induction (Ind) and maintenance (Maint) treatment; and a follow-up period.
Participant milestones
| Measure |
Study Treatment
Induction Therapy:
Bevacizumab: 7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 milligram per square meter (mg/m²) given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle (cycle=21 days) and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
|---|---|
|
Induction Therapy Period
STARTED
|
109
|
|
Induction Therapy Period
Received at Least One Dose of Study Drug
|
109
|
|
Induction Therapy Period
Death (Any Cause) or Disease Progression
|
21
|
|
Induction Therapy Period
COMPLETED
|
94
|
|
Induction Therapy Period
NOT COMPLETED
|
15
|
|
Maintenance Therapy Period
STARTED
|
72
|
|
Maintenance Therapy Period
Death (Any Cause) or Disease Progression
|
46
|
|
Maintenance Therapy Period
COMPLETED
|
46
|
|
Maintenance Therapy Period
NOT COMPLETED
|
26
|
|
Follow-Up (FU) Period
STARTED
|
101
|
|
Follow-Up (FU) Period
COMPLETED
|
100
|
|
Follow-Up (FU) Period
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Study Treatment
Induction Therapy:
Bevacizumab: 7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 milligram per square meter (mg/m²) given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle (cycle=21 days) and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
|---|---|
|
Induction Therapy Period
Adverse Event
|
10
|
|
Induction Therapy Period
Entry Criteria Not Met
|
1
|
|
Induction Therapy Period
Withdrawal by Subject
|
2
|
|
Induction Therapy Period
Physician Decision
|
2
|
|
Maintenance Therapy Period
Adverse Event
|
15
|
|
Maintenance Therapy Period
Lost to Follow-up
|
1
|
|
Maintenance Therapy Period
Protocol Violation
|
1
|
|
Maintenance Therapy Period
Withdrawal by Subject
|
5
|
|
Maintenance Therapy Period
Physician Decision
|
4
|
|
Follow-Up (FU) Period
Lost to Follow-up
|
1
|
Baseline Characteristics
A Study of Pemetrexed and Bevacizumab for Participants With Advanced Non-Small Cell Cancer
Baseline characteristics by cohort
| Measure |
Study Treatment
n=109 Participants
Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 8.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
18 participants
n=5 Participants
|
|
ECOG Performance Status
ECOG 0
|
59 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG 1
|
50 Participants
n=5 Participants
|
|
Initial Pathological Diagnosis
Adenocarcinoma
|
99 Participants
n=5 Participants
|
|
Initial Pathological Diagnosis
Large Cell Lung Carcinoma
|
3 Participants
n=5 Participants
|
|
Initial Pathological Diagnosis
Poorly Differentiated NSCLC
|
3 Participants
n=5 Participants
|
|
Initial Pathological Diagnosis
Other
|
4 Participants
n=5 Participants
|
|
Stage of Disease
Stage IIIB
|
10 Participants
n=5 Participants
|
|
Stage of Disease
Stage IV
|
99 Participants
n=5 Participants
|
|
Tobacco Use
Never Smoked
|
15 Participant
n=5 Participants
|
|
Tobacco Use
Ex-Smoker
|
66 Participant
n=5 Participants
|
|
Tobacco Use
Current Smoker
|
28 Participant
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment to the first date of objectively determined Progressive Disease (PD) or death from any cause (every other cycle during study treatment and then every 6 weeks during follow-up period)(Baseline up to 36.1 Months)Population: 30 participants were censored. Participants qualified by the following criteria: * Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer * At least 1 unidimensionally measurable lesion * No concomitant curative anticancer therapy * Treated with at least one dose of study drug
Progression-Free Survival (PFS) is defined as the time from the date of study enrollment to the first date of objectively determined PD or death from any cause. PD is defined using Response Evaluation Criteria in Solid Tumours (RECIST) Guidelines (Version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last objective progression-free disease assessment. For participants who receive subsequent systemic anticancer therapy, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation systemic therapy.
Outcome measures
| Measure |
Study Treatment
n=109 Participants
Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
|---|---|
|
Progression-Free Survival
|
6.9 Months
Interval 5.7 to 8.3
|
SECONDARY outcome
Timeframe: From enrollment to the date of death from any cause (every cycle during study treatment, every 6 weeks during follow-up period until PD, and then at least every 3 Months) (Baseline up to 36.3 Months)Population: 32 participants were censored. All enrolled participants receiving at least one dose of study drug.
Overall Survival (OS) is defined as the time from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS will be censored at the last contact date.
