Clinical Research Directory

Inclusion Criteria: * Histologically confirmed NSCLC; * Locally advanced and/or metastatic stage IV NSCLC (according to American Joint Committee on Cancers) or recurrent NSCLC); * Patients without activating EGFR mutation or ALK rearrangement and ROS1 fusions. * Subject has provided a formalin-fixed tumor-tissue sample of a tumor-lesion biopsy, either at the time of or after metastatic disease was diagnosed AND from a site not previously irradiated to assess for PDL1 status. Archived tissue may be acceptable or PDL1 status known; * Progressive disease after first-line platinum-doublet-based chemotherapy according to RECIST V.1.1 with measurable lesion (RECIST V1.1); * Age ≥18 years, either sex; * Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2; * Life expectancy exceeds 12 weeks; * No history of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the skin; * Adequate organ function, demonstrated by the following laboratory results within 3 weeks prior to teatment: Normal hepatic function: bilirubin \<1.5 × normal (N), Alanine aminotransferase and Aspartate aminotransferase \<2.5 × N or \<5 × N if liver metastasis is present; * Normal renal function (calculated creatinine clearance ≥45 mL/min); * Normal calcemia; * Normal hematological function (polynuclear neutrophils \>1.5 G/L, platelets \>100 G/L and hemoglobin\>8g/dl); * Women of child-bearing potential must use effective contraception; * Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment; * Written informed consent to participate in the study * Patient with social insurance Exclusion Criteria: * ECOG PS \>2; * Known hypersensitivity to immunotherapy; * Small-cell lung cancer, bronchioloalveolar cancer, neuroendocrine cancer; * Tumor harbors EGFR-sensitizing (activating) mutations or ALK translocations or ROS1 fusions and that justify treatment with targeted therapy ; * Chemotherapy, hormonotherapy, immunotherapy or tyrosine-kinase inhibitors within the past 4 weeks prior to treatment with the trial drug; * Radiotherapy (except bone or brain) within the past 3 months prior to baseline imaging; * Medical contraindication to oral vinorelbine; * Persistence of clinical adverse events with a grade \> 2 related to prior treatment; * Active brain metastases (e.g. stable for \<4 weeks, no adequate previous radiotherapy, symptomatic, requiring anticonvulsants or corticosteroids) * Concurrent radiotherapy, except for palliative bone irradiation. * Other concurrent severe illnesses (congestive heart failure, unstable angina, significant arrhythmia or myocardial infarction \<12 months before study entry); * Active or prior documented autoimmune or inflammatory disorders; * Active B hepatitis, HIV infection …; * Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial; * Grade-3 peripheral neuropathy; * Uncontrolled infection; * Interstitial lung disease or pneumonitis requiring steroid management; * Corticosteroid therapy exceeding 10 mg/day; * Other severe organic disorders not allowing inclusion in the trial; * Malabsorption syndrome; * Pregnancy or breast-feeding; * Follow-up not possible; and incarcerated or institutionalized patients.