A Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With the Therapeutic Vaccine Named TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)

Transgene

Status and phase

Completed

Phase 2

Conditions

Non Small Cell Lung Cancer Metastatic

Treatments

Biological: TG4010

Drug: Nivolumab

Drug: Chemotherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT03353675

TG4010.24

Details and patient eligibility

About

This is a multicenter, single arm, open label phase II study in treatment-naïve for advanced stage of the disease and immunotherapy-naïve patients with advanced non-squamous NSCLC and with < 50% of tumor cells expressing programmed death-ligand 1 (PD-L1) by immunohistochemical (IHC) staining.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Principal Inclusion Criteria:

Female or male patients age > 18 years-old
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 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 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 posttreatment 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

Principal Exclusion Criteria:

Patients having central nervous system (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 costimulation or checkpoint pathways
Patients with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)- rearrangements leading to eligibility for tyrosine kinase inhibitor (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 hepatitis C virus (HCV); presence in the serum of the antigens hepatitis B (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 cardiovascular conditions within 12 months of enrollment
Left ventricular ejection fraction less than the Lower Limit of Normal as assessed by echocardiography (or multigated acquisition (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