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Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC
Bu çalışma, ameliyatla çıkarılabilir evre IIIA-IIIB küçük hücreli dışı akciğer kanseri (non-small cell lung cancer) hastalarında, ameliyat öncesi (neoadjuvan) Camrelizumab ile kemoterapi kombinasyonunun etkisini incelemektedir. Çalışmaya, 18-75 yaş arası, EGFR, ALK ve ROS1 mutasyonu taşımayan hastalar alınmaktadır. Çalışma Faz 2 aşamasında yürütülmekte ve halen katılımcı almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Age 18-75 * Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC * Absence of EGFR, ALK, and ROS1 gene mutations * Eastern Cooperative Oncology Group (ECOG) status 0-1 * Signed written informed consent prior to the implementation of any trial-related rocedures * Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy: Absolute neutrophil count ≥ 1,500 х109/L, Thrombocytes ≥ 100 х 109/L, Hemoglobin ≥ 90 mg/L, Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 mL/min, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) \> 5 x ULN, Bilirubin \> 1.5 х ULN Exclusion Criteria: * Patients diagnosed with any other malignant tumor * Have received prior therapy with chemotherapy or immune checkpoint inhibitor * Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding * Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment * Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction * A history of interstitial lung disease or non-infectious pneumonia * Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years * Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections * Patients who have received allogeneic stem cell or solid organ transplantation * Women during pregnancy or lactation