The predictive value of the microbiome (throat swabs, stool and of bronchial samples) to identify patients who will relapse during durvalumab treatment after CRT (False negative Rate) at 6 months. Exploratory endpoints include the effects of antibiotic therapy before and during IO treatment on toxicity and response rate. The role of exhaled breath analysis in prediction of response and toxicity will also be investigated.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Stages IIIA, IIIB and IIIC (as per UICC 8th TNM edition) NSCLC (histologically or cytologically confirmed) amenable for durvalumab treatment after sequential or concurrent chemoradiotherapy according to local standards. Patients that received neoadjuvant/adjuvant chemotherapy for surgically treated stages I to III NSCLC are allowed as long as therapy was completed at least 6 months prior to the diagnosis of disease recurrence amenable for chemoradiotherapy and resolution of all treatment related toxicity ≤ grade 1 .
✓. No signs of disease progression after CCRT
✓. At least 1 cycle of chemotherapy before or concurrent during radiotherapy but no more chemotherapy between last radiotherapy session and start durvalumab
✓. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
✓. Absence of any of following targetable driver mutations: EGFR, ALK, ROS1
✓. over 18 years
✓. ECOG 0-1
✓. Must be willing to provide collected stool samples and allow to obtain a throat swab during the observation period. A pulmonary protected brush swab will only be optionally performed in a selected number of patients.
Exclusion criteria
✕. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
✕
What they're measuring
1
Prediction of outcome (progression) based on microbiome analysis
. Has had prior monoclonal antibody therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
✕. Previous treatment with PD-1-PD-L1 axis inhibiting immunotherapy.
✕. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
✕. Subjects who have undergone organ transplant or allogeneic stem cell transplantation.
✕. Active malignancy or a prior malignancy within the past 3 years, with the following exceptions:
✕. Subjects with chronic infections/infectious disorders (eg. Clostridium colitis)