Non-Small Cell Lung CancerNCT07239661
Electroacupuncture Combined With PD-1 Inhibitor for ECOG2 Advanced NSCLC
A study testing Electroacupuncture (EA) in people with Non-Small Cell Lung Cancer and Electroacupuncture, run by Kong Fanming at 1 site in China.
Trial summary
The aim of this study was to systematically evaluate the clinical efficacy and safety of electroacupuncture (EA) combined with PD-1 inhibitors in patients with advanced non-small cell lung cancer (NSCLC) who have an ECOG performance status of 2 through a multicenter, randomized, sham-controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Electroacupuncture, PD-1 Inhibitors
- What is being tested?
- Electroacupuncture (EA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 31 Dec 2027
- 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
- Patients diagnosed with stage ⅢB-Ⅳ non-small cell lung cancer (NSCLC) confirmed by pathological or cytological examination;
- Patients with negative driver gene mutations, excluding those harboring EGFR mutations, ALK rearrangements, or other common driver gene alterations as determined by genetic testing or other molecular biological methods;
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 2;
- A programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥ 1%;
- An expected survival time of more than 3 months, as assessed by the clinician based on the patient's overall condition, tumor progression, and response to treatment;
- Patients with good treatment compliance who provided written informed consent, confirming their understanding of and willingness to undergo treatment and follow-up according to the study protocol.
Who cannot join
- Patients with a history or concurrent diagnosis of other malignant tumors within the past five years;
- Patients with severe organ impairment or serious comorbidities, such as cardiac dysfunction (New York Heart Association [NYHA] class Ⅲ-Ⅳ), hepatic or renal insufficiency, as determined by standard clinical examinations including liver and kidney function tests and electrocardiography;
- Patients with untreated central nervous system (CNS) metastases were excluded; eligible patients were required to have stable disease confirmed by imaging after receiving at least one systemic or surgical treatment;
- Patients with psychiatric disorders, including schizophrenia or bipolar disorder, particularly those requiring pharmacologic treatment;
- Patients with a history of multiple drug allergies, an allergic predisposition, or a history of severe allergic reactions such as anaphylactic shock or allergic rash;
- Subjects with active autoimmune or infectious diseases, including but not limited to chronic viral hepatitis, active pulmonary tuberculosis, or other infections or autoimmune disorders deemed by clinicians to potentially affect the study;
- Female patients who were pregnant or lactating.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
Fanming Kong, PhD, +86 22 27986525, kongfanming08@163.com
About this study
Official title: The Clinical Efficacy of Electroacupuncture Combined With PD-1 Inhibitor in the Treatment of ECOG2 Advanced Non-small Cell Lung Cancer
The aim of this study was to systematically evaluate the clinical efficacy and safety of electroacupuncture (EA) combined with PD-1 inhibitors in patients with advanced non-small cell lung cancer (NSCLC) who have an ECOG performance status of 2 through a multicenter, randomized, sham-controlled clinical trial. The core scientific question addressed in this study was whether EA combined with standard immunotherapy could further improve progression-free survival (PFS), immune function, and quality of life in these patients. Patients meeting the inclusion criteria were randomly assigned in a 1:1 ratio to receive EA plus a PD-1 inhibitor (trial group) or sham EA plus a PD-1 inhibitor (control group) through a computerized randomization system. PD-1 inhibitors were administered every 21 days for four to six cycles, followed by maintenance therapy according to each patient's condition. EA intervention was initiated on the first day of each immunotherapy cycle and administered once daily for five sessions per cycle, continuing for four to six cycles. The primary endpoint was progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), overall survival (OS), first-line treatment completion rate, quality of life as assessed by the EORTC QLQ-C30 scale, traditional Chinese medicine (TCM) syndrome score, immune function index, and incidence of adverse events according to CTCAE 5.0 criteria. In addition, peripheral blood was collected from patients at baseline for non-coding RNA sequencing, and differentially expressed genes were identified through bioinformatics analysis to determine potential molecular biomarkers associated with the synergistic effects of EA, thereby providing a basis for accurately identifying patients likely to benefit from EA therapy.
Read the detailed description
Based on the principles of evidence-based medicine, a randomized controlled clinical trial was conducted to provide high-quality evidence on the clinical efficacy and immunomodulatory effects of acupuncture combined with first-line immunotherapy in patients with advanced NSCLC with an ECOG PS2, thereby facilitating the promotion and application of "precision" traditional Chinese medicine (TCM) treatment. This project provides an evidence-based reference for developing standardized treatment protocols and clinical pathways for advanced NSCLC and further clarifies the potential role of TCM within the therapeutic framework of advanced lung cancer, holding significant academic value and substantial social benefits.
- Being tested
- Electroacupuncture (EA), Sham electroacupuncture
- Keywords
- electroacupuncture, Immunotherapy, immune checkpoint inhibitor, Non-Small Cell Lung Cancer, ECOG PS 2 points
- 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.
