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

Heat Biologics

Status and phase: Terminated; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Metronomic Cyclophosphamide; Drug: Viagenpumatucel-L; Drug: Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117024

HS110-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• 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

Exclusion criteria

• 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
• Other active malignancies
• Prior treatment with a cancer vaccine for this indication
• Pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Viagenpumatucel-L Plus Metronomic Cyclophosphamide

Experimental group

Description:

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.

Treatment:

Drug: Viagenpumatucel-L

Drug: Metronomic Cyclophosphamide

Chemotherapy Alone

Active Comparator group

Description:

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

Treatment:

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