Outcome measures
| Measure |
Study Treatment
n=109 Participants
Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
14.7 Months
Interval 11.5 to 19.7
|
SECONDARY outcome
Timeframe: From enrollment to objectively determined PD (assessment during study treatment completed at every other cycle till PD and at 30 day follow-up)(Baseline up to 104.1 Weeks)Population: Participants qualified by the following criteria: * Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer * At least 1 unidimensionally measurable lesion * No concomitant curative anticancer therapy * Treated with at least one dose of study drug
Overall Response Rate (ORR) is defined as the percentage of participants whose best response is complete response (CR) or partial response (PR) per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.
Outcome measures
| Measure |
Study Treatment
n=109 Participants
Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Confirmed Complete Response or Partial Response During Study Treatment (Induction and Maintenance)
|
42.2 Percentage of Participants
Interval 32.8 to 52.0
|
SECONDARY outcome
Timeframe: From the time of study enrollment to the first date of objectively determined PD during the induction therapy (assessment during study treatment completed at every other cycle up to four cycles) (Baseline up to 4 cycles)Population: Participants qualified by the following criteria: * Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer * At least 1 unidimensionally measurable lesion * No concomitant curative anticancer therapy * Treated with at least one dose of study drug
CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.
Outcome measures
| Measure |
Study Treatment
n=109 Participants
Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Confirmed Response Complete or Partial Response During the Induction Treatment Only
|
34.9 Percentage of Participants
Interval 26.0 to 44.6
|
SECONDARY outcome
Timeframe: From the start of the maintenance to the first date of objectively determined PD during the maintenance therapy (assessment during maintenance treatment completed at every other cycle till PD and at 30 day follow-up)(Cycle 5 up to 104.1 Weeks)Population: Participants qualified by the following criteria: * Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer * At least 1 unidimensionally measurable lesion * No concomitant curative anticancer therapy * Treated with at least one dose of study drug
CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.
Outcome measures
| Measure |
Study Treatment
n=72 Participants
Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Confirmed Complete Response or Partial Response During the Maintenance Therapy Only
|
11.1 Percentage of Participants
Interval 4.9 to 20.7
|
Adverse Events
Induction Therapy
Serious events: 32 serious events
Other events: 105 other events
Deaths: 0 deaths
Maintenance Therapy
Serious events: 14 serious events
Other events: 68 other events
Deaths: 0 deaths
Overall Study Treatment
Serious events: 39 serious events
Other events: 106 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction Therapy
n=109 participants at risk
Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
|
Maintenance Therapy
n=72 participants at risk
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
Overall Study Treatment
n=109 participants at risk
Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/109
|
2.8%
2/72 • Number of events 2
|
1.8%
2/109 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/109
|
2.8%
2/72 • Number of events 2
|
1.8%
2/109 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.92%
1/109 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.92%
1/109 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.92%
1/109 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.92%
1/109 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
3/109 • Number of events 3
|
0.00%
0/72
|
2.8%
3/109 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.8%
3/109 • Number of events 3
|
2.8%
2/72 • Number of events 2
|
3.7%
4/109 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
2/109 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
2.8%
3/109 • Number of events 3
|
|
General disorders
Asthenia
|
0.92%
1/109 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
|
General disorders
Chest pain
|
1.8%
2/109 • Number of events 2
|
0.00%
0/72
|
1.8%
2/109 • Number of events 2
|
|
General disorders
General physical health deterioration
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
General disorders
Impaired healing
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/109
|
4.2%
3/72 • Number of events 3
|
2.8%
3/109 • Number of events 3
|
|
General disorders
Pyrexia
|
3.7%
4/109 • Number of events 4
|
1.4%
1/72 • Number of events 1
|
4.6%
5/109 • Number of events 5
|
|
General disorders
Sudden death
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/109
|
1.4%
1/72 • Number of events 2
|
0.92%
1/109 • Number of events 2
|
|
Infections and infestations
Bronchopneumonia
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.92%
1/109 • Number of events 1
|
2.8%
2/72 • Number of events 2
|
2.8%
3/109 • Number of events 3
|
|
Infections and infestations
Postoperative wound infection
|
1.8%
2/109 • Number of events 2
|
0.00%
0/72
|
1.8%
2/109 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection
|
0.92%
1/109 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
0.92%
1/109 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
2/109 • Number of events 2
|
0.00%
0/72
|
1.8%
2/109 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.92%
1/109 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.92%
1/109 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Nervous system disorders
Coma
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.92%
1/109 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
1.8%
2/109 • Number of events 2
|
|
Nervous system disorders
Transient global amnesia
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.8%
2/109 • Number of events 2
|
0.00%
0/72
|
1.8%
2/109 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
2/109 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
2.8%
3/109 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/109
|
1.4%
1/72 • Number of events 1
|
0.92%
1/109 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
2.8%
3/109 • Number of events 3
|
0.00%
0/72
|
2.8%
3/109 • Number of events 3
|
|
Vascular disorders
Hypotension
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.92%
1/109 • Number of events 1
|
0.00%
0/72
|
0.92%
1/109 • Number of events 1
|
Other adverse events
| Measure |
Induction Therapy
n=109 participants at risk
Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
|
Maintenance Therapy
n=72 participants at risk
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
Overall Study Treatment
n=109 participants at risk
Induction Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.
Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.
Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.
Maintenance Therapy:
Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
8/109 • Number of events 8
|
1.4%
1/72 • Number of events 1
|
8.3%
9/109 • Number of events 9
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
9/109 • Number of events 15
|
5.6%
4/72 • Number of events 12
|
10.1%
11/109 • Number of events 31
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.5%
18/109 • Number of events 29
|
16.7%
12/72 • Number of events 27
|
20.2%
22/109 • Number of events 60
|
|
Cardiac disorders
Palpitations
|
0.00%
0/109
|
5.6%
4/72 • Number of events 4
|
3.7%
4/109 • Number of events 4
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
9/109 • Number of events 10
|
2.8%
2/72 • Number of events 2
|
10.1%
11/109 • Number of events 12
|
|
Eye disorders
Lacrimation increased
|
10.1%
11/109 • Number of events 11
|
9.7%
7/72 • Number of events 9
|
14.7%
16/109 • Number of events 19
|
|
Gastrointestinal disorders
Constipation
|
25.7%
28/109 • Number of events 33
|
22.2%
16/72 • Number of events 21
|
35.8%
39/109 • Number of events 54
|
|
Gastrointestinal disorders
Diarrhoea
|
15.6%
17/109 • Number of events 18
|
15.3%
11/72 • Number of events 12
|
22.9%
25/109 • Number of events 29
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
9/109 • Number of events 10
|
8.3%
6/72 • Number of events 6
|
12.8%
14/109 • Number of events 15
|
|
Gastrointestinal disorders
Gastritis
|
2.8%
3/109 • Number of events 3
|
5.6%
4/72 • Number of events 4
|
5.5%
6/109 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
55.0%
60/109 • Number of events 100
|
23.6%
17/72 • Number of events 27
|
58.7%
64/109 • Number of events 128
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
9/109 • Number of events 13
|
12.5%
9/72 • Number of events 12
|
15.6%
17/109 • Number of events 25
|
|
Gastrointestinal disorders
Vomiting
|
19.3%
21/109 • Number of events 28
|
13.9%
10/72 • Number of events 17
|
22.9%
25/109 • Number of events 45
|
|
General disorders
Asthenia
|
4.6%
5/109 • Number of events 6
|
5.6%
4/72 • Number of events 6
|
8.3%
9/109 • Number of events 12
|
|
General disorders
Chest pain
|
6.4%
7/109 • Number of events 7
|
4.2%
3/72 • Number of events 3
|
8.3%
9/109 • Number of events 10
|
|
General disorders
Fatigue
|
38.5%
42/109 • Number of events 47
|
27.8%
20/72 • Number of events 22
|
46.8%
51/109 • Number of events 63
|
|
General disorders
Influenza like illness
|
0.92%
1/109 • Number of events 1
|
8.3%
6/72 • Number of events 6
|
6.4%
7/109 • Number of events 7
|
|
General disorders
Mucosal inflammation
|
11.0%
12/109 • Number of events 15
|
6.9%
5/72 • Number of events 6
|
12.8%
14/109 • Number of events 20
|
|
General disorders
Oedema peripheral
|
4.6%
5/109 • Number of events 5
|
13.9%
10/72 • Number of events 10
|
12.8%
14/109 • Number of events 14
|
|
General disorders
Pain
|
1.8%
2/109 • Number of events 2
|
6.9%
5/72 • Number of events 5
|
6.4%
7/109 • Number of events 7
|
|
General disorders
Pyrexia
|
10.1%
11/109 • Number of events 12
|
12.5%
9/72 • Number of events 22
|
15.6%
17/109 • Number of events 34
|
|
Infections and infestations
Infection
|
1.8%
2/109 • Number of events 2
|
5.6%
4/72 • Number of events 5
|
5.5%
6/109 • Number of events 7
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
3/109 • Number of events 3
|
4.2%
3/72 • Number of events 4
|
5.5%
6/109 • Number of events 7
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
2/109 • Number of events 2
|
9.7%
7/72 • Number of events 8
|
7.3%
8/109 • Number of events 10
|
|
Investigations
Blood creatinine increased
|
0.00%
0/109
|
9.7%
7/72 • Number of events 7
|
6.4%
7/109 • Number of events 7
|
|
Investigations
Haemoglobin decreased
|
2.8%
3/109 • Number of events 3
|
6.9%
5/72 • Number of events 5
|
6.4%
