Inclusion Criteria:
- Signed informed consent
- Age ≥ 18 years
- Histologically or cytologically confirmed advanced NSCLC (adenocarcinoma, squamous
cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
- Advanced NSCLC cancer patient with progressive disease after a first line of combo
chemotherapy plus anti-PD-1 or chemotherapy plus anti-PD-L1 combination
- Measurable disease defined according to iRECIST v1.1 guidelines
- Patients must have a mandatory treatment-free interval of at least 21 days following
previous systemic anti-cancer treatments
- Patients who have received previous systemic anticancer treatment and/or radiotherapy
should have recovered from any treatment related toxicity, to a level of ≤ grade 1
with the exception of Grade 2 alopecia
- Performance status 0 or 1 on the ECOG scale
- Females must be using highly effective contraceptive measures and have a negative
pregnancy test prior to the start of dosing if of childbearing potential, or must have
evidence of non-childbearing potential. Females of childbearing potential should use
reliable methods of contraception from the time of the screening until 5 months after
discontinuing study treatment. Male patients with a female partner of childbearing
potential should be willing to use barrier contraception during the study and for 7
months following discontinuation of study drug. Patients should refrain from donating
sperm from the start of dosing until 7 months after discontinuing study treatment.
- Registration in a national health care system.
- Ability to comply with the study protocol, in the Investigator's judgment
Exclusion Criteria:
- Diagnosis of additional malignancy within 2 years prior to the inclusion with the
exception of curatively treated basal cell carcinoma of the skin and/or curatively
resected in situ cervical or breast cancer
- Patient with any medical or psychiatric condition or disease, which would make the
patient inappropriate for entry into this study
- Participation in a clinical study with an investigational product within 4 weeks prior
to the start of the study treatment
- Patient under guardianship, curatorship or under the protection of justice
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
- Known active central nervous system metastases and/or carcinomatous meningitis
- Uncontrolled brain metastases
- Presence of EGFR mutation, ALK or ROS1 translocation
- history of hyperprogression during first line treatment with chemotherapy plus
immunotherapy
- Inadequate organ functions: known cardiac failure of unstable coronaropathy,
respiratory failure, or uncontrolled infection or another life-risk condition
- Active or chronic hepatitis B or C and/or HIV positive or known history of active
Covid-19 infection, or a known history of active Tuberculosis bacillus
- Any immunosuppressive therapy (i.e. corticosteroids >10mg of hydrocortisone or
equivalent dose) within 14 days before the planned start of study therapy
- Active autoimmune disease that has required a systemic treatment in past 2 years (i.e.
corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine,
insulin) is allowed
- Active or history of autoimmune disease or immune deficiency
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to Chinese hamster ovary cell products or any
component of Nivolumab formulation
- History of idiopathic or secondary pulmonary fibrosis or evidence of active
pneumonitis requiring a systemic treatment with 28 days before the planned start of
study therapy
- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation
of study treatment, or anticipation of need for a major surgical procedure during the
course of the study
- Severe infection within 4 weeks prior to initiation of study treatment, including, but
not limited to, hospitalization for complications of infection, bacteremia, or severe
pneumonia
- Treatment with therapeutic oral or IV antibiotics within 4 weeks prior to initiation
of study treatment
- Receipt of a live, attenuated vaccine within 4 weeks prior to the initiation of
treatment or anticipation that such a live, attenuated vaccine will be required during
the study
- Patients requiring oxygen therapy
- For patients with a known cardiac history or with cardiac events occurring after
first-line chemoimmunotherapy: LEVF<40% ; troponin > ULN; BNP > ULN
- Inadequate hematology, hepatic, renal functions or others inadequate laboratory values