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NCT Number: NCT06461338

Acupuncture for Enhancing 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-Small-Cell Lung Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Acupuncture

Procedure

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 acupuncture

Procedure

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. Overall survival

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

    Overall survival is defined as the time until death due to any cause

  2. Objective response rate

    Time frame: Through study completion, an average of 3 years.

    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

  3. Disease control rate

    Time frame: Through study completion, an average of 3 years.

    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).

  4. Duration of response

    Time frame: Through study completion, an average of 3 years.

    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.

  5. 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.

    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.

  6. 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.

    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.

Other outcomes

  1. Next-generation sequencing

    Time frame: At the baseline and the date of first documented progression, up to approximately 36 months.

    Biopsy/surgery samples were examined histopathologically and for reptarenavirus RNA by qRT-PCR and metagenomic NGS.

    Genetic testing of tissue samples was performed by NGS.

  2. Cytometry by time-of-flight

    Time frame: At the baseline and the date of first documented progression, up to approximately 36 months.

    Cells were analyzed using a CyTOF mass cytometer

  3. Tumor markers

    Time frame: At the baseline and the date of first documented progression, up to approximately 36 months.

    Detection of tumor markers including serum carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), squamous cell carcinoma (SCC), carbohydrate antigen 125 (CA125) and cytokeratin 19 fragment (CyFRA21-1).

  4. Pro-inflammatory index

    Time frame: At the baseline and the date of first documented progression, up to approximately 36 months.

    Pro-inflammatory index were measured from the peripheral blood.

  5. The traditional Chinese medicine syndrome evaluation

    Time frame: At the baseline, the end of Cycle 2 (each cycle is 21 days), and day 1 of Cycle 5 (each cycle is 21 days), up to approximately 6 months.

    The data related to Chinese medicine syndrome types will be extracted, including symptoms and signs, tongue, pulse, and other syndrome information.

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Collaborators

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

Registry information

Official study title

Acupuncture for Enhancing the Effect of Immunotherapy in Advanced NSCLC: a Pilot Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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