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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Fanming Kong, PhD
• Email: kongfanming08@163.com
• Phone: +86 22 27986525

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.