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Immune Response and Safety of HS110 Vaccine in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer

NCT01504542 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-11-21

No results posted yet for this study

Summary

This study will enroll patients with locally advanced or metastatic non-EGFR mutated Non-Small Cell Lung Cancer (NSCLC) lung cancer after failure of at least one but no more than two prior approved treatment regimens. Patients will be randomized to receive one of two doses of vaccine or placebo to be dosed twice weekly for 18 weeks (36 doses total) and patients will also receive erlotinib 150mg taken orally once daily for the duration of the trial. The study will examine the immune effects, safety and efficacy of two different doses of HS110 vaccine in combination with erlotinib versus erlotinib alone.

Conditions

Interventions

BIOLOGICAL

HS110 vaccine

0.5ml to be administered twice weekly for 18 weeks (36 doses)

BIOLOGICAL

Placebo

0.5ml buffered saline placebo to be administered twice weekly for 18 weeks (36 doses)

BIOLOGICAL

HS110 vaccine

0.5 mls to be dosed twice weekly for 18 weeks (36 doses)

Sponsors & Collaborators

  • Heat Biologics

    lead INDUSTRY

Principal Investigators

  • John Nemunaitis, MD · Mary Crowley Cancer Research Centers

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504542 on ClinicalTrials.gov