Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2025-12-24 @ 7:54 PM
NCT ID:
NCT03801304
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03801304
Study Brief:
Protocol Section:
NCT03801304