Trial Outcomes & Findings for Triplet Combination First Line Treatment in Non Small Cell Lung Cancer (NSCLC) (NCT NCT00942825)
NCT ID: NCT00942825
Last Updated: 2017-05-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
195 participants
Primary outcome timeframe
15 June 2009 to 30 September 2012
Results posted on
2017-05-24
Participant Flow
Participant milestones
| Measure |
A CBP501 +Cisplatin + Pemetrexed
CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2
CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
1. CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
2. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
3. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
|
B Cisplatin + Pemetrexed
Cisplatin + Pemetrexed
Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
1. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
2. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
98
|
|
Overall Study
COMPLETED
|
97
|
98
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Triplet Combination First Line Treatment in Non Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
A CBP501 +Cisplatin + Pemetrexed
n=97 Participants
CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2
CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
1. CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
2. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
3. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
|
B Cisplatin + Pemetrexed
n=98 Participants
Cisplatin + Pemetrexed
Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
1. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
2. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 8.66 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 9.03 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 June 2009 to 30 September 2012Population: Treated population
Outcome measures
| Measure |
A CBP501 +Cisplatin + Pemetrexed
n=97 Participants
CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2
CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
1. CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
2. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
3. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
|
B Cisplatin + Pemetrexed
n=98 Participants
Cisplatin + Pemetrexed
Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
1. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
2. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
|
|---|---|---|
|
The Primary Efficacy Endpoint is Progression Free Survival, Analyzed in the Treated Population. PFS is Assessed From Randomization Until Either Tumor Progression, as Per RECIST Criteria, or Until Death Due to Any Reason.
|
140 days
Interval 107.0 to 171.0
|
165 days
Interval 132.0 to 186.0
|
Adverse Events
A CBP501 +Cisplatin + Pemetrexed
Serious events: 37 serious events
Other events: 58 other events
Deaths: 0 deaths
B Cisplatin + Pemetrexed
Serious events: 38 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A CBP501 +Cisplatin + Pemetrexed
n=97 participants at risk
CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2
CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
1. CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
2. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
3. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
|
B Cisplatin + Pemetrexed
n=98 participants at risk
Cisplatin + Pemetrexed
Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
1. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
2. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
11.3%
11/97
|
11.2%
11/98
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
1.0%
1/97
|
1.0%
1/98
|
|
Blood and lymphatic system disorders
leukopenia
|
1.0%
1/97
|
4.1%
4/98
|
|
Blood and lymphatic system disorders
neutropenia
|
9.3%
9/97
|
9.2%
9/98
|
|
Blood and lymphatic system disorders
pancytopenia
|
1.0%
1/97
|
0.00%
0/98
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
2.1%
2/97
|
2.0%
2/98
|
|
Cardiac disorders
atrial flutter
|
0.00%
0/97
|
1.0%
1/98
|
|
Cardiac disorders
cadiac arrest
|
1.0%
1/97
|
0.00%
0/98
|
|
Gastrointestinal disorders
diarrhea
|
1.0%
1/97
|
1.0%
1/98
|
|
Gastrointestinal disorders
GI hemorrage
|
1.0%
1/97
|
0.00%
0/98
|
|
Gastrointestinal disorders
nausea
|
1.0%
1/97
|
3.1%
3/98
|
|
Gastrointestinal disorders
peritonitis
|
1.0%
1/97
|
0.00%
0/98
|
|
Gastrointestinal disorders
retching
|
1.0%
1/97
|
0.00%
0/98
|
|
Gastrointestinal disorders
upper GI hemorrage
|
1.0%
1/97
|
0.00%
0/98
|
|
Gastrointestinal disorders
vomiting
|
1.0%
1/97
|
2.0%
2/98
|
|
General disorders
asthenia
|
4.1%
4/97
|
1.0%
1/98
|
|
General disorders
fatigue
|
2.1%
2/97
|
5.1%
5/98
|
|
General disorders
infusion related reaction
|
1.0%
1/97
|
0.00%
0/98
|
|
General disorders
infusion site reaction
|
1.0%
1/97
|
0.00%
0/98
|
|
General disorders
malaise
|
1.0%
1/97
|
0.00%
0/98
|
|
Immune system disorders
hypersensitivity
|
1.0%
1/97
|
0.00%
0/98
|
|
Infections and infestations
cellulitis
|
0.00%
0/97
|
1.0%
1/98
|
|
Infections and infestations
infusion site cellulitis
|
1.0%
1/97
|
0.00%
0/98
|
|
Infections and infestations
peritonitis bacterial
|
1.0%
1/97
|
0.00%
0/98
|
|
Infections and infestations
pneumonia
|
0.00%
0/97
|
1.0%
1/98
|
|
Investigations
ALT increased
|
0.00%
0/97
|
1.0%
1/98
|
|
Investigations
AST increased
|
0.00%
0/97
|
1.0%
1/98
|
|
Investigations
blood creatinine increased
|
0.00%
0/97
|
1.0%
1/98
|
|
Investigations
blood urea increased
