Trial · NCT02117024
A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
NCT02117024, Phase 2, Terminated, Heat Biologics; results first posted 2020-02-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer. Trials, record NCT02117024. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02117024
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
- NCT number
- NCT02117024
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Heat Biologics
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Viagenpumatucel-L, Metronomic Cyclophosphamide, Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)
- First posted
- 2014-04-17
- Last updated
- 2020-02-05
- Results first posted
- 2020-02-05
- Limitations and caveats
Study was discontinued prematurely (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 IO combinations. See NCT02439450.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to 3 years | 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 |
| Secondary | Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Up to 3 years | Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events |
| Secondary | Disease Control Rate (DCR) | Up to 3 years | Evaluate overall immune-related DCR (irDCR) and also DCR by Response Evaluation Criteria in Solid Tumors (RECIST) (complete response, partial response, and stable disease) |
| Secondary | 6-Month Disease Control Rate (6mDCR) | 6 months | 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) |
| Secondary | Overall Response Rate (ORR) | Up to 3 years | Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response) |
| Secondary | Progression-Free Survival (PFS) | Up to 3 years | Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors) |
| Secondary | Time to Progression (TTP) | Up to 3 years | Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST |
| Secondary | Survival at 6 Months | 6 months | Evaluate the proportion of patients who are alive at 6 months following randomization |
| Secondary | Survival at 12 Months | 12 months | Evaluate the proportion of patients who are alive at 12 months following randomization |
| Secondary | Immune Response | Up to 3 years | 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 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Up to 3 years | Days | MEDIAN | |
| SECONDARY | Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Up to 3 years | Safety was defined as the number of adverse events (AE)/serious adverse events (SAE) in patients receiving viagenpumatucel-L and low-dose Cyclophosphamide (CY). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) | Up to 3 years | 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. | ||
| SECONDARY | 6-Month Disease Control Rate (6mDCR) | 6 months | 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. | ||
| SECONDARY | Overall Response Rate (ORR) | Up to 3 years | 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. | ||
| SECONDARY | Progression-Free Survival (PFS) | Up to 3 years | 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. | Days | MEDIAN |
| SECONDARY | Time to Progression (TTP) | Up to 3 years | 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). | Days | MEDIAN |
| SECONDARY | Survival at 6 Months | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Survival at 12 Months | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Immune Response | Up to 3 years | 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. |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 176 | 95% Confidence Interval 114.0 to 231.0 | Days | |
| Overall Survival (OS) | Chemotherapy Alone | 372 | 95% Confidence Interval 204.0 to 875.0 | Days | |
| Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | At least one TEAE | 41 | Participants | |
| Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Chemotherapy Alone | At least one TEAE | 20 | Participants | |
| Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | At least one severe TEAE | 25 | Participants | |
| Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Chemotherapy Alone | At least one severe TEAE | 11 | Participants | |
| Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | At least one treatment-related TEAE | 32 | Participants | |
| Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Chemotherapy Alone | At least one treatment-related TEAE | 15 | Participants | |
| Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | At least one SAE | 17 | Participants | |
| Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Chemotherapy Alone | At least one SAE | 8 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 45 | |
| Overall Study | STARTED | Chemotherapy Alone | 21 | |
| Overall Study | COMPLETED | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 1 | |
| Overall Study | COMPLETED | Chemotherapy Alone | 1 | |
| Overall Study | NOT COMPLETED | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 44 | |
| Overall Study | NOT COMPLETED | Chemotherapy Alone | 20 |
Source ClinicalTrials.gov
Adverse events94
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cough | Respiratory, thoracic and mediastinal disorders | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 5 | 43 | 5 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Chemotherapy Alone | 4 | 20 | 5 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 11 | 43 | 15 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Chemotherapy Alone | 7 | 20 | 8 |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 3 | 43 | 3 |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Chemotherapy Alone | 0 | 20 | 0 |
| other | Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 0 | 43 | 0 |
| other | Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | Chemotherapy Alone | 1 | 20 | 1 |
| other | Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 0 | 43 | 0 |
| other | Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Chemotherapy Alone | 1 | 20 | 1 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 7 | 43 |
| Total, all-cause mortality | Chemotherapy Alone | 0 | 20 |
| Total, other adverse events | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 19 | 43 |
| Total, other adverse events | Chemotherapy Alone | 9 | 20 |
| Total, serious adverse events | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | 17 | 43 |
| Total, serious adverse events | Chemotherapy Alone | 8 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Viagenpumatucel-L Plus Metronomic Cyclophosphamide vs Chemotherapy Alone: Survival at 12 Months | Trial comparisons |
| Viagenpumatucel-L Plus Metronomic Cyclophosphamide vs Chemotherapy Alone: Survival at 6 Months | Trial comparisons |
| Viagenpumatucel-L Plus Metronomic Cyclophosphamide vs Chemotherapy Alone: deaths from any cause | Trial comparisons |
| Viagenpumatucel-L Plus Metronomic Cyclophosphamide vs Chemotherapy Alone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02117024
GET https://conductscience.org/api/trials/v1/NCT02117024/results?page=2