Electroacupuncture plus immunotherapy after surgery for early non-small cell lung cancer
Observation on the Clinical Efficacy of Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer
This trial tests whether adding electroacupuncture (and in some groups a Zilongjin herbal tablet) to immune checkpoint inhibitor treatment after surgery helps people with stage II–III non‑small cell lung cancer reduce recurrence and live longer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 405 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT07034326 on ClinicalTrials.gov |
What this trial studies
This is a large, multicenter, randomized Phase 2/3 parallel-controlled study comparing immune checkpoint inhibitor (ICI) therapy alone versus ICI combined with electroacupuncture or ICI combined with Zilongjin tablet in patients after curative surgery for stage II–III non‑small cell lung cancer. Eligible participants are adults without actionable driver mutations who have completed 1–4 cycles of postoperative adjuvant chemotherapy and meet traditional Chinese medicine syndrome criteria. The trial will collect safety data and clinical outcomes including recurrence, metastasis, survival, and quality of life measures to determine whether the added therapies improve long-term outcomes. The protocol follows evidence-based standards and aims to produce high-quality randomized data on the effectiveness and safety of combining electroacupuncture and Zilongjin tablet with modern immunotherapy.
Who should consider this trial
Good fit: Adults aged 18–80 with pathologically confirmed stage II, IIIA, or IIIB (N2) non‑small cell lung cancer after complete resection, negative for driver mutations, ECOG 0–2, who have received 1–4 cycles of postoperative adjuvant chemotherapy and meet the study's traditional Chinese medicine syndrome criteria are ideal candidates.
Not a fit: Patients with prior or concurrent other malignancies within 5 years, significant heart/liver/kidney dysfunction, R1/R2 resection requiring postoperative radiotherapy, known driver mutations, pregnancy or lactation, severe allergies, or serious psychiatric disorders are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, adding electroacupuncture and/or Zilongjin tablet to immunotherapy could lower postoperative recurrence risk, prolong survival, and improve quality of life for eligible patients.
How similar studies have performed: Small studies and mechanistic data suggest acupuncture can modulate immune function and relieve symptoms, but large randomized evidence showing it improves cancer recurrence or meaningfully augments immune checkpoint inhibitors is lacking and this combination is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Non-tumor patients with stage Ⅱ, ⅢA, ⅢB (N2) non-small cell lung cancer diagnosed by pathology or cytology after surgery; (2) driver mutations negative patients; (3) Postoperative adjuvant chemotherapy was received for 1 to 4 cycles;(4)conforms to two qi syndrome of traditional Chinese medicine syndrome differentiation diagnosis of patients; (5) aged 18 to 80 years old; (6) expected lifetime \> 6 months; (7) ECOG 0 to 2 points; (8) patients willing to accept this solution treatment, adherence to the good. Exclusion Criteria: * (1) Patients with other malignant tumors in the past or at the same time within 5 years; (2) has a serious heart, liver and kidney damage, or other serious complications; (3) the R1, R2, need after resection, postoperative adjuvant radiotherapy patients; (4) with mental disorders; (5) has a variety of drug allergy, allergic constitution; (6) in pregnancy or lactation women.
Where this trial is running
Tianjin
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Fanming Kong Director of Oncology Department, PhD
- Email: kongfanming08@163.com
- Phone: + 86 22 27986525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.