NCT01774578

An Open-label, Randomized Phase IIB/III Active Control Study of Second-line Tergenpumatucel-L (Hyper-Acute(R)-Lung ) Immunotherapy Versus Docetaxel in Progressive or Relapsed Non-Small Cell Lung Cancer

Terminated Phase 2/Phase 3 Last updated 26 May 2020

What this trial tests

Phase 2/Phase 3 trial testing Docetaxel in Non-small Cell Lung Cancer in 135 participants. Terminated before completion.

Timeline

1 February 2013

Primary endpoint
18 May 2016

18 June 2016

Quick facts

Lead sponsor	NewLink Genetics Corporation
Phase	Phase 2/Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	135
Start date	1 February 2013
Primary completion	18 May 2016
Estimated completion	18 June 2016
Sites	24 locations across United States

Drugs / interventions tested

• Docetaxel (Docetaxel) — full drug profile →
• HyperAcute®-Lung Immunotherapy
• Gemcitabine (gemcitabine) — full drug profile →
• Pemetrexed — full drug profile →

Conditions studied

• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
• Progression of Non-small Cell Lung Cancer — all drugs for Progression of Non-small Cell Lung Cancer →
• Non-small Cell Lung Cancer Recurrent — all drugs for Non-small Cell Lung Cancer Recurrent →

Sponsor

NewLink Genetics Corporation — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer or Progression of Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Overall survival
  Time frame: Approximately 19 months, assuming a 24 month enrollment.
  The primary objective in Phase IIB and Phase III is to assess overall survival of anti-tumor immunization using HyperAcute®-Lung (HAL) Immunotherapy versus docetaxel in patients with progressed or relapsed non-small cell lung cancer (NSCLC) that have been previously treated.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Molecular pathways and therapeutic targets in lung cancer.
   Shtivelman E, Hensing T, Simon GR, Dennis PA, et al · · 2014 · cited 150× · PMID 24722523 · DOI 10.18632/oncotarget.1891
2. Current state of immunotherapy for non-small cell lung cancer.
   Malhotra J, Jabbour SK, Aisner J. · · 2017 · cited 147× · PMID 28529902 · DOI 10.21037/tlcr.2017.03.01
3. Whole tumour cell-based vaccines: tuning the instruments to orchestrate an optimal antitumour immune response.
   Pérez-Baños A, Gleisner MA, Flores I, Pereda C, et al · · 2023 · cited 54× · PMID 37355722 · DOI 10.1038/s41416-023-02327-6
4. Cell death pathologies: targeting death pathways and the immune system for cancer therapy.
   Pentimalli F, Grelli S, Di Daniele N, Melino G, et al · · 2019 · cited 48× · PMID 30563970 · DOI 10.1038/s41435-018-0052-x
5. Immunotherapy for non-small cell lung cancer: current concepts and clinical trials.
   Mayor M, Yang N, Sterman D, Sterman D, et al · · 2016 · cited 27× · PMID 26516195 · DOI 10.1093/ejcts/ezv371
6. Immunotherapy prospects in the treatment of lung cancer and mesothelioma.
   Aerts JG, Lievense LA, Hoogsteden HC, Hegmans JP. · · 2014 · cited 19× · PMID 25806279 · DOI 10.3978/j.issn.2218-6751.2013.11.04
7. Therapeutic cancer vaccines and combination immunotherapies involving vaccination.
   Nguyen T, Urban J, Kalinski P. · · 2014 · cited 9× · PMID 27471705 · DOI 10.2147/itt.s40264
8. Current Development of Therapeutic Vaccines in Lung Cancer.
   Flores Banda JS, Gangane S, Raza F, Massarelli E. · · 2025 · cited 4× · PMID 40006732 · DOI 10.3390/vaccines13020185