7/109 • Number of events 9
|
|
Investigations
Weight decreased
|
7.3%
8/109 • Number of events 8
|
5.6%
4/72 • Number of events 4
|
10.1%
11/109 • Number of events 11
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
9/109 • Number of events 10
|
20.8%
15/72 • Number of events 18
|
20.2%
22/109 • Number of events 29
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
2/109 • Number of events 2
|
12.5%
9/72 • Number of events 12
|
9.2%
10/109 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
3/109 • Number of events 3
|
4.2%
3/72 • Number of events 3
|
5.5%
6/109 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.6%
5/109 • Number of events 5
|
11.1%
8/72 • Number of events 8
|
11.0%
12/109 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.8%
2/109 • Number of events 2
|
5.6%
4/72 • Number of events 5
|
5.5%
6/109 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
2/109 • Number of events 3
|
6.9%
5/72 • Number of events 7
|
5.5%
6/109 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.92%
1/109 • Number of events 1
|
8.3%
6/72 • Number of events 8
|
6.4%
7/109 • Number of events 9
|
|
Nervous system disorders
Dizziness
|
4.6%
5/109 • Number of events 5
|
6.9%
5/72 • Number of events 5
|
9.2%
10/109 • Number of events 11
|
|
Nervous system disorders
Dysgeusia
|
4.6%
5/109 • Number of events 5
|
6.9%
5/72 • Number of events 5
|
9.2%
10/109 • Number of events 10
|
|
Nervous system disorders
Headache
|
11.0%
12/109 • Number of events 12
|
13.9%
10/72 • Number of events 11
|
17.4%
19/109 • Number of events 22
|
|
Nervous system disorders
Neuropathy peripheral
|
2.8%
3/109 • Number of events 3
|
5.6%
4/72 • Number of events 6
|
5.5%
6/109 • Number of events 9
|
|
Nervous system disorders
Paraesthesia
|
6.4%
7/109 • Number of events 7
|
5.6%
4/72 • Number of events 4
|
9.2%
10/109 • Number of events 11
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
9/109 • Number of events 9
|
13.9%
10/72 • Number of events 12
|
15.6%
17/109 • Number of events 20
|
|
Psychiatric disorders
Anxiety
|
2.8%
3/109 • Number of events 3
|
4.2%
3/72 • Number of events 3
|
5.5%
6/109 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
7.3%
8/109 • Number of events 8
|
5.6%
4/72 • Number of events 4
|
11.0%
12/109 • Number of events 12
|
|
Renal and urinary disorders
Proteinuria
|
4.6%
5/109 • Number of events 5
|
4.2%
3/72 • Number of events 4
|
6.4%
7/109 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.1%
11/109 • Number of events 13
|
20.8%
15/72 • Number of events 19
|
20.2%
22/109 • Number of events 29
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.6%
5/109 • Number of events 5
|
4.2%
3/72 • Number of events 3
|
7.3%
8/109 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.3%
8/109 • Number of events 8
|
20.8%
15/72 • Number of events 19
|
14.7%
16/109 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.7%
16/109 • Number of events 19
|
19.4%
14/72 • Number of events 19
|
25.7%
28/109 • Number of events 38
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.92%
1/109 • Number of events 1
|
9.7%
7/72 • Number of events 8
|
7.3%
8/109 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.4%
7/109 • Number of events 7
|
1.4%
1/72 • Number of events 2
|
7.3%
8/109 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.4%
7/109 • Number of events 7
|
6.9%
5/72 • Number of events 7
|
10.1%
11/109 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.92%
1/109 • Number of events 1
|
5.6%
4/72 • Number of events 4
|
4.6%
5/109 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
3/109 • Number of events 4
|
8.3%
6/72 • Number of events 8
|
7.3%
8/109 • Number of events 11
|
|
Vascular disorders
Hypertension
|
12.8%
14/109 • Number of events 14
|
19.4%
14/72 • Number of events 16
|
21.1%
23/109 • Number of events 26
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60