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Triplet Combination First Line Treatment in Non Small Cell Lung Cancer (NSCLC) (CBP08-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00942825
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
CanBas Co. Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Non-squamous Non Small Cell Lung Cancer
Interventions Drug: CBP501 + Cisplatin + Pemetrexed
Drug: Cisplatin + Pemetrexed
Enrollment 195
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A CBP501 +Cisplatin + Pemetrexed B Cisplatin + Pemetrexed
Hide Arm/Group Description

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.

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.
Period Title: Overall Study
Started 97 98
Completed 97 98
Not Completed 0 0
Arm/Group Title A CBP501 +Cisplatin + Pemetrexed B Cisplatin + Pemetrexed Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 97 98 195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 98 participants 195 participants
60.5  (8.66) 60.6  (9.03) 60.6  (8.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 98 participants 195 participants
Female
51
  52.6%
36
  36.7%
87
  44.6%
Male
46
  47.4%
62
  63.3%
108
  55.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 98 participants 195 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
   6.2%
1
   1.0%
7
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   3.1%
3
   3.1%
6
   3.1%
White
75
  77.3%
88
  89.8%
163
  83.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
13
  13.4%
6
   6.1%
19
   9.7%
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 15 June 2009 to 30 September 2012
Hide Outcome Measure Data
Hide Analysis Population Description
Treated population
Arm/Group Title A CBP501 +Cisplatin + Pemetrexed B Cisplatin + Pemetrexed
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 97 98
Median (95% Confidence Interval)
Unit of Measure: days
140
(107 to 171)
165
(132 to 186)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A CBP501 +Cisplatin + Pemetrexed B Cisplatin + Pemetrexed
Hide Arm/Group Description

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.

