Trials Sponsors Conditions Drugs Pricing

Conditions

Inoperable Stage III Non-small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Safety and tolerability of GV1001
2 years
Immunological response
2 years

Study Arms (2)

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.

Drug: GV1001

Placebo

PLACEBO COMPARATOR

Placebo

Drug: normal saline

Interventions

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

GV1001

normal salineDrug

two injections of normal saline injected in the same manner as the experimental drug, GV1001

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients may be entered in the study only if they meet all of the following criteria:
Male or female patient ≥ 18 years of age;

Sponsors & Collaborators

Kael-GemVax Co., Ltd.
Industrylead
Quintiles, Inc.
Industrycollaborator

MeSH Terms

Interventions

GV1001 peptideSaline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

Sinae Jeong
Kael-GemVax Co., Ltd.
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 17, 2012

Study Start

May 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2016

You may not qualify if:

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;
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.

Study of the Telomerase Vaccine GV1001 to Treat Patients With Inoperable Stage III Non-small Cell Lung Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

GV1001

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

GV1001

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record