A Double-blind, Multicenter, Randomized Phase III Study of the Telomerase Vaccine, GV1001 Administered After Curative Intent Chemo-radiotherapy in Patients With Inoperable Stage III Non-small Cell Lung Cancer Compared to Best Supportive Care
Lung cancer (both small cell and non-small cell) is the second most common cancer in both
men (after prostate cancer) and women (after breast cancer). It accounts for about 15% of
all new cancers. Lung cancer is the world's leading cause of cancer death with more than 1.6
million new cases diagnosed each year.
About 85 percent of lung cancer patients have Non-small Cell Lung Cancer (NSCLC ) and are
usually diagnosed with advanced disease and have few treatment options and a very low
survival rate.
Radiotherapy is the treatment of choice in the successful treatment of stage III NSCLC.
However, the 5-year survival for stage III patients treated with radiotherapy alone is less
than 10%. Several types of chemotherapy treatments have been investigated, however, progress
has been limited. Most patients die from relapsed disease.
The peptide telomerase vaccine, GV1001, is under development for use as active immunotherapy
in the treatment of cancer. Normally, the immune system is tolerant to self-proteins and
peptides, while being able to react to foreign pathogens. However, cancer cells are
degenerated cells and many of their peptides and proteins are self-proteins or peptides. By
using vaccination, the immune tolerance towards a specific peptide or protein can be
circumvented.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall survival (OS)
To evaluate OS in inoperable stage III NSCLC patients following chemoradiotherapy administered with a curative intent followed by GV1001 vaccination plus best supportive care (BSC)
2 years
No
Sinae Jeong
Study Director
Kael-GemVax Co., Ltd.
United States: Food and Drug Administration
KG 1/2012
NCT01579188
May 2012
May 2016
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