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.
All-Cause Mortality
A CBP501 +Cisplatin + Pemetrexed B Cisplatin + Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
A CBP501 +Cisplatin + Pemetrexed B Cisplatin + Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   37/97 (38.14%)   38/98 (38.78%) 
Blood and lymphatic system disorders     
anemia   11/97 (11.34%)  11/98 (11.22%) 
febrile neutropenia   1/97 (1.03%)  1/98 (1.02%) 
leukopenia   1/97 (1.03%)  4/98 (4.08%) 
neutropenia   9/97 (9.28%)  9/98 (9.18%) 
pancytopenia   1/97 (1.03%)  0/98 (0.00%) 
thrombocytopenia   2/97 (2.06%)  2/98 (2.04%) 
Cardiac disorders     
atrial flutter   0/97 (0.00%)  1/98 (1.02%) 
cadiac arrest   1/97 (1.03%)  0/98 (0.00%) 
Gastrointestinal disorders     
diarrhea   1/97 (1.03%)  1/98 (1.02%) 
GI hemorrage   1/97 (1.03%)  0/98 (0.00%) 
nausea   1/97 (1.03%)  3/98 (3.06%) 
peritonitis   1/97 (1.03%)  0/98 (0.00%) 
retching   1/97 (1.03%)  0/98 (0.00%) 
upper GI hemorrage   1/97 (1.03%)  0/98 (0.00%) 
vomiting   1/97 (1.03%)  2/98 (2.04%) 
General disorders     
asthenia   4/97 (4.12%)  1/98 (1.02%) 
fatigue   2/97 (2.06%)  5/98 (5.10%) 
infusion related reaction   1/97 (1.03%)  0/98 (0.00%) 
infusion site reaction   1/97 (1.03%)  0/98 (0.00%) 
malaise   1/97 (1.03%)  0/98 (0.00%) 
Immune system disorders     
hypersensitivity   1/97 (1.03%)  0/98 (0.00%) 
Infections and infestations     
cellulitis   0/97 (0.00%)  1/98 (1.02%) 
infusion site cellulitis   1/97 (1.03%)  0/98 (0.00%) 
peritonitis bacterial   1/97 (1.03%)  0/98 (0.00%) 
pneumonia   0/97 (0.00%)  1/98 (1.02%) 
Investigations     
ALT increased   0/97 (0.00%)  1/98 (1.02%) 
AST increased   0/97 (0.00%)  1/98 (1.02%) 
blood creatinine increased   0/97 (0.00%)  1/98 (1.02%) 
blood urea increased   0/97 (0.00%)  1/98 (1.02%) 
INR increased   1/97 (1.03%)  0/98 (0.00%) 
Metabolism and nutrition disorders     
decreased apetite   3/97 (3.09%)  4/98 (4.08%) 
dehydration   2/97 (2.06%)  2/98 (2.04%) 
failure to thrive   1/97 (1.03%)  0/98 (0.00%) 
hyperglycemia   3/97 (3.09%)  0/98 (0.00%) 
hyperkalemia   0/97 (0.00%)  1/98 (1.02%) 
hypocalcemia   0/97 (0.00%)  1/98 (1.02%) 
hypokalemia   1/97 (1.03%)  3/98 (3.06%) 
hypomagnesemia   0/97 (0.00%)  1/98 (1.02%) 
hyponatremia   2/97 (2.06%)  1/98 (1.02%) 
Musculoskeletal and connective tissue disorders     
arthralgia   0/97 (0.00%)  1/98 (1.02%) 
back pain   0/97 (0.00%)  3/98 (3.06%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
malignant neoplasm progression   0/97 (0.00%)  1/98 (1.02%) 
Nervous system disorders     
headache   1/97 (1.03%)  0/98 (0.00%) 
hemorrhagic stroke   0/97 (0.00%)  1/98 (1.02%) 
ischemic stroke   0/97 (0.00%)  1/98 (1.02%) 
syncope   0/97 (0.00%)  1/98 (1.02%) 
Psychiatric disorders     
depressed mood   0/97 (0.00%)  1/98 (1.02%) 
insomnia   1/97 (1.03%)  0/98 (0.00%) 
psychotic disorder   1/97 (1.03%)  0/98 (0.00%) 
Renal and urinary disorders     
renal failure acute   0/97 (0.00%)  1/98 (1.02%) 
Respiratory, thoracic and mediastinal disorders     
dyspnea   3/97 (3.09%)  1/98 (1.02%) 
hemoptysis   0/97 (0.00%)  1/98 (1.02%) 
hiccups   0/97 (0.00%)  1/98 (1.02%) 
pleural effusion   1/97 (1.03%)  1/98 (1.02%) 
pulmonary embolism   1/97 (1.03%)  3/98 (3.06%) 
pulmonary hemorrhage   1/97 (1.03%)  0/98 (0.00%) 
respiratory failure   1/97 (1.03%)  1/98 (1.02%) 
Skin and subcutaneous tissue disorders     
alopecia   1/97 (1.03%)  0/98 (0.00%) 
panniculitis   0/97 (0.00%)  1/98 (1.02%) 
Vascular disorders     
aortic thrombus   0/97 (0.00%)  1/98 (1.02%) 
deep vein thrombosis   1/97 (1.03%)  1/98 (1.02%) 
hypertension   0/97 (0.00%)  2/98 (2.04%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A CBP501 +Cisplatin + Pemetrexed B Cisplatin + Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   58/97 (59.79%)   53/98 (54.08%) 
Blood and lymphatic system disorders     
anemia   19/97 (19.59%)  27/98 (27.55%) 
leukopenia   7/97 (7.22%)  8/98 (8.16%) 
neutropenia   16/97 (16.49%)  12/98 (12.24%) 
Eye disorders     
lacrimation increased   6/97 (6.19%)  6/98 (6.12%) 
Gastrointestinal disorders     
constipation   16/97 (16.49%)  13/98 (13.27%) 
diarrhea   9/97 (9.28%)  8/98 (8.16%) 
dyspepsia   3/97 (3.09%)  6/98 (6.12%) 
nausea   44/97 (45.36%)  41/98 (41.84%) 
vomiting   24/97 (24.74%)  25/98 (25.51%) 
General disorders     
asthenia   15/97 (15.46%)  21/98 (21.43%) 
chest pain   7/97 (7.22%)  8/98 (8.16%) 
fatigue   21/97 (21.65%)  20/98 (20.41%) 
infusion related reaction   58/97 (59.79%)  0/98 (0.00%) 
mucosal inflamation   3/97 (3.09%)  6/98 (6.12%) 
oedema peripheral   6/97 (6.19%)  3/98 (3.06%) 
pyrexia   4/97 (4.12%)  6/98 (6.12%) 
Investigations     
blood creatinine increased   7/97 (7.22%)  11/98 (11.22%) 
cleatinine clearance decreased   6/97 (6.19%)  1/98 (1.02%) 
hemoglobin decreased   6/97 (6.19%)  2/98 (2.04%) 
weight decreased   5/97 (5.15%)  4/98 (4.08%) 
Metabolism and nutrition disorders     
decreased appetite   23/97 (23.71%)  19/98 (19.39%) 
hypoalbuminemia   2/97 (2.06%)  5/98 (5.10%) 
hypomagnesemia   3/97 (3.09%)  5/98 (5.10%) 
Musculoskeletal and connective tissue disorders     
arthralgia   5/97 (5.15%)  2/98 (2.04%) 
back pain   8/97 (8.25%)  8/98 (8.16%) 
pain in extremity   4/97 (4.12%)  5/98 (5.10%) 
Nervous system disorders     
dizziness   6/97 (6.19%)  5/98 (5.10%) 
headache   4/97 (4.12%)  10/98 (10.20%) 
neuropathy peripheral   9/97 (9.28%)  4/98 (4.08%) 
Psychiatric disorders     
insomnia   8/97 (8.25%)  7/98 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
cough   9/97 (9.28%)  11/98 (11.22%) 
dyspnea   9/97 (9.28%)  4/98 (4.08%) 
Skin and subcutaneous tissue disorders     
alopecia   4/97 (4.12%)  8/98 (8.16%) 
rash   4/97 (4.12%)  5/98 (5.10%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Takumi Kawabe, MD, PhD
Organization: CanBas Co., Ltd.
Phone: 81559543666
EMail: takumi@canbas.co.jp
Publications:
Layout table for additonal information
Responsible Party: CanBas Co. Ltd.
ClinicalTrials.gov Identifier: NCT00942825    
Other Study ID Numbers: CBP08-02
First Submitted: July 17, 2009
First Posted: July 21, 2009
Results First Submitted: March 14, 2017
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017