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

NCT06926140 | Recruiting

• 1 other identifier: 2024-195-KY
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Lung Cancers

Keywords

lung cancer; acupuncture; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred

Secondary Outcomes (11)

• Disease Control Rate

  At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred

• 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

  At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred

• GAD-7

  At 0,4,7,10,13 weeks,6 months from randomization

Other Outcomes (2)

• Assessment of belief in acupuncture

  Baseline assessment (week 0)

• Blinding assessment

  Within 5 minutes after either treatment at week 10.

Study Arms (2)

Acupuncture

EXPERIMENTAL

Device: Acupuncture

sham acupuncture

SHAM COMPARATOR

Device: Sham Comparator

Interventions

Acupuncture DEVICE

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).

Acupuncture

Sham Comparator DEVICE

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).

Also known as: sham acupuncture

sham acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine

Beijing, Beijing Municipality, 100053, China

RECRUITING

Hunan Provincial Integrated Traditional Chinese and Western Medicine Hospital

Changsha, Hunan, 410006, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Jiarong FAN

CONTACT

86+88001196; fjrr1115@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professer，Chief Physician

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 13, 2025
• Study Start: June 21, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Deidentified participant data and data dictionary will be available with the publication until six months after publication.
• Access Criteria: A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.

Locations

CN (3)