Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
NSCLC, vaccination, Inoperable NSCLC stage IIIA/B in good performance status
Brief summary
To examine the safety and efficacy of telomerase peptide vaccination ( stimulation of the immune system) in patients with NSCLC after having been treated with conventional therapy with radiotherapy and docetaxel as a radiosensitizer.
Detailed description
Survival in patients with locally advanced, inoperable NSCLC may be improved if local control can be achieved with concurrent chemo radiotherapy .After completed standard chemo-and radiation therapy; the safety and efficacy of vaccination therapy will be measured as time to progression after treatment with GV1001. Analysis of changes in T-cell subpopulations and cytokines in peripheral blood will be performed.
Interventions
BIOLOGICALGV 1001 Telomerase peptide
Sponsors
St. Olavs Hospital
Sorlandet Hospital HF
Oslo University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with inoperable NSCLC, disease stage IIIA and stage IIIB, who has received concurrent chemoradiotherapy( typically docetaxel 20 mg/m2 and 3D radiotherapy, 2Gy x 30 within the last 4 weeks. * No sign of brain metastasis( excluded by MRI of the brain) * Male or female above the age of 18 years. * Normal lab. values
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine if combined chemoradiotherapy in patients with NSCLC followed by vaccination( immunotherapy) will increase the immunological response compared to previous experience | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of T cell responders and DTH responders, time to progression of disease | — |
Countries
Norway
Outcome results
None listed