Electroacupuncture plus PD-1 immunotherapy for older adults with advanced non-small cell lung cancer

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 is a randomized, controlled clinical design comparing electroacupuncture plus a PD‑1 inhibitor to sham electroacupuncture plus the same PD‑1 inhibitor in elderly patients with stage IIIB–IV non‑small cell lung cancer. Participants must be aged 65 or older, PD‑L1 TPS ≥1%, have no common driver mutations, and have ECOG 0–2 with expected survival over three months. The trial will measure clinical efficacy and safety outcomes and will collect immune and biomarker data to explore how electroacupuncture might modulate the tumor immune microenvironment. Treatments follow standard PD‑1 inhibitor dosing while acupuncture or sham procedures are delivered according to the trial protocol.

Why it matters

Who can join: the full rules

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.

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.