Trial Outcomes & Findings for Cisplatin and Nab-paclitaxel for (N2) Defined NSCLC (NCT NCT02276560)
NCT ID: NCT02276560
Last Updated: 2017-05-11
Results Overview
N2 disease is defined as involvement of the ipsilateral mediastinal and/or subcarinal lymph nodes; if disease is cleared form these locations, then there is N2 nodal clearance
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
3 Months
Results posted on
2017-05-11
Participant Flow
Participant milestones
| Measure |
Neoadjuvant Cisplatin,Nab-paclitaxel
Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care
Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery
|
Adjuvant Cisplatin,Nab-paclitaxel
Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2
Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2
|
Cisplatin+Pemetrexed or Gemcitabine
Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4
Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Neoadjuvant Cisplatin,Nab-paclitaxel
Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care
Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery
|
Adjuvant Cisplatin,Nab-paclitaxel
Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2
Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2
|
Cisplatin+Pemetrexed or Gemcitabine
Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4
Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Cisplatin and Nab-paclitaxel for (N2) Defined NSCLC
Baseline characteristics by cohort
| Measure |
Neoadjuvant Cisplatin,Nab-paclitaxel
n=1 Participants
Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care
Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery
|
Adjuvant Cisplatin,Nab-paclitaxel
Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2
Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2
|
Cisplatin+Pemetrexed or Gemcitabine
Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4
Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
—
|
—
|
67 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
—
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: The only patient registered before funding was withdrawn could not complete treatment due to adverse events.
N2 disease is defined as involvement of the ipsilateral mediastinal and/or subcarinal lymph nodes; if disease is cleared form these locations, then there is N2 nodal clearance
Outcome measures
Outcome data not reported
Adverse Events
Neoadjuvant Cisplatin,Nab-paclitaxel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Adjuvant Cisplatin,Nab-paclitaxel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cisplatin+Pemetrexed or Gemcitabine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neoadjuvant Cisplatin,Nab-paclitaxel
n=1 participants at risk
Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care
Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery
|
Adjuvant Cisplatin,Nab-paclitaxel
Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2
Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2
|
Cisplatin+Pemetrexed or Gemcitabine
Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4
Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Number of events 1 • Three months
|
—
0/0 • Three months
|
—
0/0 • Three months
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 1 • Three months
|
—
0/0 • Three months
|
—
0/0 • Three months
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1 • Three months
|
—
0/0 • Three months
|
—
0/0 • Three months
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Three months
|
—
0/0 • Three months
|
—
0/0 • Three months
|
|
Metabolism and nutrition disorders
Taste Disturbance
|
100.0%
1/1 • Number of events 1 • Three months
|
—
0/0 • Three months
|
—
0/0 • Three months
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 1 • Three months
|
—
0/0 • Three months
|
—
0/0 • Three months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
1/1 • Number of events 1 • Three months
|
—
0/0 • Three months
|
—
0/0 • Three months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 1 • Three months
|
—
0/0 • Three months
|
—
0/0 • Three months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Number of events 1 • Three months
|
—
0/0 • Three months
|
—
0/0 • Three months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
1/1 • Number of events 1 • Three months
|
—
0/0 • Three months
|
—
0/0 • Three months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
100.0%
1/1 • Number of events 1 • Three months
|
—
0/0 • Three months
|
—
0/0 • Three months
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place