Inoperable Stage III Non-small Cell Lung CancerPhase 3LucaVaxNCT01579188
Study of the Telomerase Vaccine GV1001 to Treat Patients With Inoperable Stage III Non-small Cell Lung Cancer
A Phase 3 study testing GV1001 and normal saline in people with Inoperable Stage III Non-small Cell Lung Cancer, run by Kael-GemVax Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inoperable Stage III Non-small Cell Lung Cancer
- What is being tested?
- GV1001 and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- May 2012to May 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be entered in the study only if they meet all of the following criteria:
- Male or female patient ≥ 18 years of age;
- Histologically or cytologically confirmed inoperable NSCLC stage III disease;
- 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;
- Life expectancy of ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2;
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- 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);
- 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;
- 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;
- Females of childbearing potential must have a negative pregnancy test;
- Females may not be breastfeeding; and
- Ability to understand and willingness to sign a written informed consent.
Who cannot join
- Patients will not be entered in the study for any of the following reasons:
- 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;
- 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;
- 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;
- 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;
- Are currently receiving any other cancer treatment, even if given with palliative intent;
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- Uncontrolled pleural effusions, ascites, or other third space fluid collections;
- Uncontrolled diabetes mellitus Type 1 or 2;
- 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);
- Patients with organ allografts requiring immunosuppression;
- 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;
- Known severe adverse reactions to vaccines;
- Known severe adverse events or allergy to GM-CSF;
- Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive; and
- Have any medical condition that would interfere with the conduct of the study.
About this study
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
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.
Read the detailed description
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.
- Being tested
- GV1001, normal saline
- Keywords
- NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV1001Drug
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
normal salineDrug
two injections of normal saline injected in the same manner as the experimental drug, GV1001
| Study group | Role | What they receive |
|---|---|---|
| GV1001 | Experimental | 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. Receives: Drug: GV1001 |
| Placebo | Placebo comparator | Placebo Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Secondary outcomes (2)
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).
Measured: 2 years
Immunological response
To evaluate the immunological response parameters as measured by T- cell functional assays and T-cell sub-population analyses.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inoperable Stage III Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kael-GemVax Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Sinae Jeong, Study director, Kael-GemVax Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579188
- Sponsor's protocol ID
- KG 1/2012
- Acronym
- LucaVax
- Status last verified
- Apr 2012
- First submitted
- 13 Apr 2012
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01579188
- Acronym / sponsor ID
- LucaVax / KG 1/2012
- Keywords
- NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kael-GemVax Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- May 2012
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 17 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GV1001 | Experimental | Drug: GV1001The adjuvant GM-CSF is administered first as an intradermal injection followed in 10-15 minutes by the GV1001 peptide injected into the same site. |
| Placebo | Placebo comparator | Drug: normal salinePlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patient ≥ 18 years of age;
- Histologically or cytologically confirmed inoperable NSCLC stage III disease;
- 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;
- Life expectancy of ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2;
Key exclusion criteria (15 listed)
- 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;
- 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;
- 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;
- 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;
- Are currently receiving any other cancer treatment, even if given with palliative intent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GV1001Intradermal 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 | Drug | GV1001 |
| normal salinetwo injections of normal saline injected in the same manner as the experimental drug, GV1001 | Drug | Placebo |
Primary outcome
Overall survival (OS)
Time frame: 2 years
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 secondary outcomes
Safety and tolerability of GV1001
Time frame: 2 years
Immunological response
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sinae Jeong study director
Kael-GemVax Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GV1001 and normal saline in people with Inoperable Stage III Non-small Cell Lung Cancer, run by Kael-GemVax Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.