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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

Phase 3
18 Years
Not Enrolling
Inoperable Stage III Non-small Cell Lung Cancer

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Trial Information

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

Inclusion Criteria:

Patients may be entered in the study only if they meet all of the following criteria:

1. Male or female patient ≥ 18 years of age;

2. Histologically or cytologically confirmed inoperable NSCLC stage III disease;

3. Patient must have received chemo-radiotherapy with a curative intent with the
following definition: any planned regimen consisting of a platinum-doublet containing
chemotherapy given concomitantly with up to 66Gy of radiation therapy. Gemcitabine
cannot be part of the platinum-based doublet;

4. Life expectancy of ≥ 3 months;

5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2;

6. Patients must have adequate bone marrow function as evidenced by absolute neutrophil
count (ANC) ≥ 1.0 X 109/L, hemoglobin ≥ 9.0 g/dL (a hemoglobin < 9.0 g/dL at
Screening is acceptable if it is corrected to ≥ 9 g/dL by growth factor or
transfusion prior to first dose), and platelet count ≥ 75 X 109/L (platelet counts
below 75 X 109/L may be re-screened within 4 weeks of chemoradiotherapy);

7. Patients must have adequate liver function as evidenced by bilirubin ≤ 1.5 times the
upper limit of the normal range (ULN), and alkaline phosphatase, alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 X ULN;

8. Female patients of childbearing potential (i.e. ovulating, premenopausal, not
surgically sterile), and all male patients are required to be sexually abstinent or
use a medically accepted contraceptive regimen during their participation in the
study and for 90 days after study completion. Medically accepted contraceptive
methods are defined as those with 90% or greater efficacy;

9. Females of childbearing potential must have a negative pregnancy test;

10. Females may not be breastfeeding; and

11. Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

Patients will not be entered in the study for any of the following reasons:

1. Prior treatment with gemcitabine, prior targeted therapy (including erlotinib
[Tarceva®], or gefitinib [Iressa®]), or immunological therapy including tumor vaccine
therapy intended for the management of NSCLC;

2. A minimum of 1 week and a maximum of 4 weeks must have elapsed from the
chemo-radiotherapy and patient must have recovered from all treatment-related
toxicities to Grade ≤ 1 (CTCAE version 4.03), except for alopecia;

3. History of other malignancies except: (1) adequately treated basal or squamous cell
carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine
cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively
treated solid tumor with no evidence of disease for ≥ 3 years;

4. Received treatment in another clinical study within the 30 days prior to commencing
study treatment or patients who have not recovered from side effects of an
investigational drug to Grade ≤ 1 (CTCAE version 4.03), except for alopecia;

5. Are currently receiving any other cancer treatment, even if given with palliative

6. Uncontrolled pleural effusions, ascites, or other third space fluid collections;

7. Uncontrolled diabetes mellitus Type 1 or 2;

8. Significant cardiovascular impairment (history of congestive heart failure > New York
Heart Association (NYHA) Grade II, unstable angina or myocardial infarction within
the past 6 months, or serious cardiac arrhythmia);

9. Patients with organ allografts requiring immunosuppression;

10. Need for systemic steroid treatment unless chronic daily dose used is ≤ 5mg
prednisone or equivalent. Note: Higher dose systemic steroid treatment (≥ 60mg/day of
prednisone or equivalent) administered for ≤ 2 weeks in any single episode is
permissible if administered for an acute inflammatory condition;

11. Known severe adverse reactions to vaccines;

12. Known severe adverse events or allergy to GM-CSF;

13. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen,
or hepatitis C positive; and

14. Have any medical condition that would interfere with the conduct of the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival (OS)

Outcome Description:

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)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Sinae Jeong

Investigator Role:

Study Director

Investigator Affiliation:

Kael-GemVax Co., Ltd.


United States: Food and Drug Administration

Study ID:

KG 1/2012



Start Date:

May 2012

Completion Date:

May 2016

Related Keywords:

  • Inoperable Stage III Non-small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms