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

INCLUSION CRITERIA:

- Non-small cell lung adenocarcinoma or squamous cell carcimona

- At least one site of measurable disease by RECIST 1.1

- Arm 5: Received at least one prior line of therapy for incurable or metastatic NSCLC.
Up to one prior line of checkpoint inhibitor therapy is permitted (must have received
at least 4 months of treatment) --OR--

- Arm 6: Received front line immunotherapy (with or without chemotherapy) for incurable
or metastatic NSCLC and did not progress clinically or radiographically per RECIST 1.1
at first imaging assessment, and will begin maintenance immunotherapy with standard of
care pembrolizumab ± pemetrexed.

- Life expectancy ≥18 weeks

- Arm 5: Disease progression at study entry --OR--

- Arm 6: Documented Stable Disease, Partial Response, Complete Response (SD/PR/CR) per
RECIST 1.1 after a minimum of 9 to 12 weeks of front line immunotherapy (with or
without chemotherapy).

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

- 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

- Willing to provide archival or fresh tumor biopsy at Screening, and fresh tumor biopsy
at Week 10 when feasible.

- Arm 5: Suitable for treatment with nivolumab per package insert --OR--

- Arm 6: Suitable for front line maintenance treatment with pembrolizumab ± pemetrexed
per the current approved package inserts.

EXCLUSION CRITERIA:

- Arm 5: Received systemic anticancer therapy within 21 days prior to first dose of
study drug

- Human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled
infections or concurrent illness, unrelated to the tumor, requiring active therapy

- Any condition requiring concurrent systemic immunosuppressive therapy

- Known immunodeficiency disorders, either primary or acquired

- Known leptomeningeal disease

- Active malignancies within 12 months with the exception of those with a negligible
risk of metastasis or death treated with expected curative outcome

- Pregnant or breastfeeding

- Prior participation in a clinical study of viagenpumatucel-L (HS-110)

- Administration of a live vaccine within 30 days prior to first dose of study drug

- Active, known or suspected autoimmune disease

- Significant cardiovascular disease

- Refractory to prior immunotherapy (clinical or radiographic progression after 12 weeks
or less of immunotherapy).