A study assessing the combination of TG4010 and nivolumab with standard treatment in patients with advanced non small cell lung cancer.
- Conditions
- Stage IIIB-IV non small cell lung cancer (NSCLC)MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000015841Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-005115-41-HU
- Lead Sponsor
- Transgene S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 39
• 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
• WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug plus 30 days for a total of 5 months post-treatment completion. Highly effective contraception are defined in the protocol.
• Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 90 days for a total of 7 months post-treatment completion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
• 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
• Positive serology for HIV or HCV; presence in the serum of the antigens HBs at baseline
• 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)
• History of any of the following cardiovascular conditions within 12 months of enrollment
• Left ventricular ejection fraction less than the Lower Limit of Normal as assessed by echocardiography (or MUGA scan)
• Patient with major surgery or radiotherapy within 3 weeks prior to the start of the study treatment. However, prior surgery or radiation therapy aimed at local palliation or attempted local disease control (except in case of thoracic radiotherapy) is permitted but has to be completed 2 weeks before treatment start
• Pregnant or nursing (lactating) women
• Patients with an organ allograft
• Any known allergy to eggs, gentamicin or history of allergy or hypersensitivity to study drug components
• Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatments
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method