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

• Status: Terminated
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heat Biologics
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Docetaxel; Erlotinib Hydrochloride; Gemcitabine; Paclitaxel; Pemetrexed; Vinorelbine

Criteria

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