Study of the Telomerase Vaccine GV1001 to Treat Patients With Inoperable Stage III Non-small Cell Lung Cancer (LucaVax)
The purpose of this study is to evaluate survival in inoperable stage III Non-small Cell Lung Cancer patients following chemo-radiotherapy followed by GV1001 vaccination plus best supportive care.
Inoperable Stage III Non-small Cell Lung Cancer
Drug: normal saline
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]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)
- Safety and tolerability of GV1001 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To evaluate the safety and tolerability of GV1001, progression-free survival (PFS), and QoL using the general EuroQoL Five Dimensional Questionnaire (EQ-5D) and the Lung Cancer Symptom Scale (LCSS).
- Immunological response [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the immunological response parameters as measured by T- cell functional assays and T-cell sub-population analyses.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
The adjuvant GM-CSF is administered first as an intradermal injection followed in 10-15 minutes by the GV1001 peptide injected into the same site.
Intradermal injection 0.84 mg ± 0.084 mg 3 times in Week 1 (Monday, Wednesday, and Friday) and once (Mondays) in Weeks 2, 3, 4, 6, 8, and 10, followed by boost injections given on Weeks 14, 18, 22, 26, and thereafter at 12 week intervals up to Week 98
Placebo Comparator: Placebo
Drug: normal saline
two injections of normal saline injected in the same manner as the experimental drug, GV1001
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.