Neoplasms

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Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Adenocarcinoma of Lung

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Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Micronutrients

Hematinics

Vitamins

Amino Acids

Gemcitabine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Vaccines

Vinorelbine

Cyclophosphamide

Pemetrexed

Immunomodulating Agents

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Tyrosine

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.

Patients will be treated with a physician's choice regimen until progression.

Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig

Viagenpumatucel-L

One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks

Metronomic Cyclophosphamide

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

Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)

Roger Cohen, MD

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.

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.

A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer

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

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

Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events

Evaluate overall immune-related DCR (irDCR) and also DCR by Response Evaluation Criteria in Solid Tumors (RECIST) (complete response, partial response, and stable disease)

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)

Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response)

Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors)

Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST

Evaluate the proportion of patients who are alive at 6 months following randomization

Evaluate the proportion of patients who are alive at 12 months following randomization

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

Heat Biologics

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

Viagenpumatucel-L Plus Metronomic Cyclophosphamide

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

Chemotherapy Alone

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Australia

Region of Enrollment

Sixty-six of the original 123 planned patients were enrolled from June 2014 to 10 September 2015. Patients were randomized in a 2:1 ratio in the experimental group (n=45) and the control group (n=21). Sixty-three patients were included in the safety population.

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.

Lori McDermott

With only 50% of enrollment complete prior to study termination by sponsor, insufficient sample size exists to fully complete efficacy analysis.

Overall Survival (OS)

At least one TEAE

At least one severe TEAE

At least one treatment-related TEAE

At least one SAE

Fatal TEAE

At least one TEAE Leading to Tx Discontinuation

At least one TEAE Leading to a Dose Reduction

Safety was defined as the number of adverse events (AE)/serious adverse events (SAE) in patients receiving viagenpumatucel-L and low-dose Cyclophosphamide (CY).

Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)

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.

Disease Control Rate (DCR)

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.

6-Month Disease Control Rate (6mDCR)

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.

Overall Response Rate (ORR)

immune-related PFS (irPFS)

Progression Free Survival (PFS)

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.

Progression-Free Survival (PFS)

immune-related TTP (irTTP)

Time to Progression (TTP)

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).

Survival at 6 Months

Survival at 12 Months

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.

Spots Global Cancer Trial Database for physician's choice regimen (vinorelbine, erlotinib, gemcitabine, paclitaxel, docetaxel, pemetrexed)