IDO Peptid Vaccination for Stage III-IV Non Small-cell Lung Cancer Patients. (IDOvaccine)

Inclusion Criteria:

1. Histological or cytological verified non small cell lung cancer 2. Metastatic or locally advanced incurable stage III-IV NSCLC 3. Patients need to be off chemotherapy treatment 4. Evaluable disease according to RECIST V. 1,1 criteria 5. Patients must be HLA-A2 positive 6. Patients > 18 years old 7. Performance status 0-1 8. Life expectancy of > 3 months 9. Acceptable bone marrow function, defined as

a. White blood cell count > 2,5 * 109 /l b. Neutrophil count> 1,5 * 109 /l c. Platelet count > 75 * 109/l 10. Creatinin measured < 2,5 * upper limit value 11. Acceptable liver function, defined as

1. ASAT < 100 U/L

2. Bilirubin < 30 U/L 12. Women with child-bearing potential must have controlled s-hcg before inclusion 13. Patients must provide written informed concent before inclusion 13. Termination of chemotherapy treatment > 28 days before inclusion

   14. Termination of radiotherapy treatment > 28 days before inclusion

   15. Inclusion at least > 4 weeks after complicated gastric surgery

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   Exclusion Criteria:

   1. Other malignancies except from non-melanoma skin cancer in the previous 5 years until study inclusion
   2. Brain metastasis are allowed after radical excision, and if the patient at least 1 month afterwards is not in clinical or radiographic progression
   3. Patients with active gastric ulcer disease; patients taking antacid treatment can be included.
   4. Severe medical condition, severe asthma, severe COLD, severe arteriosclerosis or diabetic disease
   5. Acute or chronic infection (ie. HIV, hepatitis, tuberculosis)
   6. Severe allergic reaction or previous anaphylactic shock
   7. Autoimmune diseases (ie. autoimmune neutropenia/thrombopenia, hæmolytic anaemia, systemic lupus erythematosis, Sjøgrens disease, sclerodermia, Goodpastures syndrome, Addisons disease, active Graves disease)
   8. Pregnant or lactating women
   9. Psychiatric disease, which can influence compliance
   10. Known hypersensitivity towards the adjuvance Montanide, the Aldara creme, or adhesive tape.
   11. Treatment with immunosuppressive therapy (ie. dexamethasone, methotrexate)
   12. Treatment with other experimental therapy
   13. Treatment with other anti-cancer therapy, except from treatment of osteoporosis

   14. No systemic chemotherapy, immunotherapy or radiation therapy (except locally) are allowed until 28 days before inclusion.

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