Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer (VinMetAtezo)

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring immunotherapy, second line of chemotherapy Read More

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.