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

NCT ID: NCT07034326

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electroacupuncture combined with immunotherapy

Group Type: EXPERIMENTAL

Electroacupuncture combined with immunotherapy

Intervention Type: 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.

Zilongjin tablet combined with immunotherapy

Group Type: EXPERIMENTAL

Zilongjin tablet combined with immunotherapy

Intervention Type: 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.

Immunotherapy

Group Type: ACTIVE_COMPARATOR

Immunotherapy

Intervention Type: 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.

Interventions

Electroacupuncture combined with immunotherapy

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.

Intervention Type: OTHER

Zilongjin tablet combined with immunotherapy

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.

Intervention Type: DRUG

Immunotherapy

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

Sponsor Role: collaborator

Kong Fanming

OTHER

Sponsor Role: lead

Responsible Party

Kong Fanming

Director of Oncology Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Fanming Kong Director of Oncology Department, PhD

Role: CONTACT

kongfanming08@163.com

+ 86 22 27986525

Facility Contacts

Fanming Kong Fanming Kong, PhD

Role: primary

kongfanming08@163.com

+ 86 22 27986525

Other Identifiers

TYLL2024[Z]082

Identifier Type: -

Identifier Source: org_study_id