Electro-Acupuncture in Lung cancER : EALER Study

NCT07337096 | Recruiting

• 1 other identifier: BF2025-340
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From date of randomization until the date of death from any cause, assessed up to 5 years.

• Objective response rate

  Through study completion, an average of 3 years.

• Disease control rate

  Through study completion, an average of 3 years.

• Duration of response

  Through study completion, an average of 3 years.

• Quality of life evaluation

  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.

Study Arms (2)

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).

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).

Other: Sham acupuncture; Drug: Combination of chemotherapy and immunotherapy

Interventions

Acupuncture 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).

Also known as: Electro acupuncture, Acupuncture therapy

Acupuncture

Sham acupuncture 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).

Also known as: Placebo acupuncture

Sham acupuncture

Combination of chemotherapy and immunotherapy 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.

Acupuncture; Sham acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: collaborator
• Jiangsu Province Hospital of Traditional Chinese Medicine: collaborator
• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (3)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 34830, China

RECRUITING

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510000, China

RECRUITING

Jiangsu Provincial Hospital of Chinese Medicine

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Acupuncture Therapy; Immunotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Immunomodulation; Biological Therapy

Study Officials

• Haibo Zhang

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanjuan Zhu, MD

CONTACT

86 20 81887233; zyjsophy@gzucm.edu.cn

Xiwu Rao, MD

CONTACT

86 20 81887233; 18851823395@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 13, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)