NCT02117024

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

A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failure of Two or Three Previous Treatment Regimens for Advanced Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Heat Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will test whether vaccination with viagenpumatucel-L combined with low-dose cyclophosphamide will prolong the survival of patients with non-small cell lung cancer (NSCLC) who have failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone. Patients will be randomized 2 to 1 into the viagenpumatucel-L arm and the chemotherapy alone arm, respectively.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Viagenpumatucel-L	Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
DRUG	Metronomic Cyclophosphamide	One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
DRUG	Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)	Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: * Vinorelbine * Erlotinib * Gemcitabine * Paclitaxel * Docetaxel * Pemetrexed

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-12-01
• Completion: 2018-04-01
• First posted: 2014-04-17
• Last updated: 2020-02-05
• Results posted: 2020-02-05

Locations

16 sites across 1 country: United States