Trial Outcomes & Findings for Clinical Trial of the Safety and Efficacy of the Addition of Ramucirumab to Nab-paclitaxel in Previously Treated Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (NCT NCT02730247)
NCT ID: NCT02730247
Last Updated: 2020-11-19
Results Overview
The duration of time from start of treatment to time of progression or death. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
COMPLETED
PHASE2
7 participants
Up to 26 months
2020-11-19
Participant Flow
Participant milestones
| Measure |
Ramucirumab + Nab-paclitaxel
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of the Safety and Efficacy of the Addition of Ramucirumab to Nab-paclitaxel in Previously Treated Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Ramucirumab + Nab-paclitaxel
n=7 Participants
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Stage of Disease
Stage IV
|
5 Participants
n=93 Participants
|
|
Stage of Disease
Stage IV B
|
2 Participants
n=93 Participants
|
|
ECOG Performance Status
Grade 1
|
6 Participants
n=93 Participants
|
|
ECOG Performance Status
Grade 2
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
63 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 26 monthsPopulation: Patients evaluable for clinical response who have received at least one cycle of therapy.
The duration of time from start of treatment to time of progression or death. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Ramucirumab + Nab-paclitaxel
n=7 Participants
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Progression-free Survival (PFS)
|
8.16 months
Interval 3.68 to
Upper bound not able to be reached due to low patient accrual.
|
PRIMARY outcome
Timeframe: Up to 26 monthsPopulation: Patients that received at least one dose of study treatment.
Percentage of patients that experienced Grade 3-5 adverse events as their highest Grade event, irrespective of relatedness to treatment, per NCI CTCAE v2.0 (National Cancer Institute Common Terminology Criteria for Adverse Events).
Outcome measures
| Measure |
Ramucirumab + Nab-paclitaxel
n=7 Participants
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Worst Grade of Adverse Event Experienced
Grade 3 adverse event
|
57.1 percentage of participants
Interval 20.0 to 87.6
|
|
Worst Grade of Adverse Event Experienced
Grade 4 adverse event
|
28.6 percentage of participants
Interval 6.2 to 70.7
|
|
Worst Grade of Adverse Event Experienced
Grade 5 adverse event
|
14.3 percentage of participants
Interval 1.8 to 59.7
|
PRIMARY outcome
Timeframe: Up to 26 monthsPopulation: Patients that received at least one dose of study treatment.
Percentage of patients who experienced Grade 2-5 adverse events as their highest Grade event, that were at least possibly related to treatment, per NCI CTCAE v2.0 (National Cancer Institute Common Terminology Criteria for Adverse Events).
Outcome measures
| Measure |
Ramucirumab + Nab-paclitaxel
n=7 Participants
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Worst Grade of Adverse Event Experienced, at Least Possibly Related to Treatment
Grade 2
|
14.3 percentage of participants
Interval 1.5 to 64.8
|
|
Worst Grade of Adverse Event Experienced, at Least Possibly Related to Treatment
Grade 3
|
42.9 percentage of participants
Interval 10.5 to 82.8
|
|
Worst Grade of Adverse Event Experienced, at Least Possibly Related to Treatment
Grade 4
|
28.6 percentage of participants
Interval 5.2 to 74.6
|
|
Worst Grade of Adverse Event Experienced, at Least Possibly Related to Treatment
Grade 5
|
14.3 percentage of participants
Interval 1.5 to 64.8
|
PRIMARY outcome
Timeframe: Up to 26 monthsPopulation: Patients that received at least one dose of study treatment.
Percentage of patients who experienced Grade 0-4 adverse events as their highest Grade event, that were at least probably related to treatment, per NCI CTCAE v2.0 (National Cancer Institute Common Terminology Criteria for Adverse Events).
Outcome measures
| Measure |
Ramucirumab + Nab-paclitaxel
n=7 Participants
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Worst Grade of Adverse Event Experienced, at Least Probably Related to Treatment
Grade 0
|
14.3 percentage of participants
Interval 1.3 to 68.4
|
|
Worst Grade of Adverse Event Experienced, at Least Probably Related to Treatment
Grade 1
|
28.6 percentage of participants
Interval 4.5 to 77.3
|
|
Worst Grade of Adverse Event Experienced, at Least Probably Related to Treatment
Grade 2
|
28.6 percentage of participants
Interval 4.5 to 77.3
|
|
Worst Grade of Adverse Event Experienced, at Least Probably Related to Treatment
Grade 3
|
14.3 percentage of participants
Interval 1.3 to 68.4
|
|
Worst Grade of Adverse Event Experienced, at Least Probably Related to Treatment
Grade 4
|
14.3 percentage of participants
Interval 1.3 to 68.4
|
PRIMARY outcome
Timeframe: Up to 26 monthsPopulation: Patients that received at least one dose of study treatment.
