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

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