Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer

Inclusion Criteria

• •Histologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
• •Stage IV cancer according to TNM classification (7th edition - UICC, December 2009; includes tumor with malignant pleural or pericardial effusion
• •Tumor biopsy specimen with ≥ 50% of MUC1 expressing tumor cells determined by Immunohistochemistry (IHC) staining on fixed pathological material. Biopsy may come either from the primary tumor or from a metastasis. Cytological material is not accepted for this analysis
• •Patient's naïve to first-line therapy for the advanced stage of the disease. Previous neoadjuvant or adjuvant therapy is allowed for patients who successfully underwent complete radical surgery and if last treatment was administered more than 12 months prior to the start of the study treatment, i.e., D1 of Cycle 1.
• •At least one measurable lesion by CT scan or MRI based on RECIST version 1.1
• •PS 0 or 1 on the ECOG scale
• •Adequate hematological, hepatic, and renal function:
• •* Hemoglobin ≥ 10.0 g/dL
• •* White Blood Cells (WBC) ≥ 3.0x10E9/L including
• •* Neutrophils ≥ 1.5x109/L
• •* Total lymphocytes count ≥ 0.5x10E9/L
• •* Platelets count ≥ 100x10E9/L
• •* Serum alkaline phosphatase ≤ 3x ULN (upper limit of normal)in the absence of liver or bone metastases or ≤5 ULN(in patients with documented bone or liver metastases)
• •* Serum transaminases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) ≤ 2.5 x ULN in the absence of liver metastases or =\< 5 ULN in case of liver metastases)
• •* Total bilirubin ≤1.5 x ULN
• •* Glomerular Filtration Rate ≥ 60 mL/min (according to Modification of the Diet in Renal Disease (MDRD) formula or cockroft \& Gault formula)
• •* Serum albumin ≥ 30 g/L
• •* Effective contraception during the study period and for 3 months after the last study treatment administration (male and female patient)