Percentage of patients that experienced Grade 0-2 adverse events as their highest Grade event, that were definitely related to treatment, per NCI CTCAE v2.0 (National Cancer Institute Common Terminology Criteria for Adverse Events.
Outcome measures
| Measure |
Ramucirumab + Nab-paclitaxel
n=7 Participants
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Worst Grade of Adverse Event Experienced, Definitely Related to Treatment
Grade 0
|
71.4 proportion of participants
Interval 29.3 to 93.8
|
|
Worst Grade of Adverse Event Experienced, Definitely Related to Treatment
Grade 1
|
14.3 proportion of participants
Interval 1.8 to 59.7
|
|
Worst Grade of Adverse Event Experienced, Definitely Related to Treatment
Grade 2
|
14.3 proportion of participants
Interval 1.8 to 59.7
|
SECONDARY outcome
Timeframe: Up to 26 monthsPopulation: Patients evaluable for response who received at least one cycle of therapy.
Median percentage of patients who experienced a best response of partial or complete response (PR + CR) / total number of patients (PR + CR + Stable Disease (SD) + Progressive Disease (PD)), per RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm; appearance new lesions.
Outcome measures
| Measure |
Ramucirumab + Nab-paclitaxel
n=6 Participants
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Best Overall Response
Best Response - Stable Disease
|
67.7 percentage of participants
Interval 22.3 to 95.7
|
|
Best Overall Response
Best Response - Partial Response
|
33.3 percentage of participants
Interval 4.3 to 77.8
|
SECONDARY outcome
Timeframe: Up to 26 monthsPopulation: All enrolled participants.
The duration of time from the start of treatment to death.
Outcome measures
| Measure |
Ramucirumab + Nab-paclitaxel
n=7 Participants
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Overall Survival (OS)
|
7.42 months
Interval 3.48 to
Upper bound not able to be reached due to low patient accrual.
|
SECONDARY outcome
Timeframe: Baseline through up to 26 monthsPopulation: Patients that received at least one dose of study treatment and who completed at least one questionnaire.
The EuroQol Five Dimension questionnaire (EQ-5D-5L) score is a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: level 0=no problems, level 1=slight problems, level 2=moderate problems, level 3=severe problems and level 4= extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Data is presented as a health profile table reporting a proportion of reported problems for each level for each dimension and/or dichotomised levels - 'no problems' (i.e. level 1) and 'problems' (i.e. levels 2 to 5)
Outcome measures
| Measure |
Ramucirumab + Nab-paclitaxel
n=7 Participants
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Median EuroQol Five Dimension Questionnaire (EQ-5D-5L) Score
Walking
|
1 EQ-5D-5L score
Interval 0.0 to 2.0
|
|
Median EuroQol Five Dimension Questionnaire (EQ-5D-5L) Score
Dressing
|
1 EQ-5D-5L score
Interval 0.0 to 2.0
|
|
Median EuroQol Five Dimension Questionnaire (EQ-5D-5L) Score
Active
|
1 EQ-5D-5L score
Interval 0.0 to 4.0
|
|
Median EuroQol Five Dimension Questionnaire (EQ-5D-5L) Score
Pain
|
1 EQ-5D-5L score
Interval 0.0 to 4.0
|
|
Median EuroQol Five Dimension Questionnaire (EQ-5D-5L) Score
Anxious
|
1 EQ-5D-5L score
Interval 0.0 to 3.0
|
Adverse Events
Ramucirumab + Nab-paclitaxel
Serious adverse events
| Measure |
Ramucirumab + Nab-paclitaxel
n=7 participants at risk
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Number of events 4 • Up to 26 months
|
|
Cardiac disorders
Cardiac arrest
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
2/7 • Number of events 8 • Up to 26 months
|
|
Investigations
Lymphocyte count decreased
|
42.9%
3/7 • Number of events 16 • Up to 26 months
|
|
Investigations
Neutrophil count decreased
|
42.9%
3/7 • Number of events 24 • Up to 26 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Nervous system disorders
Syncope
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Vascular disorders
Thromboembolic event
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Investigations
Weight loss
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Investigations
White blood cell decreased
|
28.6%
2/7 • Number of events 16 • Up to 26 months
|
Other adverse events
| Measure |
Ramucirumab + Nab-paclitaxel
n=7 participants at risk
8 mg/kg IV ramucirumab on days 1 and 15 of a 28-day treatment cycle
100 mg/m\^2 IV nab-paclitaxel on days 1, 8 and 15 of a 28 day cycle
|
|---|---|
|
Investigations
Alkaline phosphatase increased
|
42.9%
3/7 • Number of events 14 • Up to 26 months
