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NCT Number: NCT06926140

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

Other names: sham acupuncture

Primary outcomes

  1. Objective Response Rate

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

Secondary outcomes

  1. Disease Control Rate

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

  2. Progression-Free Survival

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

  3. Overall Survival

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

  4. Eastern Cooperative Oncology Group Performance Status, ECOG PS

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

    Levels 0 to 5, the lower the level, the better the physical condition.

  5. GAD-7

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

    The total score range is 0-21 points, higher scores indicates worse results.

  6. PHQ-9

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

    The total score range is 0-27 points, higher scores indicates worse results.

  7. Insomnia Severity Index

    Time frame: At 0, 4, 7, 10, and 13 weeks and 6 and 9 months from randomization

    The total score range is 0-28 points, higher scores indicates worse results.

  8. Lung Cancer Symptom Scale

    Time frame: At 0,4,7,10,13 weeks,6,9 months from randomization

    Each item is scored using the Visual Analog Scale (0-100mm), with higher scores indicating more severe symptom burden.

  9. weight

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

  10. adverse event

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

    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

  11. Duration of immunotherapy

    Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until immunotherapy is no longer used

Other outcomes

  1. Assessment of belief in acupuncture

    Time frame: Baseline assessment (week 0)

    Participants will be asked: Do you think your lung cancer may be helped by acupuncture?

  2. Blinding assessment

    Time frame: Within 5 minutes after either treatment at week 10.

    Participants will be asked: Do you think you have received traditional acupuncture in the past 10 weeks?

Study contacts

Contact information is provided by the study sponsor or research team.

Jiarong FAN

CONTACT

[email protected]

86+88001196

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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