microbioma Non small cell lung carcinoma
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Stages IIIA, IIIB and IIIC (as per UICC 8th TNM edition) NSCLC (histologically or cytologically confirmed) amenable for concurrent chemoradiotherapy according to multidisciplinary tumor board. 2. No signs of disease progression after Chemoradiation (sequential and concurrent) 3. At least 1 cycle of chemotherapy as part of the radiotherapy schedule but no more chemotherapy between last radiotherapy session and start durvalumab 4. Absence of any of following targetable driver mutations: (EGFR, ALK, ROS1) 5. >= 18 years 6. ECOG
Exclusion criteria
Exclusion criteria: 1. 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. 2. Has had prior monoclonal antibody therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e., 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration 6. Has evidence of symptomatic interstitial lung disease or an active, non-infectious pneumonitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of disease defined by regular CT scan and physical examination and occurrence of toxicity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in circulating immune cells. | — |
Countries
Netherlands
Outcome results
None listed