Trial Outcomes & Findings for Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients (NCT NCT03081689)
NCT ID: NCT03081689
Last Updated: 2024-12-04
Results Overview
The progression free survival is the percentage of the patients without disease progression
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
at 24 months from the first dose of neoadjuvant treatment
Results posted on
2024-12-04
Participant Flow
Participant milestones
| Measure |
Arm 1
Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Nivolumab 360 mg: Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Paclitaxel 200mg/m2: Paclitaxel 200mg/m2 IV Q3W
Carboplatin AUC 6: Carboplatin AUC 6 IV Q3W
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients
Baseline characteristics by cohort
| Measure |
Arm 1
n=46 Participants
Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Nivolumab 360 mg: Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Paclitaxel 200mg/m2: Paclitaxel 200mg/m2 IV Q3W
Carboplatin AUC 6: Carboplatin AUC 6 IV Q3W
|
|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
46 participants
n=5 Participants
|
|
ECOG Performance Status Scale
ECOG 0
|
25 Participants
n=5 Participants
|
|
ECOG Performance Status Scale
ECOG 1
|
21 Participants
n=5 Participants
|
|
ECOG Performance Status Scale
ECOG 2
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status Scale
ECOG 3
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status Scale
ECOG 4
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status Scale
ECOG 5
|
0 Participants
n=5 Participants
|
|
Cigarette Smoking History
Former smoker (≥ 1 year)
|
25 Participants
n=5 Participants
|
|
Cigarette Smoking History
Current smoker
|
21 Participants
n=5 Participants
|
|
Cigarette Smoking History
Never smoker
|
0 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
26 Participants
n=5 Participants
|
|
Histology
Squamous
|
16 Participants
n=5 Participants
|
|
Histology
NOS/Undifferenciated
|
4 Participants
n=5 Participants
|
|
Tumor node, metastasis staging classification
T1N2M0
|
15 Participants
n=5 Participants
|
|
Tumor node, metastasis staging classification
T2N1M0
|
1 Participants
n=5 Participants
|
|
Tumor node, metastasis staging classification
T2N2M0
|
6 Participants
n=5 Participants
|
|
Tumor node, metastasis staging classification
T3N1M0
|
1 Participants
n=5 Participants
|
|
Tumor node, metastasis staging classification
T3N2M0
|
13 Participants
n=5 Participants
|
|
Tumor node, metastasis staging classification
T4N0M0
|
9 Participants
n=5 Participants
|
|
Tumor node, metastasis staging classification
T1N1M0
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 24 months from the first dose of neoadjuvant treatmentThe progression free survival is the percentage of the patients without disease progression
Outcome measures
| Measure |
Arm 1
n=46 Participants
Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Nivolumab 360 mg: Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Paclitaxel 200mg/m2: Paclitaxel 200mg/m2 IV Q3W
Carboplatin AUC 6: Carboplatin AUC 6 IV Q3W
|
|---|---|
|
Progression Free Survival
|
77.1 percentage of participants
Interval 59.9 to 87.7
|
SECONDARY outcome
Timeframe: at 3 years from the first dose of neoadjuvant treatmentPercentage of patients are still alive
Outcome measures
| Measure |
Arm 1
n=46 Participants
Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Nivolumab 360 mg: Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Paclitaxel 200mg/m2: Paclitaxel 200mg/m2 IV Q3W
Carboplatin AUC 6: Carboplatin AUC 6 IV Q3W
|
|---|---|
|
Overall Survival
|
89.9 percentage of participants
Interval 74.5 to 96.2
|
Adverse Events
Arm 1
Serious events: 3 serious events
Other events: 43 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1
n=46 participants at risk
Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Nivolumab 360 mg: Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Paclitaxel 200mg/m2: Paclitaxel 200mg/m2 IV Q3W
Carboplatin AUC 6: Carboplatin AUC 6 IV Q3W
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.2%
1/46 • Number of events 1 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Blood and lymphatic system disorders
Increased lipase
|
4.3%
2/46 • Number of events 2 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
Other adverse events
| Measure |
Arm 1
n=46 participants at risk
Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Nivolumab 360 mg: Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Paclitaxel 200mg/m2: Paclitaxel 200mg/m2 IV Q3W
Carboplatin AUC 6: Carboplatin AUC 6 IV Q3W
|
|---|---|
|
General disorders
Asthenia or fatigue
|
50.0%
23/46 • Number of events 51 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.0%
17/46 • Number of events 17 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Gastrointestinal disorders
Nausea
|
32.6%
15/46 • Number of events 20 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Nervous system disorders
Neurotoxicity
|
28.3%
13/46 • Number of events 15 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.1%
12/46 • Number of events 19 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Gastrointestinal disorders
Diarrhoea
|
23.9%
11/46 • Number of events 18 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Skin and subcutaneous tissue disorders
Skin disorders (rash)
|
41.3%
19/46 • Number of events 40 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.6%
9/46 • Number of events 14 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
8/46 • Number of events 12 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
General disorders
Decreased appetite or anorexia
|
19.6%
9/46 • Number of events 16 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
General disorders
Constipation
|
17.4%
8/46 • Number of events 12 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Nervous system disorders
Paraesthesia
|
17.4%
8/46 • Number of events 12 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.3%
13/46 • Number of events 20 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Blood and lymphatic system disorders
Anaemia
|
15.2%
7/46 • Number of events 7 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Blood and lymphatic system disorders
Increased aminotransferases
|
10.9%
5/46 • Number of events 5 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Blood and lymphatic system disorders
Increased serum amylase
|
6.5%
3/46 • Number of events 6 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Blood and lymphatic system disorders
Increased creatinine level
|
6.5%
3/46 • Number of events 3 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
|
Blood and lymphatic system disorders
Increased lipase
|
8.7%
4/46 • Number of events 7 • 40 months
The severity of AE will be determined using CTCAE version 4.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place