OncoMatch/Clinical Trials/NCT06445881
Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment
Is NCT06445881 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Modified Si Jun Zi Tang for non small cell lung cancer.
Treatment: Modified Si Jun Zi Tang — Chemotherapy combined with immunotherapy is the current standard perioperative treatment for non-small cell lung cancer (NSCLC). However, this regimen has multiple side effects and shows variable efficacy among individuals. In China, adjunctive traditional Chinese medicine is widely accepted by lung cancer patients. Modified Si Jun Zi Tang, a classic formula in traditional Chinese medicine, is known for its benefits in unifying and strengthening the spleen. This study aims to evaluate whether the addition of Modified Si Jun Zi Tang to chemotherapy and immunotherapy during the neoadjuvant phase can improve the R0 resection rate, objective response rate (ORR), and safety in patients with resectable and potentially resectable NSCLC. Secondary objectives include assessing whether this combination can improve 1-year and 2-year disease-free survival (DFS) post-surgery. Additionally, we will collect relevant biological samples to identify tumor markers associated with efficacy, prognosis, and side effects, providing a theoretical basis for modernizing and standardizing traditional Chinese medicine.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Disease stage
Required: Stage II, IIIA, IIIB (N2)
Clinical stage II-IIIB (N2) tumors assessed as resectable or potentially resectable by a multidisciplinary team (MDT)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PD-1/PD-L1 inhibitor
Previous use of PD-1/PD-L1 inhibitors or other anti-tumor immunotherapy drugs
Cannot have received: anti-tumor immunotherapy
Previous use of PD-1/PD-L1 inhibitors or other anti-tumor immunotherapy drugs
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L, platelets ≥ 80 x 10^9/L, hemoglobin ≥ 90 g/L
Kidney function
Creatinine clearance rate ≥ 45 mL/min (Cockcroft-Gault) or ≤ 1.5 times ULN
Liver function
Total bilirubin ≤ 1.5 times ULN, AST/ALT ≤ 3 times ULN
Adequate organ function, including: Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥ 80 x 10^9/L, hemoglobin ≥ 90 g/L. Liver: Total bilirubin ≤ 1.5 times ULN, AST/ALT ≤ 3 times ULN. Kidneys: Creatinine clearance rate ≥ 45 mL/min (Cockcroft-Gault) or ≤ 1.5 times ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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