Non Small Cell Lung CancerNCT07337096
Electro-Acupuncture in Lung cancER : EALER Study
A study testing Acupuncture and Combination of chemotherapy and immunotherapy in people with Non Small Cell Lung Cancer and Accupuncture, 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 acupuncture combing with PD-1 inhibitors plus chemotherapy in NSCLC. Participants will be randomly assigned to undergo either acupuncture or sham acupuncture concurrent with the initial four-six cycles of chemotherapy combined with PD-1… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Accupuncture, PD-1 Inhibitors
- What is being tested?
- Acupuncture and Combination of chemotherapy and immunotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 3 sitesChina
- Study dates
- 15 Jan 2026to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed NSCLC, with AJCC lung cancer TNM stage IV.
- Tumor proportion score for PD-L1 < 50%.
- Lacks targetable gene mutations (including but not limited to EGFR mutations or ALK fusions).
- No prior systemic therapy for advanced NSCLC (including chemotherapy, targeted therapy, or immunotherapy). Patients planned to receive first-line (induction) treatment with ICIs plus chemotherapy are eligible. Patients who have received prior neoadjuvant or adjuvant therapy, or definitive chemoradiotherapy, may be enrolled if provided that disease progression occurred more than 6 months after the completion of the last treatment.
- ECOG performance status score of 0-2.
- Age ≥ 18 years.
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- At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate organ function (hematology: ANC ≥ 1500/mcL, PLT ≥ 100,000/mcL, Hb ≥ 9.0 g/dL or ≥ 5.6 mmol/L; renal function: estimated creatinine clearance ≥ 50 mL/min; hepatic function: serum total bilirubin ≤ 1.5 × ULN or total bilirubin > 1.5 × ULN with direct bilirubin ≤ ULN, AST and ALT ≤ 2.5 × ULN ≤ 5 × ULN for patients with liver metastases).
- Voluntary participation in the study, signed informed consent form, good compliance, and cooperation with follow-up.
Who cannot join
- Inability to complete baseline assessments.
- Pregnant or lactating women, and those with psychiatric, intellectual, or language disorders.
- Patients with autoimmune diseases or hematologic disorders requiring long-term use of hormones or immunosuppressants.
- Presence of concurrent primary malignant tumors at other sites.
- Participation in another investigational drug or device clinical trial within 30 days prior to the planned initiation of study treatment.
- Known seropositivity for human immunodeficiency virus (HIV), other congenital or acquired immunodeficiencies, or history of organ or stem cell transplantation (including autologous bone marrow or peripheral blood stem cell transplantation).
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- Loss of self-care capacity, or any medical, psychological, or ethical condition that, in the investigator's judgment, could interfere with the patient's ability to complete the study.
- Active skin infection, ulceration, or lesion at acupuncture point sites that would preclude safe administration of treatment.
- Implanted cardiac pacemaker or other active implantable electronic medical device.
- Severe needle phobia that would prevent acceptance of needling procedures required by the study protocol.
- Receipt of any acupuncture or related needle-based therapy within 6 weeks prior to enrollment.
- Active pneumonitis, or radiation pneumonitis requiring treatment with systemic corticosteroids.
- Active infection requiring antimicrobial therapy (antibacterial, antifungal, or antiviral agents) according to clinical guidelines at the time of screening. Enrollment may be reconsidered after the infection has been adequately controlled.
- Active tuberculosis infection, or any severe or uncontrolled systemic illness, including but not limited to clinically significant neurological conditions (e.g., uncontrolled seizures, dementia), unstable or decompensated respiratory, cardiac, hepatic, or renal disease.
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
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 34830
Yanjuan Zhu, Dr, 86 20 81887233, zyjsophy@gzucm.edu.cn
Xiwu Rao, Dr, 86 20 81887233, 18851823395@163.com
- Recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510000
Hanrui Chen, 85 20 36591912, chenhanrui1689@gzucm.edu.cn
- Recruiting
Jiangsu Provincial Hospital of Chinese Medicine
Nanjing, Jiangsu, 210000
Peng Shu, 86 25 86617141, shupengsp@163.com
About this study
Official title: Electro-acupuncture Plus PD-1 Inhibitors and Chemotherapy as First-Line Treatment for Metastatic Non-Small Cell Lung Cancer: A Randomized Trial
This multicentre, randomized controlled trial evaluates the effect and safety of acupuncture combing with PD-1 inhibitors plus chemotherapy in NSCLC. Participants will be randomly assigned to undergo either acupuncture or sham acupuncture concurrent with the initial four-six cycles of chemotherapy combined with PD-1 inhibitors.
