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Immunotherapy Study in Progressive or Relapsed Non-Small Cell Lung Cancer

NCT01774578 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2020-05-28

No results posted yet for this study

Summary

The purpose of this study is to assess overall survival of anti-tumor immunization using HyperAcute®-Lung immunotherapy versus Docetaxel in patients with progressed or relapsed non-small cell lung cancer (NSCLC) that have been previously treated.

Conditions

Interventions

DRUG

Docetaxel

Docetaxel given in Arm 1 prior to first progression on study. Given as an option of salvage therapy after first progression on study for Arms 2a and 2b.

BIOLOGICAL

HyperAcute®-Lung Immunotherapy

HAL-1, HAL-2 and HAL-3 immunotherapy components. Up to 16 immunizations of 300 million immunotherapy cells.

DRUG

Gemcitabine

Given as an option of salvage therapy after first progression on study for Arms 1, 2a and 2b.

DRUG

Pemetrexed

Given as an option of salvage therapy after first progression on study for Arms 1, 2a and 2b.

Sponsors & Collaborators

  • NewLink Genetics Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2016-05-18
Completion
2016-06-18

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 NCT01774578 on ClinicalTrials.gov