Electroacupuncture Combined With PD-1 Inhibitor for Elderly Patients With Advanced NSCLC

Launched by KONG FANMING · Jul 18, 2025

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ClinConnect Summary

This clinical trial is studying whether adding electroacupuncture—a type of acupuncture that uses a small electric current—can improve treatment outcomes when combined with a PD-1 inhibitor, a type of immunotherapy, in elderly patients (65 years and older) with advanced non-small cell lung cancer (NSCLC). The goal is to see if this combination can help patients live longer without their cancer getting worse, improve their quality of life, and be safe to use. Researchers will compare two groups of patients: one receiving the real electroacupuncture plus the immunotherapy, and the other receiving a fake (sham) electroacupuncture plus the immunotherapy, to find out if the real treatment offers additional benefits.

To join the trial, patients need to have advanced lung cancer that has been confirmed by tests, be 65 years or older, and have certain characteristics of their cancer that make them suitable for PD-1 inhibitor treatment. Patients must be generally well enough to participate, with an expected survival time of more than three months and no serious other health problems like severe heart or kidney issues. During the study, participants will receive the PD-1 inhibitor every three weeks for several cycles, along with electroacupuncture treatments five times per cycle. The study will also look at patients’ immune health and quality of life. Importantly, blood samples will be collected to help researchers understand which patients might benefit most from this combined treatment. If you or a loved one fits these criteria and are interested, this trial might be an option to consider alongside your healthcare team.

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Eligibility criteria

• Inclusion Criteria:
• • Patients with stage IIIB-IV non-small cell lung cancer (NSCLC) confirmed by histopathological or cytological diagnosis.
• • Patients with negative driver gene mutations, as determined by genetic testing or other molecular biological methods, to exclude common driver mutations such as EGFR mutations and ALK rearrangements.
• • Patients aged ≥65 years, with consideration for the patients' overall physical condition. Additional assessments will be conducted if there are comorbidities or other factors that may affect their physical status.
• • PD-L1 tumor proportion score (TPS) ≥1%.
• • Estimated survival time \>3 months, as determined by clinical evaluation based on the patient's overall condition, tumor progression, and response to treatment.
• • ECOG performance status score of 0-2.
• • Patients with good treatment compliance, who are willing to sign an informed consent form, indicating their understanding and agreement to adhere to the study protocol for treatment and follow-up.
• Exclusion Criteria:
• • Patients with a history of or concurrent other malignancies within the past 5 years.
• • Patients with severe organ dysfunction or other serious comorbidities, such as heart failure (NYHA Class III-IV), hepatic or renal insufficiency, as assessed by routine examinations including liver function tests, renal function tests, and electrocardiograms.
• • Patients with untreated central nervous system metastases. Only those who have undergone at least one course of systemic or surgical treatment and have been confirmed to have stable disease by imaging studies will be included.
• • Patients with psychiatric disorders, including a history of severe mental illnesses (e.g., schizophrenia, bipolar disorder) that require pharmacological treatment for control.
• • Patients with a history of multiple drug allergies or an allergic constitution, particularly those who have experienced severe allergic reactions such as anaphylactic shock or allergic rashes.
• • Patients with active autoimmune diseases or infectious diseases, including but not limited to active or chronic viral hepatitis, active pulmonary tuberculosis, or other infectious or autoimmune conditions deemed by the clinical investigator to potentially affect the study.
• • Patients who are pregnant or breastfeeding.