|
0.00%
0/97
|
1.0%
1/98
|
|
Investigations
INR increased
|
1.0%
1/97
|
0.00%
0/98
|
|
Metabolism and nutrition disorders
decreased apetite
|
3.1%
3/97
|
4.1%
4/98
|
|
Metabolism and nutrition disorders
dehydration
|
2.1%
2/97
|
2.0%
2/98
|
|
Metabolism and nutrition disorders
failure to thrive
|
1.0%
1/97
|
0.00%
0/98
|
|
Metabolism and nutrition disorders
hyperglycemia
|
3.1%
3/97
|
0.00%
0/98
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.00%
0/97
|
1.0%
1/98
|
|
Metabolism and nutrition disorders
hypocalcemia
|
0.00%
0/97
|
1.0%
1/98
|
|
Metabolism and nutrition disorders
hypokalemia
|
1.0%
1/97
|
3.1%
3/98
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
0.00%
0/97
|
1.0%
1/98
|
|
Metabolism and nutrition disorders
hyponatremia
|
2.1%
2/97
|
1.0%
1/98
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/97
|
1.0%
1/98
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/97
|
3.1%
3/98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant neoplasm progression
|
0.00%
0/97
|
1.0%
1/98
|
|
Nervous system disorders
headache
|
1.0%
1/97
|
0.00%
0/98
|
|
Nervous system disorders
hemorrhagic stroke
|
0.00%
0/97
|
1.0%
1/98
|
|
Nervous system disorders
ischemic stroke
|
0.00%
0/97
|
1.0%
1/98
|
|
Nervous system disorders
syncope
|
0.00%
0/97
|
1.0%
1/98
|
|
Psychiatric disorders
depressed mood
|
0.00%
0/97
|
1.0%
1/98
|
|
Psychiatric disorders
insomnia
|
1.0%
1/97
|
0.00%
0/98
|
|
Psychiatric disorders
psychotic disorder
|
1.0%
1/97
|
0.00%
0/98
|
|
Renal and urinary disorders
renal failure acute
|
0.00%
0/97
|
1.0%
1/98
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
3.1%
3/97
|
1.0%
1/98
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
0.00%
0/97
|
1.0%
1/98
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
0.00%
0/97
|
1.0%
1/98
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
1.0%
1/97
|
1.0%
1/98
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
1.0%
1/97
|
3.1%
3/98
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hemorrhage
|
1.0%
1/97
|
0.00%
0/98
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
1.0%
1/97
|
1.0%
1/98
|
|
Skin and subcutaneous tissue disorders
alopecia
|
1.0%
1/97
|
0.00%
0/98
|
|
Skin and subcutaneous tissue disorders
panniculitis
|
0.00%
0/97
|
1.0%
1/98
|
|
Vascular disorders
aortic thrombus
|
0.00%
0/97
|
1.0%
1/98
|
|
Vascular disorders
deep vein thrombosis
|
1.0%
1/97
|
1.0%
1/98
|
|
Vascular disorders
hypertension
|
0.00%
0/97
|
2.0%
2/98
|
Other adverse events
| Measure |
A CBP501 +Cisplatin + Pemetrexed
n=97 participants at risk
CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2
CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
1. CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
2. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
3. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
|
B Cisplatin + Pemetrexed
n=98 participants at risk
Cisplatin + Pemetrexed
Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
1. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
2. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
19.6%
19/97
|
27.6%
27/98
|
|
Blood and lymphatic system disorders
leukopenia
|
7.2%
7/97
|
8.2%
8/98
|
|
Blood and lymphatic system disorders
neutropenia
|
16.5%
16/97
|
12.2%
12/98
|
|
Eye disorders
lacrimation increased
|
6.2%
6/97
|
6.1%
6/98
|
|
Gastrointestinal disorders
constipation
|
16.5%
16/97
|
13.3%
13/98
|
|
Gastrointestinal disorders
diarrhea
|
9.3%
9/97
|
8.2%
8/98
|
|
Gastrointestinal disorders
dyspepsia
|
3.1%
3/97
|
6.1%
6/98
|
|
Gastrointestinal disorders
nausea
|
45.4%
44/97
|
41.8%
41/98
|
|
Gastrointestinal disorders
vomiting
|
24.7%
24/97
|
25.5%
25/98
|
|
General disorders
asthenia
|
15.5%
15/97
|
21.4%
21/98
|
|
General disorders
chest pain
|
7.2%
7/97
|
8.2%
8/98
|
|
General disorders
fatigue
|
21.6%
21/97
|
20.4%
20/98
|
|
General disorders
infusion related reaction
|
59.8%
58/97
|
0.00%
0/98
|
|
General disorders
mucosal inflamation
|
3.1%
3/97
|
6.1%
6/98
|
|
General disorders
oedema peripheral
|
6.2%
6/97
|
3.1%
3/98
|
|
General disorders
pyrexia
|
4.1%
4/97
|
6.1%
6/98
|
|
Investigations
blood creatinine increased
|
7.2%
7/97
|
11.2%
11/98
|
|
Investigations
cleatinine clearance decreased
|
6.2%
6/97
|
1.0%
1/98
|
|
Investigations
hemoglobin decreased
|
6.2%
6/97
|
2.0%
2/98
|
|
Investigations
weight decreased
|
5.2%
5/97
|
4.1%
4/98
|
|
Metabolism and nutrition disorders
decreased appetite
|
23.7%
23/97
|
19.4%
19/98
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
2.1%
2/97
|
5.1%
5/98
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
3.1%
3/97
|
5.1%
5/98
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
5.2%
5/97
|
2.0%
2/98
|
|
Musculoskeletal and connective tissue disorders
back pain
|
8.2%
8/97
|
8.2%
8/98
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
4.1%
4/97
|
5.1%
5/98
|
|
Nervous system disorders
dizziness
|
6.2%
6/97
|
5.1%
5/98
|
|
Nervous system disorders
headache
|
4.1%
4/97
|
10.2%
10/98
|
|
Nervous system disorders
neuropathy peripheral
|
9.3%
9/97
|
4.1%
4/98
|
|
Psychiatric disorders
insomnia
|
8.2%
8/97
|
7.1%
7/98
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
9.3%
9/97
|
11.2%
11/98
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
9.3%
9/97
|
4.1%
4/98
|
|
Skin and subcutaneous tissue disorders
alopecia
|
4.1%
4/97
|
8.2%
8/98
|
|
Skin and subcutaneous tissue disorders
rash
|
4.1%
4/97
|
5.1%
5/98
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place