Trial Outcomes & Findings for A Study of Nivolumab +/- Nab-paclitaxel in Non-small Cell Lung Cancer (NCT NCT02967133)
NCT ID: NCT02967133
Last Updated: 2022-09-08
Results Overview
This study will compare the progression-free survival of patients with advanced stage non-small cell lung cancer whose cancer has progressed after standard first-line platinum based doublet chemotherapy is improved with nivolumab plus nab-paclitaxel compared to nivolumab alone. A progression is defined as 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). 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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
13 months
Results posted on
2022-09-08
Participant Flow
Participant milestones
| Measure |
Arm A (Nivolumab Alone)
Nivolumab q 14 days until disease progression/toxicity Nivolumab: Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.
|
Arm B (Nivolumab + Nab-Paclitaxel)
Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days nab-paclitaxel: Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Nivolumab +/- Nab-paclitaxel in Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Nivolumab Alone)
n=3 Participants
Nivolumab q 14 days until disease progression/toxicity Nivolumab: Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.
|
Arm B (Nivolumab + Nab-Paclitaxel)
n=4 Participants
Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days nab-paclitaxel: Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
70.5 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 monthsThis study will compare the progression-free survival of patients with advanced stage non-small cell lung cancer whose cancer has progressed after standard first-line platinum based doublet chemotherapy is improved with nivolumab plus nab-paclitaxel compared to nivolumab alone. A progression is defined as 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). 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 |
Arm A (Nivolumab Alone)
n=3 Participants
Nivolumab q 14 days until disease progression/toxicity Nivolumab: Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.
|
Arm B (Nivolumab + Nab-Paclitaxel)
n=4 Participants
Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days nab-paclitaxel: Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.
|
|---|---|---|
|
Progression-Free Survival
|
1.3 Months
Interval 1.0 to
Insufficient number of participants with events
|
5.3 Months
Interval 1.3 to
Insufficient number of participants with events
|
Adverse Events
Arm A (Nivolumab Alone)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm B (Nivolumab + Nab-Paclitaxel)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A (Nivolumab Alone)
n=3 participants at risk
Nivolumab q 14 days until disease progression/toxicity Nivolumab: Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.
|
Arm B (Nivolumab + Nab-Paclitaxel)
n=4 participants at risk
Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days nab-paclitaxel: Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.
|
|---|---|---|
|
General disorders
Death NOS
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
Other adverse events
| Measure |
Arm A (Nivolumab Alone)
n=3 participants at risk
Nivolumab q 14 days until disease progression/toxicity Nivolumab: Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.
|
Arm B (Nivolumab + Nab-Paclitaxel)
n=4 participants at risk
Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days nab-paclitaxel: Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Cardiac disorders
Pericardial effusion
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 4 • 13 months
|
0.00%
0/4 • 13 months
|
|
Gastrointestinal disorders
Dry mouth
|
66.7%
2/3 • Number of events 2 • 13 months
|
0.00%
0/4 • 13 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 1 • 13 months
|
50.0%
2/4 • Number of events 3 • 13 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 2 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 5 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/3 • 13 months
|
50.0%
2/4 • Number of events 5 • 13 months
|
|
Investigations
Weight gain
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • 13 months
|
50.0%
2/4 • Number of events 2 • 13 months
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 1 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • 13 months
|
0.00%
0/4 • 13 months
|
|
Vascular disorders
Vasculitis
|
0.00%
0/3 • 13 months
|
25.0%
1/4 • Number of events 1 • 13 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place