Trial Outcomes & Findings for A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT01380769)
NCT ID: NCT01380769
Last Updated: 2020-05-28
Results Overview
Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
157 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2020-05-28
Participant Flow
The study was conducted from 04 Jul 2011 to 07 Oct 2014. A total of 24 medical clinics participated in the study.
Participant milestones
| Measure |
CRLX101 + BSC (Best Supportive Care)
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.
|
BSC (Best Supportive Care) Alone
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.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
57
|
|
Overall Study
COMPLETED
|
91
|
43
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
Reasons for withdrawal
| Measure |
CRLX101 + BSC (Best Supportive Care)
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.
|
BSC (Best Supportive Care) Alone
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
11
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
CRLX101 + BSC (Best Supportive Care)
n=97 Participants
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.
|
BSC (Best Supportive Care) Alone
n=50 Participants
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
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 Years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
60.6 Years
STANDARD_DEVIATION 6.42 • n=7 Participants
|
59.4 Years
STANDARD_DEVIATION 7.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
56 participants
n=5 Participants
|
29 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
41 participants
n=5 Participants
|
21 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: 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)
Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.
Outcome measures
| Measure |
CRLX101
n=97 Participants
CRLX101: CRLX101 is administered at 15mg/m2 IV every other week
|
Best Supportive Care
n=50 Participants
Best Supportive Care: best supportive care
|
|---|---|---|
|
To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only
|
6.3 months
Interval 4.7 to 8.68
|
11.9 months
Interval 6.74 to
Insufficient data to estimate
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-To-Treat (ITT)
Comparison of objective response rate in subjects treated with CRLX101+BSC versus subjects treated with BSC alone.
Outcome measures
| Measure |
CRLX101
n=97 Participants
CRLX101: CRLX101 is administered at 15mg/m2 IV every other week
|
Best Supportive Care
n=50 Participants
Best Supportive Care: best supportive care
|
|---|---|---|
|
Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only
|
6.2 Percentage of Participants
|
2.0 Percentage of Participants
|
Adverse Events
CRLX101+BSC
Serious events: 12 serious events
Other events: 76 other events
Deaths: 0 deaths
Best Supportive Care (BSC) Only
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CRLX101+BSC
n=97 participants at risk
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.
|
Best Supportive Care (BSC) Only
n=50 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
atrial flutter
|
1.0%
1/97 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Cardiac disorders
cardiopulmonary failure
|
1.0%
1/97 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
4.0%
2/50 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
dysphagia
|
1.0%
1/97 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Immune system disorders
anaphylatic reaction
|
0.00%
0/97 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
|
Infections and infestations
bronchitis
|
2.1%
2/97 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Infections and infestations
lung abscess
|
0.00%
0/97 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
|
Infections and infestations
pyothorax
|
1.0%
1/97 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Investigations
liver function test
|
1.0%
1/97 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Psychiatric disorders
psychotic disorder
|
1.0%
1/97 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
hematuria
|
1.0%
1/97 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
esophagobronchial fistula
|
1.0%
1/97 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.00%
0/97 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hemorrhage
|
1.0%
1/97 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary thrombosis
|
1.0%
1/97 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Vascular disorders
superior vena cava syndrome
|
1.0%
1/97 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
Other adverse events
| Measure |
CRLX101+BSC
n=97 participants at risk
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.
