A Phase IIb/III randomized, double-blind, placebo-controlled study comparing first-line therapy with or without TG4010 immunotherapy product in patients with stage IV non-small cell lung cancer (NSCLC).

Transgene S.A.0 sites222 target enrollmentSeptember 19, 2011

Overview

No summary available.

Registry

who.int

Start Date

September 19, 2011

End Date

July 6, 2015

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Transgene S.A.

•\- Male or female patients, age ? 18 years old
•\- Histologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
•\- Stage IV cancer according to TNM classification
•\- Tumor biopsy specimen with ? 25% 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
•\- 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 computorized tomography scan or magnetic resonance imaging based on RECIST version 1\.1 (CT is preferred for the chest exam)
•\- Performance status 0 or 1 on the ECOG scale
•\- Adequate hematological, hepatic, and renal function:
•\* Hemoglobin ? 10\.0 g/dL
•\* White Blood Cells ? 3\.0x1E\+09/L including:

•\- Patients having Central Nervous System metastases. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed
•\- Documented EGFR activating mutations (if already tested)
•\- Prior history of other malignancy except:
•\* Basal cell carcinoma of the skin
•\* Cervical intra epithelial neoplasia
•\* 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 or Hepatitis C Virus; 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