Studieoverzicht
Study name: NEOpredict
Histology | NSCLC |
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Tumor stage | Stage I - III |
Host / recruiting sites | Antoni van Leeuwenhoek |
Enrollment | Recruiting |
Therapy line | First line (1L) |
Design |
This is an international, multicenter, open-label, randomized, three-armed, modular phase II study. Patients with histologically confirmed non-small cell lung cancer (NSCLC) of clinical stages I B, II and selected stage III A (T3 N1, T4 with satellite nodule in the same lung N0/N1, selected T1a-T2b N2 cases considered suitable for primary surgical approach by the multidisciplinary tumor board), who are eligible for anatomic resection will be included. Subjects in all arms will receive 2 preoperative treatment cycles with a cycle duration of 14 days. Study treatment consists of nivolumab q2w in Arm A, and nivolumab q2w plus relatlimab q2w in Arms B and C. |
Intervention | Arm C: Nivolumab/Relatlimab (240 mg) 2 cycles, every two weeks (q2w) o nivolumab 240 mg i.v. over 30 min o relatlimab 240 mg i.v. over 30 min (within 30 min of nivolumab) |
Key inclusion criteria | Patients with histologically (core biopsy) or cytologically (e.g. bronchoscopy-guided biopsy) confirmed non-small cell lung cancer (NSCLC) eligible for anatomic resection, with the following specifications:
Exclusion of extensive mediastinal lymph node metastases (multilevel N2, N3) by PET/CT and/or mediastinal lymph node sampling by EBUS-TBNA and/or staging mediastinoscopy. Exclusion of distant metastases by standard of care imaging studies, which include but are not limited to PET/CT or PET/MRI, or CT or MRI of thorax, abdomen, pelvis, and bone scan. Asymptomatic brain metastases will be excluded by MRI or contrastenhanced CT as indicated by current guidelines |
Key exclusion criteria | Subjects are to be excluded from the study if they display any of the following criteria: • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with the following conditions are not excluded from participation:
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. |
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