Electroacupuncture (EA)Other
In the electroacupuncture group, bilateral Zusanli (ST36) and Sanyinjiao (SP6) points were selected for needling. Upon achieving the "deqi" sensation, the electroacupuncture device was connected to the needles at both points. A dispersed-dense wave was applied with an intensity ranging from 0.5 to 2 mA, adjusted according to the patient's tolerance. The needles were retained for 20 minutes, after which they were removed.
Sham electroacupunctureOther
In the sham electroacupuncture group, bilateral Zusanli (ST36) and Sanyinjiao (SP6) points were selected for sham electroacupuncture intervention, which did not receive manual manipulation. The electrode placement and other treatment settings were identical to those in the electroacupuncture group, but no skin penetration, electrical output, or needle techniques were applied to induce the sensation of "deqi." No genuine electroacupuncture stimulation was administered in this group.
| Study group | Role | What they receive |
|---|---|---|
| EA + ICIs group | Experimental | Bilateral Zusanli (ST36) and Sanyinjiao (SP6) acupoints were selected. After obtaining deqi sensation upon needle insertion, an electroacupuncture device was connected to each of the selected acupoints. A sparse-dense wave mode was chosen, with an intensity ranging from 0.5 to 2 mA, adjusted according to patient tolerance. The needles were retained for 20 minutes before removal. The electroacupuncture treatment was initiated on the same day as the commencement of the immunotherapy cycle, administered once daily for a total of five sessions, ensuring that each immunotherapy cycle was synchronized with electroacupuncture treatment. The overall treatment consisted of 4 to 6 cycles. Receives: Other: Electroacupuncture (EA) |
| Sham EA + ICIs group | Sham comparator | Bilateral Zusanli (ST36) and Sanyinjiao (SP6) acupoints were selected. Electroacupuncture devices were connected to these acupoints. A sparse-dense wave mode was utilized, with an intensity ranging from 0.5 to 2 mA, and the needles were retained for 20 minutes before removal. In the sham electroacupuncture group, no manual manipulation was performed. The placement of electrodes and other treatment settings were identical to those in the electroacupuncture group, but without skin penetration, electrical output, or needling techniques to induce deqi. Electroacupuncture treatment was initiated on the same day as the start of the immunotherapy cycle, administered once daily for a total of five sessions, ensuring synchronization with each immunotherapy cycle. The overall treatment regimen consisted of 4 to 6 cycles. Receives: Other: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Defined as the interval from the time of enrollment to the first documentation of disease progression or death from any cause.
Measured: Defined as the time interval from the date of enrollment to the first documented occurrence of disease progression or death from any cause, whichever comes first. This outcome will be assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kong Fanming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kong Fanming, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239661
- Sponsor's protocol ID
- TYLL2025[K]016
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This decision may stem from concerns regarding privacy or ethical issues associated with data sharing, or because the research data is considered proprietary and not intended for public disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Electroacupuncture Combined With PD-1 Inhibitor in the Treatment of ECOG2 Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07239661
- Acronym / sponsor ID
- TYLL2025[K]016
- Keywords
- electroacupuncture, Immunotherapy, immune checkpoint inhibitor, Non-Small Cell Lung Cancer, ECOG PS 2 points
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kong FanmingUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Nov 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.
The aim of this study was to systematically evaluate the clinical efficacy and safety of electroacupuncture (EA) combined with PD-1 inhibitors in patients with advanced non-small cell lung cancer (NSCLC) who have an ECOG performance status of 2 through a multicenter, randomized, sham-controlled clinical trial. The core scientific question addressed in this study was whether EA combined with standard immunotherapy could further improve progression-free survival (PFS), immune function, and quality of life in these patients. Patients meeting the inclusion criteria were randomly assigned in a 1:1 ratio to receive EA plus a PD-1 inhibitor (trial group) or sham EA plus a PD-1 inhibitor (control group) through a computerized randomization system. PD-1 inhibitors were administered every 21 days for four to six cycles, followed by maintenance therapy according to each patient's condition. EA intervention was initiated on the first day of each immunotherapy cycle and administered once daily for five sessions per cycle, continuing for four to six cycles. The primary endpoint was progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), overall survival (OS), first-line treatment completion rate, quality of life as assessed by the EORTC QLQ-C30 scale, traditional Chinese medicine (TCM) syndrome score, immune function index, and incidence of adverse events according to CTCAE 5.0 criteria. In addition, peripheral blood was collected from patients at baseline for non-coding RNA sequencing, and differentially expressed genes were identified through bioinformatics analysis to determine potential molecular biomarkers associated with the synergistic effects of EA, thereby providing a basis for accurately identifying patients likely to benefit from EA therapy.