|
Best Supportive Care (BSC) Only
n=50 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
17.5%
17/97 • Number of events 19 • First dose to 30 days after the last dose of study drug
|
28.0%
14/50 • Number of events 14 • First dose to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
14.4%
14/97 • Number of events 14 • First dose to 30 days after the last dose of study drug
|
20.0%
10/50 • Number of events 11 • First dose to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
7.2%
7/97 • Number of events 10 • First dose to 30 days after the last dose of study drug
|
18.0%
9/50 • Number of events 10 • First dose to 30 days after the last dose of study drug
|
|
General disorders
asthenia
|
12.4%
12/97 • Number of events 12 • First dose to 30 days after the last dose of study drug
|
18.0%
9/50 • Number of events 9 • First dose to 30 days after the last dose of study drug
|
|
General disorders
fatigue
|
10.3%
10/97 • Number of events 13 • First dose to 30 days after the last dose of study drug
|
8.0%
4/50 • Number of events 4 • First dose to 30 days after the last dose of study drug
|
|
General disorders
chest pain
|
8.2%
8/97 • Number of events 8 • First dose to 30 days after the last dose of study drug
|
16.0%
8/50 • Number of events 8 • First dose to 30 days after the last dose of study drug
|
|
General disorders
pyrexia
|
5.2%
5/97 • Number of events 8 • First dose to 30 days after the last dose of study drug
|
10.0%
5/50 • Number of events 9 • First dose to 30 days after the last dose of study drug
|
|
General disorders
pain
|
3.1%
3/97 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
|
General disorders
edema peripheral
|
3.1%
3/97 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
anemia
|
25.8%
25/97 • Number of events 46 • First dose to 30 days after the last dose of study drug
|
22.0%
11/50 • Number of events 12 • First dose to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
5.2%
5/97 • Number of events 18 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
neutropenia
|
4.1%
4/97 • Number of events 12 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
leukopenia
|
3.1%
3/97 • Number of events 4 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Investigations
alanine aminotransferase increased
|
8.2%
8/97 • Number of events 11 • First dose to 30 days after the last dose of study drug
|
6.0%
3/50 • Number of events 8 • First dose to 30 days after the last dose of study drug
|
|
Investigations
aspartate aminotransferase increased
|
8.2%
8/97 • Number of events 14 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 4 • First dose to 30 days after the last dose of study drug
|
|
Investigations
blood creatinine increased
|
5.2%
5/97 • Number of events 22 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
|
Investigations
blood alkaline phosphatase increased
|
3.1%
3/97 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
4.0%
2/50 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
|
Investigations
blood glucose increased
|
0.00%
0/97 • First dose to 30 days after the last dose of study drug
|
4.0%
2/50 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
0.00%
0/97 • First dose to 30 days after the last dose of study drug
|
4.0%
2/50 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
cystitis
|
10.3%
10/97 • Number of events 13 • First dose to 30 days after the last dose of study drug
|
4.0%
2/50 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
hematuria
|
7.2%
7/97 • Number of events 9 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 4 • First dose to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
leukocyturia
|
5.2%
5/97 • Number of events 8 • First dose to 30 days after the last dose of study drug
|
6.0%
3/50 • Number of events 5 • First dose to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
proteinuria
|
2.1%
2/97 • Number of events 4 • First dose to 30 days after the last dose of study drug
|
4.0%
2/50 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
nausea
|
11.3%
11/97 • Number of events 19 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
vomiting
|
3.1%
3/97 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
diarrhea
|
3.1%
3/97 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
4.1%
4/97 • Number of events 5 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
4.1%
4/97 • Number of events 5 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
back pain
|
3.1%
3/97 • Number of events 4 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
3.1%
3/97 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
|
Infections and infestations
pneumonia
|
4.1%
4/97 • Number of events 5 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Infections and infestations
respiratory tract infection
|
2.1%
2/97 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
6.0%
3/50 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
|
Cardiac disorders
sinus tachycardia
|
0.00%
0/97 • First dose to 30 days after the last dose of study drug
|
4.0%
2/50 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
decreased appetitie
|
4.1%
4/97 • Number of events 5 • First dose to 30 days after the last dose of study drug
|
4.0%
2/50 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
hyperglycemia
|
3.1%
3/97 • Number of events 5 • First dose to 30 days after the last dose of study drug
|
4.0%
2/50 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
|
Nervous system disorders
headache
|
2.1%
2/97 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
6.0%
3/50 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
|
Nervous system disorders
dizziness
|
1.0%
1/97 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
6.0%
3/50 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
|
Vascular disorders
superior vena cava syndrome
|
3.1%
3/97 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Vascular disorders
hypertension
|
3.1%
3/97 • Number of events 4 • First dose to 30 days after the last dose of study drug
|
2.0%
1/50 • Number of events 1 • First dose to 30 days after the last dose of study drug
|
|
Hepatobiliary disorders
hyperbilirubinemia
|
3.1%
3/97 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
4.0%
2/50 • Number of events 5 • First dose to 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
alopecia
|
3.1%
3/97 • Number of events 3 • First dose to 30 days after the last dose of study drug
|
0.00%
0/50 • First dose to 30 days after the last dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
non-small cell lung cancer
|
0.00%
0/97 • First dose to 30 days after the last dose of study drug
|
4.0%
2/50 • Number of events 2 • First dose to 30 days after the last dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER