Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Transgene
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
Patients having Central Nervous System (CNS) metastases. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed
* Other cancer curatively treated with no evidence of disease for at least 5 years
Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (e.g., cyclosporine) for a period of at least 4 weeks and whose treatment was not stopped 1 week prior to the start of the study treatment (i.e., D1 of Cycle 1)
Positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV); presence in the serum of the antigens HBs
Patient with any underlying medical condition that the treating physician considers might be aggravated by treatment or which is not controlled (e.g., elevated troponin or creatinine, uncontrolled diabetes)
Patient with major surgery or radiotherapy within 4 weeks prior to the start of the study treatment (i.e., D1 of Cycle 1). Prior surgery or radiation therapy aimed at local palliation or attempted local disease control is permitted
Patient with an organ allograft
Known allergy to eggs, gentamicin or platinum-containing compounds
Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment (i.e., D1 of Cycle 1)
Patient unable or unwilling to comply with the protocol requirements
Pregnancy or lactation
Bevacizumab will be allowed for patients with non-squamous carcinoma. Prescribing information must be followed and precautions have to be taken into consideration (e.g., patients having presented a serious hemorrhage or recent hemoptysis should not receive bevacizumab).
Clareo Health | Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer
