Electro-acupuncture Plus PD-1 Inhibitors and Chemotherapy as First-Line Treatment for Metastatic Non-Small Cell Lung Cancer: A Randomized Trial
This multicentre, randomized controlled trial evaluates the effect and safety of acupuncture combing with PD-1 inhibitors plus chemotherapy in NSCLC. Participants will be randomly assigned to undergo either acupuncture or sham acupuncture concurrent with the initial four-six cycles of chemotherapy combined with PD-1 inhibitors.
• Pathologically confirmed NSCLC, with AJCC lung cancer TNM stage IV.
• Tumor proportion score for PD-L1 \< 50%.
• Lacks targetable gene mutations (including but not limited to EGFR mutations or ALK fusions).
• No prior systemic therapy for advanced NSCLC (including chemotherapy, targeted therapy, or immunotherapy). Patients planned to receive first-line (induction) treatment with ICIs plus chemotherapy are eligible. Patients who have received prior neoadjuvant or adjuvant therapy, or definitive chemoradiotherapy, may be enrolled if provided that disease progression occurred more than 6 months after the completion of the last treatment.
• ECOG performance status score of 0-2.
• Age ≥ 18 years.
• At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Adequate organ function (hematology: ANC ≥ 1500/mcL, PLT ≥ 100,000/mcL, Hb ≥ 9.0 g/dL or ≥ 5.6 mmol/L; renal function: estimated creatinine clearance ≥ 50 mL/min; hepatic function: serum total bilirubin ≤ 1.5 × ULN or total bilirubin \> 1.5 × ULN with direct bilirubin ≤ ULN, AST and ALT ≤ 2.5 × ULN ≤ 5 × ULN for patients with liver metastases).
• Voluntary participation in the study, signed informed consent form, good compliance, and cooperation with follow-up.