A 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)

Principal Inclusion Criteria:

- 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 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 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 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 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