Electro-Acupuncture in Lung cancER : EALER Study

NCT ID: NCT07337096

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-12-31

Brief 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 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.

Conditions

Non Small Cell Lung Cancer; Accupuncture; PD-1 Inhibitors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Acupuncture

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).

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).

Combination of chemotherapy and immunotherapy

Intervention Type: DRUG

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.

Sham acupuncture

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).

Group Type: PLACEBO_COMPARATOR

Sham acupuncture

Intervention Type: OTHER

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 immunotherapy

Intervention Type: DRUG

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.

Interventions

Acupuncture

Acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).

Intervention Type: OTHER

Sham 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).

Intervention Type: OTHER

Combination of chemotherapy and immunotherapy

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.

Intervention Type: DRUG

Other Intervention Names

Electro acupuncture; Acupuncture therapy; Placebo acupuncture

Eligibility Criteria

Inclusion Criteria

1. Pathologically confirmed NSCLC, with AJCC lung cancer TNM stage IV.

2. Tumor proportion score for PD-L1 < 50%.

3. Lacks targetable gene mutations (including but not limited to EGFR mutations or ALK fusions).

4. 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.

5. ECOG performance status score of 0-2.

6. Age ≥ 18 years.

7. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

8. 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).

9. Voluntary participation in the study, signed informed consent form, good compliance, and cooperation with follow-up.

Exclusion Criteria

1. Inability to complete baseline assessments.

2. Pregnant or lactating women, and those with psychiatric, intellectual, or language disorders.

3. Patients with autoimmune diseases or hematologic disorders requiring long-term use of hormones or immunosuppressants.

4. Presence of concurrent primary malignant tumors at other sites.

5. Participation in another investigational drug or device clinical trial within 30 days prior to the planned initiation of study treatment.

6. 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).

7. 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.

8. Active skin infection, ulceration, or lesion at acupuncture point sites that would preclude safe administration of treatment.

9. Implanted cardiac pacemaker or other active implantable electronic medical device.

10. Severe needle phobia that would prevent acceptance of needling procedures required by the study protocol.

11. Receipt of any acupuncture or related needle-based therapy within 6 weeks prior to enrollment.

12. Active pneumonitis, or radiation pneumonitis requiring treatment with systemic corticosteroids.

13. 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.

14. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haibo Zhang

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Jiangsu Provincial Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Yanjuan Zhu, MD

Role: CONTACT

zyjsophy@gzucm.edu.cn

86 20 81887233

Xiwu Rao, MD

Role: CONTACT

18851823395@163.com

86 20 81887233

Facility Contacts

Yanjuan Zhu, Dr

Role: primary

zyjsophy@gzucm.edu.cn

86 20 81887233

Xiwu Rao, Dr

Role: backup

18851823395@163.com

86 20 81887233

Hanrui Chen

Role: primary

chenhanrui1689@gzucm.edu.cn

85 20 36591912

Peng Shu

Role: primary

shupengsp@163.com

86 25 86617141

Other Identifiers

BF2025-340

Identifier Type: -

Identifier Source: org_study_id