Lung CancersNCT06926140
Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer
A study testing Acupuncture in people with Lung Cancers, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancers
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- 21 Jun 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100053
Jiarong Fan, 86+88001196, fjrr1115@163.com
- Recruiting
Hunan Provincial Integrated Traditional Chinese and Western Medicine Hospital
Changsha, Hunan, 410006
Jian, 86+13469047364
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Zhu, 86+055162923102, ayfykyc@126.com
About this study
Official title: 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.
- Conditions
- Lung Cancers
- Being tested
- Acupuncture, Sham Comparator
- Keywords
- lung cancer, acupuncture, immunotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
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 ComparatorDevice
Also called sham acupuncture
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).
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Not described Receives: Device: Acupuncture |
| sham acupuncture | Sham comparator | Not described Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: 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
Measured: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred
Progression-Free Survival
Measured: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred
Overall Survival
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 0,4,7,10,13 weeks,6 months from randomization
Insomnia Severity Index
The total score range is 0-28 points, higher scores indicates worse results.
Measured: At 0, 4, 7, 10, and 13 weeks and 6 and 9 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.
Measured: At 0,4,7,10,13 weeks,6,9 months from randomization
weight
Measured: 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
Measured: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred
Duration of immunotherapy
Measured: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until immunotherapy is no longer used
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start21 Jun 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926140
- Sponsor's protocol ID
- 2024-195-KY
- Status last verified
- May 2025
- First submitted
- 31 Mar 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data and data dictionary will be available with the publication until six months after publication.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer：A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06926140
- Acronym / sponsor ID
- 2024-195-KY
- Conditions
- Lung Cancers
- Keywords
- lung cancer, acupuncture, immunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 21 Jun 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: Acupuncture |
| sham acupuncture | Sham comparator | Device: Sham Comparator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureBoth 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). | Device | Acupuncture |
| Sham ComparatorAlso: sham acupunctureBoth 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). | Device | sham acupuncture |
Primary outcome
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
11 secondary outcomes
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
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
Overall Survival
Time frame: 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
Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred
GAD-7
Time frame: At 0,4,7,10,13 weeks,6 months from randomization
PHQ-9
Time frame: At 0,4,7,10,13 weeks,6 months from randomization
Insomnia Severity Index
Time frame: At 0, 4, 7, 10, and 13 weeks and 6 and 9 months from randomization
Lung Cancer Symptom Scale
Time frame: At 0,4,7,10,13 weeks,6,9 months from randomization
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Yes. Deidentified participant data and data dictionary will be available with the publication until six months after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Lung Cancers, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiarong FAN (86+88001196, fjrr1115@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.