Universal Cancer Peptide-based Vaccination in Metastatic NSCLC

Korábbi kezelés

• Symptomatic brain metastases. Patients with controlled brain metastases after radiation therapy or with asymptomatic brain metastases may be included.
• Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment

Más betegség

• Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
• History of active autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease…)
• Patients with any medical or psychiatric condition or disease,

Laborértékek

• Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed) - - Positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C virus (HCV); presence in the serum of the antigens HBs

Egyéb

• Pregnancy or lactating patients.
• Patients under guardianship, curatorship or under the protection of justice.

• Written informed consent
• Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
• Stage IIIB not amenable to radiotherapy or stage IV cancer according to the TNM classification (7th edition) or recurrent NSCLC after surgery not amenable to loco-regional therapy.
• Pre-treated with at least 2 or 3 lines of treatment (including immunotherapy). Chemoradiation for stage IIIB disease is considered as one treatment line.
• At least one measurable lesion by CT scan or MRI based on RECIST criteria version 1.1
• Performance status 0 or 1 on the ECOG scale
• Life-expectancy > 3 months
• Adequate hematological, hepatic, and renal function