Read the detailed description
This multicenter, randomized controlled clinical trial designed to evaluate the efficacy and safety of electro-acupuncture (EA) as an adjunctive therapy, combined with PD-1 inhibitors and chemotherapy, as a first-line treatment for advanced NSCLC. This trial plans to enroll 424 patients with advanced NSCLC who are negative for actionable driver gene mutations, including but not limited to EGFR and ALK, and a PD-L1 tumor proportion score (TPS) below 50%. Through a central randomization system, participants will be allocated in a 1:1 ratio to either the EA group or the sham-acupuncture control group. The intervention will be administered concurrently with the induction-phase chemotherapy combined with PD-1 inhibitor therapy, for a total of 4 to 6 cycles.
The primary endpoint is progression-free survival (PFS), defined as the time from randomization to the first documented disease progression or death. Secondary efficacy endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), and duration of response (DoR). The symptom burden and health-related quality of life, will be assessed using the Lung Cancer Symptom Scale (LCSS) and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) with its lung cancer-specific module (QLQ-LC13). Safety and tolerability will be evaluated based on the incidence, severity, and causality of adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE). Immune-related adverse events (irAEs) will be specifically managed per the NCCN Guidelines for Management of Immunotherapy-Related Toxicities. Efficacy analyses will be performed on the full analysis set (FAS) following the intention-to-treat (ITT) principle. Sensitivity analyses will be conducted on the per-protocol set (PPS) to assess the robustness of the primary findings.
- Conditions
- Non Small Cell Lung Cancer, Accupuncture, PD-1 Inhibitors
- Being tested
- Acupuncture, Sham acupuncture, Combination of chemotherapy and immunotherapy
- 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.
AcupunctureOther
Also called Electro acupuncture, Acupuncture therapy
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 acupunctureOther
Also called Placebo acupuncture
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).
Combination of chemotherapy and immunotherapyDrug
For patients with non-squamous cell carcinoma: PD-1 inhibitor plus AP regimen chemotherapy (Pemetrexed + Carboplatin or Cisplatin, every 3 weeks) for 4-6 cycles.
For patients with squamous cell carcinoma: PD-1 inhibitor plus TP or GP regimen chemotherapy (Paclitaxel or Liposomal Paclitaxel + Carboplatin or Cisplatin , nab-paclitaxel + Carboplatin or Cisplatin, Gemcitabine + Carboplatin or Cisplatin, every 3 weeks) for 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Participants will receive 4 times of electro-acupuncture per cycle during the 4-6 cycle of induction chemotherapy combined with PD-1 inhibitors (16-24 sessions of electro-acupuncture in total). Receives: Other: Acupuncture; Drug: Combination of chemotherapy and immunotherapy |
| Sham acupuncture | Placebo comparator | Participants will receive 4 times of sham acupuncture per cycle during the 4-6 cycle of induction chemotherapy combined with PD-1 inhibitors (16-24 sessions of sham acupuncture in total). Receives: Other: Sham acupuncture; Drug: Combination of chemotherapy and immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of either objective disease progression or death from 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 from the date of randomization 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 (ORR) is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) 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 (DoR) is defined, for patients with a confirmed objective response (CR or PR), as the time from the date of the first documented response until the date of first documented disease progression or death from any cause.
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 baseline, on Day 8 of each induction chemotherapy cycle (up to 6 cycles, each cycle is 21 days), and on Day 1 of the first maintenance therapy cycle following completion of the induction phase.
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 baseline, on Day 8 of each induction chemotherapy cycle (up to 6 cycles, each cycle is 21 days), and on Day 1 of the first maintenance therapy cycle following completion of the induction phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start15 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (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
- 424 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, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337096
- Sponsor's protocol ID
- BF2025-340
- Status last verified
- Jun 2026
- First submitted
- 9 Dec 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon study completion and primary results publication, de-identified individual participant data (IPD) that underlie the reported findings may be made available to qualified researchers upon reasonable request. Any data sharing will be contingent on approval of a detailed research proposal and a signed data access agreement, which will include commitments to using the data only for the approved purpose, to securing the data appropriately, and to destroying or returning the data after analysis completion.Researchers interested in accessing the data should contact the corresponding author or the study sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro-acupuncture Plus PD-1 Inhibitors and Chemotherapy as First-Line Treatment for Metastatic Non-Small Cell Lung Cancer: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07337096
- Acronym / sponsor ID
- BF2025-340
- Conditions
- Non Small Cell Lung Cancer, Accupuncture, PD-1 Inhibitors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 424 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 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Jan 2026 (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 acupuncture combing with PD-1 inhibitors plus chemotherapy in NSCLC. Participants will be randomly assigned to undergo either acupuncture or sham acupuncture concurrent with the initial four-six cycles of chemotherapy combined with PD-1 inhibitors.
Detailed description
This multicenter, randomized controlled clinical trial designed to evaluate the efficacy and safety of electro-acupuncture (EA) as an adjunctive therapy, combined with PD-1 inhibitors and chemotherapy, as a first-line treatment for advanced NSCLC. This trial plans to enroll 424 patients with advanced NSCLC who are negative for actionable driver gene mutations, including but not limited to EGFR and ALK, and a PD-L1 tumor proportion score (TPS) below 50%. Through a central randomization system, participants will be allocated in a 1:1 ratio to either the EA group or the sham-acupuncture control group. The intervention will be administered concurrently with the induction-phase chemotherapy combined with PD-1 inhibitor therapy, for a total of 4 to 6 cycles.
