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A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer

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: NCT01380769
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : May 24, 2017
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Lumos Pharma ( NewLink Genetics Corporation )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: CRLX101
Other: Best Supportive Care
Enrollment 157
Recruitment Details The study was conducted from 04 Jul 2011 to 07 Oct 2014. A total of 24 medical clinics participated in the study.
Pre-assignment Details  
Arm/Group Title CRLX101 + BSC (Best Supportive Care) BSC (Best Supportive Care) Alone
Hide Arm/Group Description 15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required. Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
Period Title: Overall Study
Started 100 57
Completed 91 [1] 43 [1]
Not Completed 9 14
Reason Not Completed
Withdrawal by Subject             7             11
Physician Decision             1             1
Adverse Event             1             1
Protocol Violation             0             1
[1]
subjects in ITT with reported date of death, alive with progression, or alive without progression
Arm/Group Title CRLX101 + BSC (Best Supportive Care) BSC (Best Supportive Care) Alone Total
Hide Arm/Group Description 15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required. Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required. Total of all reporting groups
Overall Number of Baseline Participants 97 50 147
Hide Baseline Analysis Population Description
Intention-to-treat (ITT) and Patient Safety Population (PSP), includes all CRLX101 + BSC subjects who received at least 1 dose of study treatment and all randomized BSC alone subjects who attended at least 1 study visit.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 50 participants 147 participants
58  (8.22) 60.6  (6.42) 59.4  (7.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 50 participants 147 participants
Female
25
  25.8%
17
  34.0%
42
  28.6%
Male
72
  74.2%
33
  66.0%
105
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 97 participants 50 participants 147 participants
Russian Federation 56 29 85
Ukraine 41 21 62
1.Primary Outcome
Title To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only
Hide Description Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) and Patient Safety Population (PSP), includes all CRLX101 + BSC subjects who received at least 1 dose of study treatment and all randomized BSC alone subjects who attended at least 1 study visit. (Confidence interval if insufficient data to estimate NE = 99999.99)
Arm/Group Title CRLX101 Best Supportive Care
Hide Arm/Group Description:
CRLX101: CRLX101 is administered at 15mg/m2 IV every other week
Best Supportive Care: best supportive care
Overall Number of Participants Analyzed 97 50
Median (95% Confidence Interval)
Unit of Measure: months
6.3
(4.70 to 8.68)
11.9 [1] 
(6.74 to NA)
[1]
Insufficient data to estimate
2.Secondary Outcome
Title Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only
Hide Description Comparison of objective response rate in subjects treated with CRLX101+BSC versus subjects treated with BSC alone.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT)
Arm/Group Title CRLX101 Best Supportive Care
Hide Arm/Group Description:
CRLX101: CRLX101 is administered at 15mg/m2 IV every other week
Best Supportive Care: best supportive care
Overall Number of Participants Analyzed 97 50
Measure Type: Number
Unit of Measure: Percentage of Participants
6.2 2.0
Time Frame First dose to 30 days after the last dose of study drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CRLX101+BSC Best Supportive Care (BSC) Only
Hide Arm/Group Description 15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required. Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
All-Cause Mortality
CRLX101+BSC Best Supportive Care (BSC) Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
CRLX101+BSC Best Supportive Care (BSC) Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/97 (12.37%)      5/50 (10.00%)    
Cardiac disorders     
atrial flutter * 1  1/97 (1.03%)  1 0/50 (0.00%)  0
cardiopulmonary failure * 1  1/97 (1.03%)  1 2/50 (4.00%)  2
Gastrointestinal disorders     
dysphagia * 1  1/97 (1.03%)  1 0/50 (0.00%)  0
Immune system disorders     
anaphylatic reaction * 1  0/97 (0.00%)  0 1/50 (2.00%)  1
Infections and infestations     
bronchitis * 1  2/97 (2.06%)  2 0/50 (0.00%)  0
lung abscess * 1  0/97 (0.00%)  0 1/50 (2.00%)  1
pyothorax * 1  1/97 (1.03%)  1 0/50 (0.00%)  0
