Non Small Cell Lung CancerPhase 2NCT02117024
A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
A Phase 2 study testing Viagenpumatucel-L, Metronomic Cyclophosphamide and Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed) in people with Non Small Cell Lung Cancer, run by Heat Biologics at 16 sites in United States.
Trial summary
Determine whether viagenpumatucel-L combined with low-dose cyclophosphamide prolongs survival in patients with NSCLC who failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Viagenpumatucel-L, Metronomic Cyclophosphamide and Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 16 sitesUnited States
- Study dates
- Jul 2014to Apr 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-small cell lung adenocarcinoma
- At least 2 and no more than 3 prior lines of therapy for incurable or metastatic NSCLC
- Suitable for conventional single agent chemotherapy
- Disease progression at study entry
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1; PS=2 patients may be considered
- Central nervous system (CNS) metastases may be permitted but must be treated and neurologically stable
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- Adequate laboratory parameters
- Willing and able to comply with the protocol and sign informed consent
- Female patients who are of childbearing potential and fertile male patients must agree to use an effective form of contraception throughout study participation
Who cannot join
- Received systemic anticancer therapy or radiation therapy within the previous 14 days
- Received more than 3 lines of prior conventional therapy for advanced disease
- Human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled infections or intercurrent illness, unrelated to the tumor, requiring active therapy
- Any condition requiring concurrent systemic immunosuppressive therapy
- Known immunodeficiency disorders
- Known leptomeningeal disease
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- Other active malignancies
- Prior treatment with a cancer vaccine for this indication
- Pregnant or breastfeeding
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Texas Oncology PA Texas Cancer Center
Abilene, Texas, 79606
Georgia Regents University
Augusta, Georgia, 30912
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Gabrail Cancer Center
Canton, Ohio, 44718
Mary Crowley Cancer Center
Dallas, Texas, 75201
Aurora Research Institute
Green Bay, Wisconsin, 54311
University of California San Diego
La Jolla, California, 92093
University of California at Los Angeles
Los Angeles, California, 90029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Providence Portland Medical Center- Providence Lung Cancer Clinic
Portland, Oregon, 97213
Highlands Oncology Group
Rogers, Arkansas, 72758
University of California Davis
Sacramento, California, 95817
Cancer Care Northwest
Spokane, Washington, 99216
Washington University School of Medicine
St Louis, Missouri, 63110
SUNY Syracuse
Syracuse, New York, 13210
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failure of Two or Three Previous Treatment Regimens for Advanced Disease
Determine whether viagenpumatucel-L combined with low-dose cyclophosphamide prolongs survival in patients with NSCLC who failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone.
Read the detailed description
This study will test whether vaccination with viagenpumatucel-L combined with low-dose cyclophosphamide will prolong the survival of patients with non-small cell lung cancer (NSCLC) who have failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone. Patients will be randomized 2 to 1 into the viagenpumatucel-L arm and the chemotherapy alone arm, respectively.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Viagenpumatucel-L, Metronomic Cyclophosphamide, Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)
- Keywords
- lung, cancer, gp96, vaccine, immunotherapy, Heat Biologics, cyclophosphamide, vinorelbine, erlotinib, gemcitabine, paclitaxel, docetaxel, pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viagenpumatucel-LDrug
Also called HS-110
Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Metronomic CyclophosphamideDrug
One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Viagenpumatucel-L Plus Metronomic Cyclophosphamide | Experimental | 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. Receives: Drug: Viagenpumatucel-L; Drug: Metronomic Cyclophosphamide |
| Chemotherapy Alone | Active comparator | Patients will be treated with a physician's choice regimen until progression. Receives: Drug: Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
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
Measured: Up to 3 years
Secondary outcomes (9)
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events
Measured: Up to 3 years
Disease Control Rate (DCR)
Evaluate overall immune-related DCR (irDCR) and also DCR by Response Evaluation Criteria in Solid Tumors (RECIST) (complete response, partial response, and stable disease)
Measured: Up to 3 years
6-Month Disease Control Rate (6mDCR)
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)
Measured: 6 months
Overall Response Rate (ORR)
Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response)
Measured: Up to 3 years
Progression-Free Survival (PFS)
Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors)
Measured: Up to 3 years
Time to Progression (TTP)
Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST
Measured: Up to 3 years
Survival at 6 Months
Evaluate the proportion of patients who are alive at 6 months following randomization
Measured: 6 months
Survival at 12 Months
Evaluate the proportion of patients who are alive at 12 months following randomization
Measured: 12 months
Immune Response
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
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2017
- Study completionApr 2018
Why it stopped: Sponsor Decision; strategic - based on changing treatment landscape
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heat Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Cohen, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117024
- Sponsor's protocol ID
- HS110-201
- Status last verified
- Jan 2020
- First submitted
- 15 Apr 2014
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failure of Two or Three Previous Treatment Regimens for Advanced Disease
- ClinicalTrials.gov ID
- NCT02117024
- Acronym / sponsor ID
- HS110-201
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- lung, cancer, gp96, vaccine, immunotherapy, Heat Biologics, cyclophosphamide, vinorelbine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision; strategic - based on changing treatment landscape
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Heat BiologicsIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine whether viagenpumatucel-L combined with low-dose cyclophosphamide prolongs survival in patients with NSCLC who failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone.
Detailed description
This study will test whether vaccination with viagenpumatucel-L combined with low-dose cyclophosphamide will prolong the survival of patients with non-small cell lung cancer (NSCLC) who have failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone. Patients will be randomized 2 to 1 into the viagenpumatucel-L arm and the chemotherapy alone arm, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viagenpumatucel-L Plus Metronomic Cyclophosphamide | Experimental | Drug: Viagenpumatucel-L, Drug: Metronomic CyclophosphamideViagenpumatucel-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. |
| Chemotherapy Alone | Active comparator | Drug: Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)Patients will be treated with a physician's choice regimen until progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Non-small cell lung adenocarcinoma
- At least 2 and no more than 3 prior lines of therapy for incurable or metastatic NSCLC
- Suitable for conventional single agent chemotherapy
- Disease progression at study entry
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1; PS=2 patients may be considered
Key exclusion criteria (9 listed)
- Received systemic anticancer therapy or radiation therapy within the previous 14 days
- Received more than 3 lines of prior conventional therapy for advanced disease
- Human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled infections or intercurrent illness, unrelated to the tumor, requiring active therapy
- Any condition requiring concurrent systemic immunosuppressive therapy
- Known immunodeficiency disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viagenpumatucel-LAlso: HS-110Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig | Drug | Viagenpumatucel-L Plus Metronomic Cyclophosphamide |
| Metronomic CyclophosphamideOne 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks | Drug | Viagenpumatucel-L Plus Metronomic Cyclophosphamide |
| 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 | Drug | Chemotherapy Alone |
Primary outcome
Overall Survival (OS)
Time frame: 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
9 secondary outcomes
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Time frame: Up to 3 years
Disease Control Rate (DCR)
Time frame: Up to 3 years
6-Month Disease Control Rate (6mDCR)
Time frame: 6 months
Overall Response Rate (ORR)
Time frame: Up to 3 years
Progression-Free Survival (PFS)
Time frame: Up to 3 years
Time to Progression (TTP)
Time frame: Up to 3 years
Survival at 6 Months
Time frame: 6 months
Survival at 12 Months
Time frame: 12 months
Immune Response
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Cohen, MD principal investigator
University of Pennsylvania
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Viagenpumatucel-L, Metronomic Cyclophosphamide and Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed) in people with Non Small Cell Lung Cancer, run by Heat Biologics at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.