The primary endpoint is progression-free survival (PFS), defined as the time from randomization to the first documented disease progression or death. Secondary efficacy endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), and duration of response (DoR). The symptom burden and health-related quality of life, will be assessed using the Lung Cancer Symptom Scale (LCSS) and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) with its lung cancer-specific module (QLQ-LC13). Safety and tolerability will be evaluated based on the incidence, severity, and causality of adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE). Immune-related adverse events (irAEs) will be specifically managed per the NCCN Guidelines for Management of Immunotherapy-Related Toxicities. Efficacy analyses will be performed on the full analysis set (FAS) following the intention-to-treat (ITT) principle. Sensitivity analyses will be conducted on the per-protocol set (PPS) to assess the robustness of the primary findings.
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 | Other: Acupuncture, Drug: Combination of chemotherapy and immunotherapyParticipants will receive 4 times of electro-acupuncture per cycle during the 4-6 cycle of induction chemotherapy combined with PD-1 inhibitors (16-24 sessions of electro-acupuncture in total). |
| Sham acupuncture | Placebo comparator | Other: Sham acupuncture, Drug: Combination of chemotherapy and immunotherapyParticipants will receive 4 times of sham acupuncture per cycle during the 4-6 cycle of induction chemotherapy combined with PD-1 inhibitors (16-24 sessions of sham acupuncture in total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologically confirmed NSCLC, with AJCC lung cancer TNM stage IV.
- Tumor proportion score for PD-L1 < 50%.
- Lacks targetable gene mutations (including but not limited to EGFR mutations or ALK fusions).
- No prior systemic therapy for advanced NSCLC (including chemotherapy, targeted therapy, or immunotherapy). Patients planned to receive first-line (induction) treatment with ICIs plus chemotherapy are eligible. Patients who have received prior neoadjuvant or adjuvant therapy, or definitive chemoradiotherapy, may be enrolled if provided that disease progression occurred more than 6 months after the completion of the last treatment.
- ECOG performance status score of 0-2.
Key exclusion criteria (14 listed)
- Inability to complete baseline assessments.
- Pregnant or lactating women, and those with psychiatric, intellectual, or language disorders.
- Patients with autoimmune diseases or hematologic disorders requiring long-term use of hormones or immunosuppressants.
- Presence of concurrent primary malignant tumors at other sites.
- Participation in another investigational drug or device clinical trial within 30 days prior to the planned initiation of study treatment.
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 |
|---|---|---|
| AcupunctureAlso: Electro acupuncture, Acupuncture therapyAcupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6). | Other | Acupuncture |
| Sham acupunctureAlso: Placebo 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). | Other | Sham acupuncture |
| Combination of chemotherapy and immunotherapyFor patients with non-squamous cell carcinoma: PD-1 inhibitor plus AP regimen chemotherapy (Pemetrexed + Carboplatin or Cisplatin, every 3 weeks) for 4-6 cycles. For patients with squamous cell carcinoma: PD-1 inhibitor plus TP or GP regimen chemotherapy (Paclitaxel or Liposomal Paclitaxel + Carboplatin or Cisplatin , nab-paclitaxel + Carboplatin or Cisplatin, Gemcitabine + Carboplatin or Cisplatin, every 3 weeks) for 4-6 cycles. | Drug | Acupuncture, 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.
Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of either objective disease progression or death from 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 baseline, on Day 8 of each induction chemotherapy cycle (up to 6 cycles, each cycle is 21 days), and on Day 1 of the first maintenance therapy cycle following completion of the induction phase.
Symptom evaluation
Time frame: At baseline, on Day 8 of each induction chemotherapy cycle (up to 6 cycles, each cycle is 21 days), and on Day 1 of the first maintenance therapy cycle following completion of the induction phase.
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 Jun 2026.
- Individual participant dataSharing planned: No. Upon study completion and primary results publication, de-identified individual participant data (IPD) that underlie the reported findings may be made available to qualified researchers upon reasonable request. Any data sharing will be contingent on approval of a detailed research proposal and a signed data access agreement, which will include commitments to using the data only for the approved purpose, to securing the data appropriately, and to destroying or returning the data after analysis completion.Researchers interested in accessing the data should contact the corresponding author or the study sponsor.
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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.
Haibo Zhang 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 and Combination of chemotherapy and immunotherapy in people with Non Small Cell Lung Cancer and Accupuncture, 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 9 inclusion and 14 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 Jun 2026. 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 Yanjuan Zhu, MD (86 20 81887233, zyjsophy@gzucm.edu.cn), 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: 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 24 Jun 2026.