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, but no more than three prior lines of therapy, for incurable (i.e. unresectable) or metastatic NSCLC. Up to one prior line of FDA-approved 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 the most recent 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).