NCT01774578

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: NewLink Genetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Non-small cell lung cancer (NSCLC) remains the leading cause of cancer death in men and women in the United States. Despite advances in the treatment of advanced NSCLC in the last decade, survival outcomes remain poor. Treatment benefit from cytotoxic chemotherapy has reached a plateau and further progress will depend upon identifying novel methods to target tumor cells. Harnessing the human immune system to target lung cancer could result in the development of effective treatment options against lung cancer and potentially enhance the effect of cytotoxic chemotherapy. Lung cancer cells produce a number of abnormal proteins or abnormal amounts of certain proteins found in normal lung cells. In some cancers, the abnormal protein expression may lead to an immune response against the cancer cells much in the way the immune system responds to an infection. In progressive lung cancer however, the immune system fails to identify or respond to these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet fully understood. This clinical trial proposes a novel method to stimulate the immune system to recognize the abnormal components found in lung cancer cells and to stimulate an immune response that destroys or blocks the growth of the cancer. This new method of treatment helps the immune system of lung cancer patients to "identify" and target the cancerous tissue. As an example, patients who receive an organ transplant to replace a damaged kidney or heart are treated with special drugs to supress their immune response from destroying or "rejecting" the transplanted organ. This "rejection" occurs when the patient's immune system responds to differences between the cells of the transplanted organ and their own immune system by attacking the foreign tissue in the same way as it would attack infected tissue. When the differences between foreign tissues and the patient's body are even larger, perhaps like differences between organs from pigs and the immune system cells of humans, the rejection is very rapid, highly destructive and the immunity it generates is long-lasting. This is called hyperacute rejection and the medicine used to immunize patients in this protocol tries to harness this response to teach a patient's immune system to fight their lung cancer just as the body would learn to reject a transplanted organ from an animal. To do this, we have placed a mouse gene into cultured human lung cancer cell lines. These cells will express a sugar that will stimulate a strong immune response in humans. These cancer cells are irradiated to prevent any growth and then injected along with chemotherapy to patients with lung cancer. The presence of the sugar will stimulate the patient's immune system to kill the injected immunotherapy cells. As part of the process of destroying the immunotherapy cells, the patient's immune system is stimulated to identify as many differences between these cancer cells and normal human cells. This extra stimulation is thought to encourage immune responses against the lung cancer in the patient based on shared abnormalities of lung cancer immunotherapy cells and the patient's lung cancer cells. In this experimental therapy, patients are given docetaxel or injections of an immunotherapy consisting of three types of modified lung cancer cells. We propose to test these treatments in patients with lung cancer who have progressed after initial chemotherapy to demonstrate that treatment of immunotherapy results in improved tumor stabilization or response and could potentially improve the patient's overall survival.

Conditions

• Non-small Cell Lung Cancer
• Progression of Non-small Cell Lung Cancer
• Non-small Cell Lung Cancer Recurrent

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-05-18
• Completion: 2016-06-18
• First posted: 2013-01-24
• Last updated: 2020-05-28

Locations

24 sites across 1 country: United States