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