Investigations     
liver function test * 1  1/97 (1.03%)  1 0/50 (0.00%)  0
Psychiatric disorders     
psychotic disorder * 1  1/97 (1.03%)  1 0/50 (0.00%)  0
Renal and urinary disorders     
hematuria * 1  1/97 (1.03%)  1 0/50 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
esophagobronchial fistula * 1  1/97 (1.03%)  1 0/50 (0.00%)  0
pneumothorax * 1  0/97 (0.00%)  0 1/50 (2.00%)  1
pulmonary hemorrhage * 1  1/97 (1.03%)  1 0/50 (0.00%)  0
pulmonary thrombosis * 1  1/97 (1.03%)  1 0/50 (0.00%)  0
Vascular disorders     
superior vena cava syndrome * 1  1/97 (1.03%)  1 0/50 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, version 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
CRLX101+BSC Best Supportive Care (BSC) Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/97 (78.35%)      39/50 (78.00%)    
Blood and lymphatic system disorders     
anemia * 1  25/97 (25.77%)  46 11/50 (22.00%)  12
thrombocytopenia * 1  5/97 (5.15%)  18 0/50 (0.00%)  0
neutropenia * 1  4/97 (4.12%)  12 0/50 (0.00%)  0
leukopenia * 1  3/97 (3.09%)  4 0/50 (0.00%)  0
Cardiac disorders     
sinus tachycardia * 1  0/97 (0.00%)  0 2/50 (4.00%)  2
Gastrointestinal disorders     
nausea * 1  11/97 (11.34%)  19 1/50 (2.00%)  1
vomiting * 1  3/97 (3.09%)  3 1/50 (2.00%)  1
diarrhea * 1  3/97 (3.09%)  3 0/50 (0.00%)  0
General disorders     
asthenia * 1  12/97 (12.37%)  12 9/50 (18.00%)  9
fatigue * 1  10/97 (10.31%)  13 4/50 (8.00%)  4
chest pain * 1  8/97 (8.25%)  8 8/50 (16.00%)  8
pyrexia * 1  5/97 (5.15%)  8 5/50 (10.00%)  9
pain * 1  3/97 (3.09%)  3 1/50 (2.00%)  1
edema peripheral * 1  3/97 (3.09%)  3 0/50 (0.00%)  0
Hepatobiliary disorders     
hyperbilirubinemia * 1  3/97 (3.09%)  3 2/50 (4.00%)  5
Infections and infestations     
pneumonia * 1  4/97 (4.12%)  5 0/50 (0.00%)  0
respiratory tract infection * 1  2/97 (2.06%)  2 3/50 (6.00%)  3
Investigations     
alanine aminotransferase increased * 1  8/97 (8.25%)  11 3/50 (6.00%)  8
aspartate aminotransferase increased * 1  8/97 (8.25%)  14 1/50 (2.00%)  4
blood creatinine increased * 1  5/97 (5.15%)  22 1/50 (2.00%)  1
blood alkaline phosphatase increased * 1  3/97 (3.09%)  3 2/50 (4.00%)  2
blood glucose increased * 1  0/97 (0.00%)  0 2/50 (4.00%)  2
Eastern Cooperative Oncology Group performance status worsened * 1  0/97 (0.00%)  0 2/50 (4.00%)  2
Metabolism and nutrition disorders     
decreased appetitie * 1  4/97 (4.12%)  5 2/50 (4.00%)  2
hyperglycemia * 1  3/97 (3.09%)  5 2/50 (4.00%)  2
Musculoskeletal and connective tissue disorders     
bone pain * 1  4/97 (4.12%)  5 0/50 (0.00%)  0
pain in extremity * 1  4/97 (4.12%)  5 0/50 (0.00%)  0
back pain * 1  3/97 (3.09%)  4 1/50 (2.00%)  1
neck pain * 1  3/97 (3.09%)  3 1/50 (2.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
non-small cell lung cancer * 1 [1]  0/97 (0.00%)  0 2/50 (4.00%)  2
Nervous system disorders     
headache * 1  2/97 (2.06%)  2 3/50 (6.00%)  3
dizziness * 1  1/97 (1.03%)  2 3/50 (6.00%)  3
Renal and urinary disorders     
cystitis * 1  10/97 (10.31%)  13 2/50 (4.00%)  3
hematuria * 1  7/97 (7.22%)  9 1/50 (2.00%)  4
leukocyturia * 1  5/97 (5.15%)  8 3/50 (6.00%)  5
proteinuria * 1  2/97 (2.06%)  4 2/50 (4.00%)  2
Respiratory, thoracic and mediastinal disorders     
dyspnea * 1  17/97 (17.53%)  19 14/50 (28.00%)  14
cough * 1  14/97 (14.43%)  14 10/50 (20.00%)  11
hemoptysis * 1  7/97 (7.22%)  10 9/50 (18.00%)  10
Skin and subcutaneous tissue disorders     
alopecia * 1  3/97 (3.09%)  3 0/50 (0.00%)  0
Vascular disorders     
superior vena cava syndrome * 1  3/97 (3.09%)  3 0/50 (0.00%)  0
hypertension * 1  3/97 (3.09%)  4 1/50 (2.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, version 16.0
[1]
progression of disease
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.
The Investigator interested in participating in writing the manuscript should contact the Sponsor. The Investigsator shall not make any Study-related publication or other disclosure without the Sponsor's prior written approval, which may be withheld or granted by the Sponsor, in its sole discretion.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adrian Senderowicz
Organization: Cerulean Pharma Inc.
Phone: 617 551 9600
EMail: asenderowicz@ceruleanrx.com
Layout table for additonal information
Responsible Party: Lumos Pharma ( NewLink Genetics Corporation )
ClinicalTrials.gov Identifier: NCT01380769    
Other Study ID Numbers: CRLX-002
First Submitted: June 22, 2011
First Posted: June 27, 2011
Results First Submitted: October 26, 2015
Results First Posted: May 24, 2017
Last Update Posted: May 28, 2020