Non-small Cell Lung CancerNCT06461338
Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study
A study testing acupuncture in people with Non-small Cell Lung Cancer and Non-Small-Cell Lung Carcinoma, run by Guangzhou University of Traditional Chinese Medicine at 3 sites in China.
Trial summary
This multicentre, randomized controlled trial evaluates the effect and safety of integrating acupuncture with immunotherapeutic sensitization in treating NSCLC. Participants will be randomly assigned to undergo either acupuncture or sham acupuncture concurrent with the initial four cycles of standard ICIs combined… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesChina
- Study dates
- 15 Aug 2024to Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a histologically-confirmed or cytologically confirmed diagnosis of stage IIIB or IV NSCLC.
- PD-L1 TPS<50%
- EGFR/ALK wild-type
- Has not received prior systemic treatment for advanced NSCLC. For patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. Patients who received targeted therapy or immunotherapy can not be enrolled.
- Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Age≥18 years
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- Has a life expectancy of at least 3 months
- Has measurable disease
- Has adequate organ function
- Voluntarily enrolled into the study, sign the informed consent form and have good compliance
Who cannot join
- Unable to complete baseline assessments
- Expected to receive radiotherapy within the next 4 cycles
- With a combination of serious primary diseases of the heart, cerebrovascular, hepatic, renal, and hematopoietic systems
- With dementia, neurological disorders, mental retardation, or language impairment, and pregnant or breastfeeding women
- Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs
- Combined with a primary tumor from other sites
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- Had participated in any other clinical trial within the prior 3 months
- Has known history of Human Immunodeficiency Virus (HIV) or solid organ transplantation
- With legal incapacity
- With skin breakdown at the acupuncture point that interferes with treatment
- With a pacemaker
- With a fear of acupuncture
- Had received acupuncture treatment within 6 weeks
- Has known active Hepatitis B
- Has interstitial lung disease or a history of pneumonitis that required oral of IV glucocorticoids to assist with management
- Has fever (>38°C) or clinically significant infection within 1 week prior to enrolment
- Has active tuberculosis or indications of severe or uncontrolled systemic diseases
- With a bleeding tendency, and receiving thrombolytics or anticoagulants
Trial locations and contacts
3 sites in 1 country.
China3 sites
The First Affiliated Hospital of Guangzhou University of Chinese Medicine.
Guangzhou, Guangdong, 510000
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Jiangsu Provincial Hospital of Chinese Medicine
Nanjing, Jiangsu, 210000
About this study
Official title: Acupuncture for Enhancing the Effect of Immunotherapy in Advanced NSCLC: a Pilot Study
This multicentre, randomized controlled trial evaluates the effect and safety of integrating acupuncture with immunotherapeutic sensitization in treating NSCLC. Participants will be randomly assigned to undergo either acupuncture or sham acupuncture concurrent with the initial four cycles of standard ICIs combined with chemotherapy.
- Being tested
- acupuncture, Sham acupuncture
- Keywords
- Non-Small Cell Lung Cancer, Acupuncture, Immune Checkpoint Inhibitors, Effect, Safety
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).
Sham acupunctureProcedure or surgery
Sham acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with sham electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture for 4 times every 3 weeks (one cycle of ICIs combined with chemotherapy) for 12 weeks (4 cycles of ICIs combined with chemotherapy) Receives: Procedure: acupuncture |
| Sham acupuncture | Sham comparator | Sham acupuncture for 4 times every 3 weeks (one cycle of ICIs combined with chemotherapy) for 12 weeks (4 cycles of ICIs combined with chemotherapy) Receives: Procedure: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progress free survival defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Secondary outcomes (6)
Overall survival
Overall survival is defined as the time until death due to any cause
Measured: From date of randomization until the date of death from any cause, assessed up to 5 years.
Objective response rate
Objective response rate is defined as the proportion of patients achieving complete (iCR/CR) or partial (iPR/PR) response according to iRECIST or RECIST V.1.1 criteria
Measured: Through study completion, an average of 3 years.
Disease control rate
Disease control rate is determined by the percentage of patients who achieve CR, PR, or SD as defined by iRECIST or RECIST V.1.1 criteria. This encompasses all instances of CR, PR, and SD (CR + PR + SD).
Measured: Through study completion, an average of 3 years.
Duration of response
Duration of response is assessed only in patients achieving CR, PR, or nPR and was defined as the time from first assessment showing CR, PR, or nPR to earliest date of either PD or death.
Measured: Through study completion, an average of 3 years.
Quality of life evaluation
According to the requirements of European Organisation for Research and Treatment of Cancer-quality of life core questionnaire (EORTC QLQ-C30)/Lung cancer 13 items (LC13), the scoring results of each field of the scale were recorded in CRF. The score of this questionnaire ranges between 1 and 4. The higher score indicates the worse quality of life.
Measured: At the baseline, day 8 of Cycle 1-4 (each cycle is 21 days), and day 1 of Cycle 5 (each cycle is 21 days), up to approximately 6 months.
Symptom evaluation
According to the requirements of Lung cancer symptom scale (LCSS), the scoring results of each field of the scale were recorded in CRF. The score of this questionnaire ranges between 0 and 10. The higher score indicates the worse symptom.
Measured: At the baseline, day 8 of Cycle 1-4 (each cycle is 21 days), and day 1 of Cycle 5 (each cycle is 21 days), up to approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start15 Aug 2024
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Jiangsu Province Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Haibo Zhang, M.D., Principal investigator, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461338
- Sponsor's protocol ID
- 2023YFC3503303
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Enhancing the Effect of Immunotherapy in Advanced NSCLC: a Pilot Study
- ClinicalTrials.gov ID
- NCT06461338
- Acronym / sponsor ID
- 2023YFC3503303
- Keywords
- Non-Small Cell Lung Cancer, Acupuncture, Immune Checkpoint Inhibitors, Effect, Safety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Jiangsu Province Hospital of Traditional Chinese Medicine
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Jun 2024 (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 multicentre, randomized controlled trial evaluates the effect and safety of integrating acupuncture with immunotherapeutic sensitization in treating NSCLC. Participants will be randomly assigned to undergo either acupuncture or sham acupuncture concurrent with the initial four cycles of standard ICIs combined with chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: acupunctureAcupuncture for 4 times every 3 weeks (one cycle of ICIs combined with chemotherapy) for 12 weeks (4 cycles of ICIs combined with chemotherapy) |
| Sham acupuncture | Sham comparator | Procedure: Sham acupunctureSham acupuncture for 4 times every 3 weeks (one cycle of ICIs combined with chemotherapy) for 12 weeks (4 cycles of ICIs combined with chemotherapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has a histologically-confirmed or cytologically confirmed diagnosis of stage IIIB or IV NSCLC.
- PD-L1 TPS<50%
- EGFR/ALK wild-type
- Has not received prior systemic treatment for advanced NSCLC. For patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. Patients who received targeted therapy or immunotherapy can not be enrolled.
- Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
Key exclusion criteria (18 listed)
- Unable to complete baseline assessments
- Expected to receive radiotherapy within the next 4 cycles
- With a combination of serious primary diseases of the heart, cerebrovascular, hepatic, renal, and hematopoietic systems
- With dementia, neurological disorders, mental retardation, or language impairment, and pregnant or breastfeeding women
- Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs
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 |
|---|---|---|
| acupunctureAcupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6). | Procedure or surgery | Acupuncture |
| Sham acupunctureSham acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with sham electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6). | Procedure or surgery | Sham acupuncture |
Primary outcome
Progression free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Progress free survival defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause
6 secondary outcomes
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years.
Objective response rate
Time frame: Through study completion, an average of 3 years.
Disease control rate
Time frame: Through study completion, an average of 3 years.
Duration of response
Time frame: Through study completion, an average of 3 years.
Quality of life evaluation
Time frame: At the baseline, day 8 of Cycle 1-4 (each cycle is 21 days), and day 1 of Cycle 5 (each cycle is 21 days), up to approximately 6 months.
Symptom evaluation
Time frame: At the baseline, day 8 of Cycle 1-4 (each cycle is 21 days), and day 1 of Cycle 5 (each cycle is 21 days), up to approximately 6 months.
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 17 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Haibo Zhang, M.D. principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
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 Non-small Cell Lung Cancer and Non-Small-Cell Lung Carcinoma, run by Guangzhou University of Traditional Chinese Medicine 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 18 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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.). 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 17 Dec 2025.