A phase II study evaluating the efficacy and the safety of first-line chemotherapy combined with TG4010 and nivolumab in patients with advanced non-squamous Non-Small-Cell Lung Cancer (NSCLC)

Transgene S.A.0 sites44 target enrollmentJune 20, 2017

Overview

No summary available.

Registry

who.int

Start Date

June 20, 2017

End Date

November 2, 2020

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Transgene S.A.

•Female or male patients age \> 18 years\-old
•ECOG performance Status 0 or 1 at study entry
•Life expectancy of at least 3 months
•Histologically confirmed non\-squamous NSCLC (adenocarcinoma, large cell carcinoma, undifferentiated carcinoma or other)
•Stage IIIB\-IV cancer or delayed relapse of any stage not amenable to surgery or radiotherapy with curative intent.
•PD\-L1 expression by immunohistochemistry in \< 50% of tumor cells
•Patients must be chemotherapy\-naïve for the advanced stage of the disease. Previous neoadjuvant and/or adjuvant chemotherapy 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.
•At least one measurable lesion by CT scan based on RECIST 1\.1 performed within 28 days prior to start of study treatment
•Adequate hematological, hepatic, and renal functions
•Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to the start of study drug

•Patients having CNS metastases
•Patients with pericardial effusion
•Prior exposure to cancer immunotherapy including cancer vaccines, anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-cytotoxic T\-Lymphocyte antigen\-4 antibody or any other antibody or drug specifically targeting T\-cell co\-stimulation or checkpoint pathways
•Patients with EGFR activating mutations or ALK\- rearrangements leading to eligibility for TKI treatment (tests mandatory)
•Prior history of other malignancy except basal cell carcinoma of the skin, cervical intra epithelial neoplasia, and other cancer curatively treated with no evidence of disease for at least 3 years
•Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
•Patients with an active, known or suspected autoimmune disease
•Patient with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug\-related pulmonary toxicity
•Patients with grade \= 2 neuropathy
•Signs or symptoms of infection within 14 days prior to start of study treatment or active infection requiring systemic therapy