Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer

Effectiveness of Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer：A Randomized Controlled Clinical Study

This study will be an evaluation of the efficacy and safety of acupuncture to enhance the response rate of immunotherapy in advanced lung cancer. The main questions it aims to answer are 1. Does acupuncture heighten the response rate of immunotherapy in advanced lung cancer? 2. Does acupuncture heighten the safety of immunotherapy in advanced lung cancer? Researchers will compare acupuncture to sham acupuncture to see if acupuncture could enhance the response rate of immunotherapy in advanced lung cancer. Both groups will receive a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy), and the experimental and control groups will be treated with 4 cycles of acupuncture or sham-acupuncture on top of the anti-tumor treatment regimen, respectively. Patients were followed up every three weeks for the first three months and every three months thereafter to record any disease progression, adverse events, survival or mortality status, and so on.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancers
• Intervention / Treatment: Device: Acupuncture; Device: Sham Comparator

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiarong Fan; Phone Number: 86+88001196; Email: fjrr1115@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Zhu; Phone Number: 86+055162923102; Email: ayfykyc@126.com
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine
      • Contact: Jiarong Fan; Phone Number: 86+88001196; Email: fjrr1115@163.com
  • Hunan
    • Changsha, Hunan, China, 410006
      • Recruiting
      • Hunan Provincial Integrated Traditional Chinese and Western Medicine Hospital
      • Contact: Jian; Phone Number: 86+13469047364

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Age 18-75 years;
• ECOG/PS score of grade 0-1 and expected survival ≥ 3 months;
• Non-small cell lung cancer AJCC lung cancer staging of stage IIIB-IV, or small cell lung cancer staging of extensive stage;
• PD-L1 immunohistochemistry detection of tumor cell positive proportion score (TPS) <50%;
• Non-small cell lung cancer adenocarcinoma patients do not have EGFR-sensitive mutations, ALK fusions, ROS1 fusions, BRAFV600 mutations, NTRK fusions, RET fusions, MET14 skipping mutations, and amplified gene-driven mutations by genetic testing;
• Patients with no previous systemic therapy/first-line treatment;
• Patients suitable for chemotherapy combined with immunotherapy;
• Traditional Chinese Medicine (TCM) diagnosis of Qi Depression;
• Having at least 1 measurable tumor lesion (diameter > 1cm) or lymph node short diameter ≥ 1.5cm;
• Sign the informed consent form and voluntarily participate in this study.

Exclusion criteria:

• Combined with other primary malignant tumors;
• Those who have contraindications to immunotherapy after basic assessment of immunotherapy;
• Those with autoimmune diseases or those who need long-term treatment with systemic steroids or immunosuppressants;
• Those with combined serious and uncontrolled primary diseases of heart, cerebrovascular, liver, kidney, hematopoietic system and so on;
• Those with metal allergy or severe fear of needles;
• Those who are pregnant or breastfeeding;
• Those who are unable to cooperate to complete the assessment due to mental disorder, intellectual or language impairment;
• Those with active severe infectious or inflammatory diseases;
• Those who have received acupuncture treatment or other clinical trials within 1 month prior to randomization;
• In the judgment of the investigator, persons who have a concomitant medical condition that seriously jeopardizes the safety of the participant or interferes with the completion of the study, or who are deemed to have other reasons for not being suitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture	Device: Acupuncture; Both groups have a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy); the acupuncture group is combined with acupuncture treatment. The day of starting antitumor treatment for each cycle was D1; D1-D5 was performed by the investigator on the patient for 2 times of acupuncture treatment, once a day; D8-D13 and D15-D20 were operated by patients or family members, and the investigator remotely assisted via video to complete the press needle treatment 4 times each, once a day, for four consecutive synergistic cycles, for a total of 24 times. The main acupuncture points are Guanyuan (Ren Mai 4), Shangyintang (EX-HN3), Taiyang (EX-HN5), Taichong (Liv-3), Zusanli (ST-36), and Xin (CO-15).
Sham Comparator: sham acupuncture	Device: Sham Comparator; Both groups have a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy); the sham acupuncture group is combined with sham acupuncture treatment. The day of starting antitumor treatment for each cycle was D1; D1-D5 was performed by the investigator on the patient for 2 times of sham acupuncture treatment, once a day; D8-D13 and D15-D20 were operated by patients or family members, and the investigator remotely assisted via video to complete the sham press needle treatment 4 times each, once a day, for four consecutive synergistic cycles, for a total of 24 times. The main acupuncture points are Guanyuan (Ren Mai 4), Shangyintang (EX-HN3), Taiyang (EX-HN5), Taichong (Liv-3), Zusanli (ST-36), and Xin (CO-15).; Other Names: sham acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate	At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival		At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred
Overall Survival		At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred.
Eastern Cooperative Oncology Group Performance Status, ECOG PS	Levels 0 to 5, the lower the level, the better the physical condition.	At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred
GAD-7	The total score range is 0-21 points, higher scores indicates worse results.	At 0,4,7,10,13 weeks,6 months from randomization
PHQ-9	The total score range is 0-27 points, higher scores indicates worse results.	At 0,4,7,10,13 weeks,6 months from randomization
Lung Cancer Symptom Scale	Each item is scored using the Visual Analog Scale (0-100mm), with higher scores indicating more severe symptom burden.	At 0,4,7,10,13 weeks,6,9 months from randomization
weight		At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred
adverse event	Collect blood routine, liver function, kidney function, thyroid function, myocardial enzyme spectrum, incidence of adverse reactions, and immune therapy related adverse reactions. Record the type, grading, correlation with treatment, start and end time of adverse reactions	At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred
Disease Control Rate		At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred
Insomnia Severity Index	The total score range is 0-28 points, higher scores indicates worse results.	At 0, 4, 7, 10, and 13 weeks and 6 and 9 months from randomization
Duration of immunotherapy		At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until immunotherapy is no longer used

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of belief in acupuncture	Participants will be asked: Do you think your lung cancer may be helped by acupuncture?	Baseline assessment (week 0)
Blinding assessment	Participants will be asked: Do you think you have received traditional acupuncture in the past 10 weeks?	Within 5 minutes after either treatment at week 10.

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: immunotherapy; lung cancer; acupuncture
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2024-195-KY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data and data dictionary will be available with the publication until six months after publication.
• IPD Sharing Time Frame: Deidentified participant data and data dictionary will be available with the publication until six months after publication.
• IPD Sharing Access Criteria: A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No