RecruitingNot ApplicableNCT06926140

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

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Enrollment

240 participants

Start Date

Jun 21, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancers

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding acupuncture alongside immunotherapy (PD-1/PD-L1 checkpoint inhibitors) and chemotherapy can improve outcomes for patients with advanced lung cancer. The focus is particularly on patients whose tumours have low levels of PD-L1 (a marker used to predict immunotherapy response). **You may be eligible if...** - You are between 18 and 75 years old with good performance status - You have advanced non-small cell lung cancer (stage IIIB–IV) or extensive-stage small cell lung cancer - Your tumour's PD-L1 score is below 50% - You have not received any prior systemic treatment for your cancer - Your traditional Chinese medicine assessment identifies a "Qi Depression" pattern - You have at least one measurable tumour on scans **You may NOT be eligible if...** - You have certain gene mutations (e.g., EGFR, ALK, ROS1, BRAF) with approved targeted therapies available - You have previously had systemic cancer treatment - You are not suitable for combined chemotherapy and immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAcupuncture

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).

DEVICESham 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).

Locations(3)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine

Beijing, Beijing Municipality, China

Hunan Provincial Integrated Traditional Chinese and Western Medicine Hospital

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06926140

Related Trials

Identification and Validation of Blood-Based Biomarkers for Early Detection of Asymptomatic Lung Cancer in High-Risk Heavy Smokers

NCT068161211 location

Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery

NCT068103751 location