Electroacupuncture plus PD‑1 immunotherapy for advanced non‑small cell lung cancer with ECOG 2

The Clinical Efficacy of Electroacupuncture Combined With PD-1 Inhibitor in the Treatment of ECOG2 Advanced Non-small Cell Lung Cancer

This trial will see if adding electroacupuncture to PD‑1 immunotherapy helps people with advanced non‑small cell lung cancer who have an ECOG performance status of 2.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07239661 on ClinicalTrials.gov

What this trial studies

This randomized, sham‑controlled clinical trial enrolls patients with stage IIIb–IV NSCLC and ECOG PS 2 who receive standard PD‑1 inhibitor therapy. Participants are randomized 1:1 to receive either electroacupuncture plus PD‑1 inhibitor or sham electroacupuncture plus PD‑1 inhibitor, with immunotherapy given every 21 days for four to six cycles and maintenance as clinically appropriate. Electroacupuncture is started on the first day of each immunotherapy cycle and delivered daily during treatment periods, while outcomes include progression‑free survival, immune biomarkers, symptom burden and quality of life. The trial uses blinded sham procedures to control for placebo effects and aims to provide evidence on whether adding a standardized traditional Chinese medicine approach can meaningfully affect clinical and immunologic outcomes in this frail population.

Who should consider this trial

Good fit: Ideal candidates are adults with stage IIIb–IV NSCLC, negative for common driver mutations, PD‑L1 TPS ≥1%, an ECOG performance status of 2, expected survival over three months, and willingness to undergo acupuncture and immunotherapy.

Not a fit: Patients with actionable driver mutations, ECOG scores much higher or lower than 2, very limited life expectancy, or who cannot tolerate immunotherapy or acupuncture are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could extend progression‑free survival and improve immune function and quality of life for patients with advanced NSCLC who are ECOG 2.

How similar studies have performed: Small trials and mechanistic studies suggest acupuncture can improve symptoms and modulate immune markers, but large randomized trials combining electroacupuncture with PD‑1 inhibitors in advanced NSCLC are largely lacking.

Eligibility criteria

Inclusion Criteria:

* Patients diagnosed with stage ⅢB-Ⅳ non-small cell lung cancer (NSCLC) confirmed by pathological or cytological examination;
* Patients with negative driver gene mutations, excluding those harboring EGFR mutations, ALK rearrangements, or other common driver gene alterations as determined by genetic testing or other molecular biological methods;
* An Eastern Cooperative Oncology Group (ECOG) performance status score of 2;
* A programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥ 1%;
* An expected survival time of more than 3 months, as assessed by the clinician based on the patient's overall condition, tumor progression, and response to treatment;
* Patients with good treatment compliance who provided written informed consent, confirming their understanding of and willingness to undergo treatment and follow-up according to the study protocol.

Exclusion Criteria:

* Patients with a history or concurrent diagnosis of other malignant tumors within the past five years;
* Patients with severe organ impairment or serious comorbidities, such as cardiac dysfunction (New York Heart Association \[NYHA\] class Ⅲ-Ⅳ), hepatic or renal insufficiency, as determined by standard clinical examinations including liver and kidney function tests and electrocardiography;
* Patients with untreated central nervous system (CNS) metastases were excluded; eligible patients were required to have stable disease confirmed by imaging after receiving at least one systemic or surgical treatment;
* Patients with psychiatric disorders, including schizophrenia or bipolar disorder, particularly those requiring pharmacologic treatment;
* Patients with a history of multiple drug allergies, an allergic predisposition, or a history of severe allergic reactions such as anaphylactic shock or allergic rash;
* Subjects with active autoimmune or infectious diseases, including but not limited to chronic viral hepatitis, active pulmonary tuberculosis, or other infections or autoimmune disorders deemed by clinicians to potentially affect the study;
* Female patients who were pregnant or lactating.

Where this trial is running

Tianjin, Tianjin Municipality

• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Fanming Kong, PhD

Conditions Non-Small Cell Lung Cancer; Electroacupuncture; PD-1 Inhibitors; ECOG PS 2 Points; electroacupuncture; Immunotherapy; immune checkpoint inhibitor; ECOG PS 2 points