Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer

NCT07034326 | Recruiting Phase 2 DMC

• 1 other identifier: TYLL2024[Z]082
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative immunoadjuvant therapy has been proven to significantly reduce the risk of recurrence after resectable NSCLC, and has become a new standard of postoperative adjuvant therapy for stage II-III NSCLC. Immunotherapy faces challenges such as immune resistance, heterogeneity of biomarker expression, and limitation of immune-suitable population. How to reduce the rate of recurrence and metastasis after surgery, enhance the therapeutic effect of immunotherapy, and then prolong the survival period and improve the quality of life, has become an urgent problem facing the current clinical. Based on the standards of evidence-based medicine, this study for the first time carried out a large sample, multi-center, randomized parallel controlled clinical study to obtain high-quality clinical evidence of the effectiveness and safety of electro-acupuncture and Zilongjin tablet synergic treatment, and formed a standard treatment plan of traditional Chinese medicine.

Conditions

Non-Small Cell Lung Cancer; Electroacupuncture; Immune Checkpoint Inhibitors

Outcome Measures

Primary Outcomes (1)

• Disease free survival(DFS)

  Time from random start to first recurrence or death.

  2year

Secondary Outcomes (5)

• DFS

  3year

• Overall survival

  3,5year

• EORTC QLQ-C30 Scale

  0,2,3,6 month

• Immune function

  0,3 month

• Lung cancer TCM syndrome score

  0,2,3,6 month

Study Arms (3)

Electroacupuncture combined with immunotherapy

EXPERIMENTAL

Other: Electroacupuncture combined with immunotherapy

Zilongjin tablet combined with immunotherapy

EXPERIMENTAL

Drug: Zilongjin tablet combined with immunotherapy

Immunotherapy

ACTIVE COMPARATOR

Drug: Immunotherapy

Interventions

Electroacupuncture combined with immunotherapy OTHER

Connect the electroacupuncture therapy instrument, select the density wave 2 Hz/100 Hz, the current intensity should be tolerated by the patient, leave the needle for 20 min.Immunotherapy including but not limited to pabolizumab and attilizumab were repeated every 21 days for treatment weeks.The period is 1 year, and maintenance treatment can be carried out in accordance with the drug instructions and guidelines.

Electroacupuncture combined with immunotherapy

Zilongjin tablet combined with immunotherapy DRUG

Take Zilongjin tablets orally, 4 tablets each time, 3 times a day.Immunotherapy including but not limited to pabolizumab and attilizumab were repeated every 21 days for treatment weeks.The period is 1 year, and maintenance treatment can be carried out in accordance with the drug instructions and guidelines.

Zilongjin tablet combined with immunotherapy

Immunotherapy DRUG

Immunotherapy including but not limited to pabolizumab and attilizumab were repeated every 21 days for treatment weeks.The period is 1 year, and maintenance treatment can be carried out in accordance with the drug instructions and guidelines.

Immunotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Kong Fanming: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (1)

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, 300381, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Fanming Kong Director of Oncology Department, PhD

CONTACT

+ 86 22 27986525; kongfanming08@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Oncology Department

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 24, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)