Inoperable Stage III Non-small Cell Lung Cancer Clinical Trial
— LucaVaxOfficial 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
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.
| Status | Not yet recruiting |
| Enrollment | 600 |
| Est. completion date | May 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 intent; 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Kael-GemVax Co., Ltd. | Quintiles, Inc. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
| Secondary | Safety and tolerability of GV1001 | 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). | 2 years | Yes |
| Secondary | Immunological response | To evaluate the immunological response parameters as measured by T- cell functional assays and T-cell sub-population analyses. | 2 years | No |