Table 1 Inclusion and exclusion criteria for participation in the NEOMUN trial
Key inclusion criteria: | Key exclusion criteria: |
|---|---|
Age ≥ 18 years, ECOG status 0–1 | Active autoimmune disease |
History of chronic systemic steroid therapy | |
Histologically confirmed NSCLC | Anticancer treatment < 30 days |
Clinical stage IIA-IIIA according to the TNM classification, 7th edition [20]: (stages IIIA1–3* Robinson classification [36]) | Clinical T4 tumor (according to the 7th edition of the TNM-system [20]) |
Staging by PET/CT and brain magnetic resonance imaging (MRI) | Status post or current pneumonitis that required steroids |
At least 1 measurable lesion according to RECIST 1.1 [13] | Monoclonal antibody-treatment (< 30 days) |
Live vaccination (< 30 days) | |
Targeted small molecule therapy | |
Previous treatment with checkpoint inhibitors | |
Adequate bone marrow function, liver and renal function | Symptomatic acute cardiovascular or cerebrovascular disease |
Evidence of interstitial lung disease | |
Adequate lung and cardiac function for intended lung resection according to German S3 guideline [37] | Psychiatric illness that might affect the patient’s ability to understand the demands of the clinical trial |
Note: subjects of childbearing potential must use an adequate method of contraception | History of allogeneic tissue/solid organ transplant |
Hypersensitivity to Pembrolizumab | |
Known active TBC, HBV, HCV or HIV infection |