|
|
Blood and lymphatic system disorders
Anemia
|
85.7%
6/7 • Number of events 56 • Up to 26 months
|
|
Metabolism and nutrition disorders
Anorexia
|
57.1%
4/7 • Number of events 8 • Up to 26 months
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Injury, poisoning and procedural complications
Arterial injury
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Investigations
Aspartate aminotransferase increased
|
42.9%
3/7 • Number of events 20 • Up to 26 months
|
|
Investigations
Blood bilirubin increased
|
28.6%
2/7 • Number of events 14 • Up to 26 months
|
|
Cardiac disorders
Cardiac arrest
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Number of events 4 • Up to 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Investigations
Creatinine increased
|
14.3%
1/7 • Number of events 6 • Up to 26 months
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Number of events 4 • Up to 26 months
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 8 • Up to 26 months
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
57.1%
4/7 • Number of events 12 • Up to 26 months
|
|
General disorders
Edema limbs
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Eye disorders
Eye disorders - Other, specify
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
General disorders
Fatigue
|
71.4%
5/7 • Number of events 16 • Up to 26 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
General disorders
Gait disturbance
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
14.3%
1/7 • Number of events 4 • Up to 26 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
28.6%
2/7 • Number of events 4 • Up to 26 months
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Number of events 4 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.9%
3/7 • Number of events 30 • Up to 26 months
|
|
Vascular disorders
Hypertension
|
28.6%
2/7 • Number of events 8 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
71.4%
5/7 • Number of events 48 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
2/7 • Number of events 16 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
28.6%
2/7 • Number of events 4 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
42.9%
3/7 • Number of events 10 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
85.7%
6/7 • Number of events 36 • Up to 26 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
57.1%
4/7 • Number of events 14 • Up to 26 months
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 4 • Up to 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Investigations
INR increased
|
14.3%
1/7 • Number of events 4 • Up to 26 months
|
|
Investigations
Investigations - Other, specify
|
42.9%
3/7 • Number of events 14 • Up to 26 months
|
|
Investigations
Lymphocyte count decreased
|
42.9%
3/7 • Number of events 30 • Up to 26 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
28.6%
2/7 • Number of events 10 • Up to 26 months
|
|
Infections and infestations
Mucosal infection
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
2/7 • Number of events 4 • Up to 26 months
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Investigations
Neutrophil count decreased
|
71.4%
5/7 • Number of events 84 • Up to 26 months
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 4 • Up to 26 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.6%
2/7 • Number of events 4 • Up to 26 months
|
|
Investigations
Platelet count decreased
|
42.9%
3/7 • Number of events 22 • Up to 26 months
|
|
Renal and urinary disorders
Proteinuria
|
57.1%
4/7 • Number of events 8 • Up to 26 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Cardiac disorders
Sinus tachycardia
|
28.6%
2/7 • Number of events 8 • Up to 26 months
|
|
Infections and infestations
Skin infection
|
28.6%
2/7 • Number of events 4 • Up to 26 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Nervous system disorders
Syncope
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Vascular disorders
Thromboembolic event
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
14.3%
1/7 • Number of events 4 • Up to 26 months
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Renal and urinary disorders
Urinary frequency
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 2 • Up to 26 months
|
|
Investigations
Weight loss
|
28.6%
2/7 • Number of events 6 • Up to 26 months
|
|
Investigations
White blood cell decreased
|
57.1%
4/7 • Number of events 68 • Up to 26 months
|
Additional Information
Barbara Stadterman, MPH, MCCR; CRS Regulatory Supervisor
UPMC Hillman Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place