Detailed description
Based on the principles of evidence-based medicine, a randomized controlled clinical trial was conducted to provide high-quality evidence on the clinical efficacy and immunomodulatory effects of acupuncture combined with first-line immunotherapy in patients with advanced NSCLC with an ECOG PS2, thereby facilitating the promotion and application of "precision" traditional Chinese medicine (TCM) treatment. This project provides an evidence-based reference for developing standardized treatment protocols and clinical pathways for advanced NSCLC and further clarifies the potential role of TCM within the therapeutic framework of advanced lung cancer, holding significant academic value and substantial social benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA + ICIs group | Experimental | Other: Electroacupuncture (EA)Bilateral Zusanli (ST36) and Sanyinjiao (SP6) acupoints were selected. After obtaining deqi sensation upon needle insertion, an electroacupuncture device was connected to each of the selected acupoints. A sparse-dense wave mode was chosen, with an intensity ranging from 0.5 to 2 mA, adjusted according to patient tolerance. The needles were retained for 20 minutes before removal. The electroacupuncture treatment was initiated on the same day as the commencement of the immunotherapy cycle, administered once daily for a total of five sessions, ensuring that each immunotherapy cycle was synchronized with electroacupuncture treatment. The overall treatment consisted of 4 to 6 cycles. |
| Sham EA + ICIs group | Sham comparator | Other: Sham electroacupunctureBilateral Zusanli (ST36) and Sanyinjiao (SP6) acupoints were selected. Electroacupuncture devices were connected to these acupoints. A sparse-dense wave mode was utilized, with an intensity ranging from 0.5 to 2 mA, and the needles were retained for 20 minutes before removal. In the sham electroacupuncture group, no manual manipulation was performed. The placement of electrodes and other treatment settings were identical to those in the electroacupuncture group, but without skin penetration, electrical output, or needling techniques to induce deqi. Electroacupuncture treatment was initiated on the same day as the start of the immunotherapy cycle, administered once daily for a total of five sessions, ensuring synchronization with each immunotherapy cycle. The overall treatment regimen consisted of 4 to 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with stage ⅢB-Ⅳ non-small cell lung cancer (NSCLC) confirmed by pathological or cytological examination;
- Patients with negative driver gene mutations, excluding those harboring EGFR mutations, ALK rearrangements, or other common driver gene alterations as determined by genetic testing or other molecular biological methods;
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 2;
- A programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥ 1%;
- An expected survival time of more than 3 months, as assessed by the clinician based on the patient's overall condition, tumor progression, and response to treatment;
Key exclusion criteria (7 listed)
- Patients with a history or concurrent diagnosis of other malignant tumors within the past five years;
- Patients with severe organ impairment or serious comorbidities, such as cardiac dysfunction (New York Heart Association [NYHA] class Ⅲ-Ⅳ), hepatic or renal insufficiency, as determined by standard clinical examinations including liver and kidney function tests and electrocardiography;
- Patients with untreated central nervous system (CNS) metastases were excluded; eligible patients were required to have stable disease confirmed by imaging after receiving at least one systemic or surgical treatment;
- Patients with psychiatric disorders, including schizophrenia or bipolar disorder, particularly those requiring pharmacologic treatment;
- Patients with a history of multiple drug allergies, an allergic predisposition, or a history of severe allergic reactions such as anaphylactic shock or allergic rash;
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 |
|---|---|---|
| Electroacupuncture (EA)In the electroacupuncture group, bilateral Zusanli (ST36) and Sanyinjiao (SP6) points were selected for needling. Upon achieving the "deqi" sensation, the electroacupuncture device was connected to the needles at both points. A dispersed-dense wave was applied with an intensity ranging from 0.5 to 2 mA, adjusted according to the patient's tolerance. The needles were retained for 20 minutes, after which they were removed. | Other | EA + ICIs group |
| Sham electroacupunctureIn the sham electroacupuncture group, bilateral Zusanli (ST36) and Sanyinjiao (SP6) points were selected for sham electroacupuncture intervention, which did not receive manual manipulation. The electrode placement and other treatment settings were identical to those in the electroacupuncture group, but no skin penetration, electrical output, or needle techniques were applied to induce the sensation of "deqi." No genuine electroacupuncture stimulation was administered in this group. | Other | Sham EA + ICIs group |
Primary outcome
progression-free survival
Time frame: Defined as the time interval from the date of enrollment to the first documented occurrence of disease progression or death from any cause, whichever comes first. This outcome will be assessed up to 100 months.
Defined as the interval from the time of enrollment to the first documentation of disease progression or death from any cause.
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 20 Nov 2025.
- Individual participant dataSharing planned: No. This decision may stem from concerns regarding privacy or ethical issues associated with data sharing, or because the research data is considered proprietary and not intended for public disclosure.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture (EA) in people with Non-Small Cell Lung Cancer and Electroacupuncture, run by Kong Fanming at 1 site 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 6 inclusion and 7 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Fanming Kong, PhD (+86 22 27986525, kongfanming08@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: Defined as the time interval from the date of enrollment to the first documented occurrence of disease progression or death from any cause, whichever comes first. This outcome will be assessed up to 100 months.). 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 20 Nov 2025.