Trial Outcomes & Findings for A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer (NCT NCT02117024)
NCT ID: NCT02117024
Last Updated: 2020-02-05
Results Overview
Overall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive. Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2020-02-05
Participant Flow
Participant milestones
| Measure |
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
|
Chemotherapy Alone
Patients will be treated with a physician's choice regimen until progression.
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
* Vinorelbine
* Erlotinib
* Gemcitabine
* Paclitaxel
* Docetaxel
* Pemetrexed
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
21
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
44
|
20
|
Reasons for withdrawal
| Measure |
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
|
Chemotherapy Alone
Patients will be treated with a physician's choice regimen until progression.
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
* Vinorelbine
* Erlotinib
* Gemcitabine
* Paclitaxel
* Docetaxel
* Pemetrexed
|
|---|---|---|
|
Overall Study
Progressive Disease
|
26
|
9
|
|
Overall Study
Significant Clinical Progression
|
7
|
4
|
|
Overall Study
Death
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Randomized in Error
|
1
|
0
|
|
Overall Study
Patient returned to primary oncologist
|
0
|
1
|
|
Overall Study
Patient took treatment break
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
n=45 Participants
Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
|
Chemotherapy Alone
n=21 Participants
Patients will be treated with a physician's choice regimen until progression.
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
* Vinorelbine
* Erlotinib
* Gemcitabine
* Paclitaxel
* Docetaxel
* Pemetrexed
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
65 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
|
1 Participants
n=7 Participants
|
1 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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
62 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsOverall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive. Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events
Outcome measures
| Measure |
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
n=45 Participants
Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
|
Chemotherapy Alone
n=21 Participants
Patients will be treated with a physician's choice regimen until progression.
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
* Vinorelbine
* Erlotinib
* Gemcitabine
* Paclitaxel
* Docetaxel
* Pemetrexed
|
|---|---|---|
|
Overall Survival (OS)
|
176 Days
Interval 114.0 to 231.0
|
372 Days
Interval 204.0 to 875.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Safety was defined as the number of adverse events (AE)/serious adverse events (SAE) in patients receiving viagenpumatucel-L and low-dose Cyclophosphamide (CY).
Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events
Outcome measures
| Measure |
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
n=43 Participants
Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
|
Chemotherapy Alone
n=20 Participants
Patients will be treated with a physician's choice regimen until progression.
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
* Vinorelbine
* Erlotinib
* Gemcitabine
* Paclitaxel
* Docetaxel
* Pemetrexed
|
|---|---|---|
|
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Fatal TEAE
|
7 Participants
|
0 Participants
|
|
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
At least one TEAE Leading to Tx Discontinuation
|
7 Participants
|
2 Participants
|
|
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
At least one TEAE Leading to a Dose Reduction
|
0 Participants
|
2 Participants
|
|
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
At least one TEAE
|
41 Participants
|
20 Participants
|
|
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
At least one severe TEAE
|
25 Participants
|
11 Participants
|
|
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
At least one treatment-related TEAE
|
32 Participants
|
15 Participants
|
|
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
At least one SAE
|
17 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data were not collected for Outcome Measure 3 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.
Evaluate overall immune-related DCR (irDCR) and also DCR by Response Evaluation Criteria in Solid Tumors (RECIST) (complete response, partial response, and stable disease)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data were not collected for Outcome Measure 4 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.
Evaluate 6-month immune-related DCR (6m-irDCR) and also 6mDCR by RECIST (complete response, partial response, and stable disease at 6 months following randomization)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data were not collected for Outcome Measure 5 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.
Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Calculated from randomization date to earliest date of first 'Progressive Disease' response (Immune-Related / RECIST Response Criteria) or date of death, and censored on the date of the last available post-baseline tumor assessment.
Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors)
Outcome measures
| Measure |
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
n=45 Participants
Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
|
Chemotherapy Alone
n=21 Participants
Patients will be treated with a physician's choice regimen until progression.
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
* Vinorelbine
* Erlotinib
* Gemcitabine
* Paclitaxel
* Docetaxel
* Pemetrexed
|
|---|---|---|
|
Progression-Free Survival (PFS)
immune-related PFS (irPFS)
|
76.0 Days
Interval 66.0 to 106.0
|
190.0 Days
Interval 72.0 to 445.0
|
|
Progression-Free Survival (PFS)
Progression Free Survival (PFS)
|
70.0 Days
Interval 65.0 to 96.0
|
190.0 Days
Interval 72.0 to 317.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Time to immune-related progression was calculated from the randomization date up to the date of the first 'Progressive Disease' response (Immune-Related Response Criteria) Time to progression was calculated from the randomization date up to the date of the first 'Progressive Disease' response (RECIST Response Criteria).
Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST
Outcome measures
| Measure |
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
n=45 Participants
Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
|
Chemotherapy Alone
n=21 Participants
Patients will be treated with a physician's choice regimen until progression.
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
* Vinorelbine
* Erlotinib
* Gemcitabine
* Paclitaxel
* Docetaxel
* Pemetrexed
|
|---|---|---|
|
Time to Progression (TTP)
immune-related TTP (irTTP)
|
67.0 Days
Interval 61.0 to 76.0
|
71.0 Days
Interval 64.0 to 155.0
|
|
Time to Progression (TTP)
Time to Progression (TTP)
|
67.5 Days
Interval 64.0 to 76.0
|
73.5 Days
Interval 64.0 to 198.0
|
SECONDARY outcome
Timeframe: 6 monthsEvaluate the proportion of patients who are alive at 6 months following randomization
Outcome measures
| Measure |
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
n=45 Participants
Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
|
Chemotherapy Alone
n=21 Participants
Patients will be treated with a physician's choice regimen until progression.
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
* Vinorelbine
* Erlotinib
* Gemcitabine
* Paclitaxel
* Docetaxel
* Pemetrexed
|
|---|---|---|
|
Survival at 6 Months
|
21 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 monthsEvaluate the proportion of patients who are alive at 12 months following randomization
Outcome measures
| Measure |
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
n=45 Participants
Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
|
Chemotherapy Alone
n=21 Participants
Patients will be treated with a physician's choice regimen until progression.
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
* Vinorelbine
* Erlotinib
* Gemcitabine
* Paclitaxel
* Docetaxel
* Pemetrexed
|
|---|---|---|
|
Survival at 12 Months
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data were not collected for Outcome Measure 10 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.
Characterize the peripheral blood immunologic response via intracellular cytokine staining (ICS) by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT) on cluster of differentiation 8 positive (CD8+) cells following vaccination
Outcome measures
Outcome data not reported
Adverse Events
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
Serious events: 17 serious events
Other events: 19 other events
Deaths: 7 deaths
Chemotherapy Alone
Serious events: 8 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
n=43 participants at risk
Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
|
Chemotherapy Alone
n=20 participants at risk
Patients will be treated with a physician's choice regimen until progression.
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
* Vinorelbine
* Erlotinib
* Gemcitabine
* Paclitaxel
* Docetaxel
* Pemetrexed
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/43 • 1 year and 5 months
|
10.0%
2/20 • Number of events 2 • 1 year and 5 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Cardiac disorders
Cardiac Arrest
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Gastrointestinal disorders
Ileus
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Gastrointestinal disorders
Oesophagitis Ulcerative
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43 • 1 year and 5 months
|
10.0%
2/20 • Number of events 2 • 1 year and 5 months
|
|
General disorders
Disease Progression
|
4.7%
2/43 • Number of events 2 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
General disorders
Pain
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Infections and infestations
Oral Candidiasis
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pleural Effusion
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Psychiatric disorders
Mental Status Changes
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
4.7%
2/43 • Number of events 2 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Vascular disorders
Superior Vena Cava Syndrome
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
Other adverse events
| Measure |
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
n=43 participants at risk
Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
|
Chemotherapy Alone
n=20 participants at risk
Patients will be treated with a physician's choice regimen until progression.
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
* Vinorelbine
* Erlotinib
* Gemcitabine
* Paclitaxel
* Docetaxel
* Pemetrexed
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.6%
5/43 • Number of events 5 • 1 year and 5 months
|
20.0%
4/20 • Number of events 5 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.6%
11/43 • Number of events 15 • 1 year and 5 months
|
35.0%
7/20 • Number of events 8 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.0%
3/43 • Number of events 3 • 1 year and 5 months
|
0.00%
0/20 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.7%
2/43 • Number of events 2 • 1 year and 5 months
|
10.0%
2/20 • Number of events 2 • 1 year and 5 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 2 • 1 year and 5 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
10.0%
2/20 • Number of events 2 • 1 year and 5 months
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.7%
2/43 • Number of events 3 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
5.0%
1/20 • Number of events 2 • 1 year and 5 months
|
|
Skin and subcutaneous tissue disorders
Deep Vein Thrombosis
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
|
Skin and subcutaneous tissue disorders
Hot Flush
|
2.3%
1/43 • Number of events 1 • 1 year and 5 months
|
10.0%
2/20 • Number of events 2 • 1 year and 5 months
|
|
Skin and subcutaneous tissue disorders
Superior Vena Cava Syndrome
|
0.00%
0/43 • 1 year and 5 months
|
5.0%
1/20 • Number of events 1 • 1 year and 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place