Comparative Study of Xiaojiyin Combined with Immunotherapy and Chemotherapy versus Immunotherapy and Chemotherapy Alone in Patients with Advanced Non-Small Cell Lung Cancer and Exploration of Related Biomarkers

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Intervention group:Receive the traditional Chinese medicine compound Xiaojie Yin + PD‐1 inhibitor + chemotherapy;Control group:Receive PD‐1 inhibitor + chemotherapy; CONDITION: Advanced non‐small cell lung cancer PRIMARY OUTCOME: Progression free survival; SECONDARY OUTCOME: Overall survival;Objective response rate;Two‐year survival rate; INCLUSION CRITERIA: 1. Patients who voluntarily participate in the study and have signed a written informed consent form. 2. Patients with untreated advanced non‐small cell lung cancer who were 18 years of age or older at the time of signing the informed consent form. 3. Patients with negative EGFR and ALK testing. 4. No history of malignant tumors in the past five years. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 1. 6. Expected survival period >=12 weeks. 7. Measurable or evaluable local or metastatic lesions. 8. Subjects without significant dysfunction of major organs, with baseline assessments of blood routine, thyroid, lung, liver, kidney function, and cardiac function evaluated as essentially normal by the investigator. 9. Women of childbearing potential must have already implemented reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment.
Epistemonikos ID: b53937dbf9665de73b38e92b29898bd393af2240
First added on: Oct 08, 2026