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Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study | Clinical Trials | Clareo Health

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Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study

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

NCT06461338•Guangzhou University of Traditional Chinese Medicine

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Has a histologically-confirmed or cytologically confirmed diagnosis of stage IIIB or IV NSCLC.
•2. PD-L1 TPS\<50%
•3. EGFR/ALK wild-type
•4. 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.
•5. Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
•6. Age≥18 years
•7. Has a life expectancy of at least 3 months
•8. Has measurable disease
•9. Has adequate organ function
•10. Voluntarily enrolled into the study, sign the informed consent form and have good compliance

Exclusion Criteria

•1. Unable to complete baseline assessments
•2. Expected to receive radiotherapy within the next 4 cycles
•3. With a combination of serious primary diseases of the heart, cerebrovascular, hepatic, renal, and hematopoietic systems
•4. With dementia, neurological disorders, mental retardation, or language impairment, and pregnant or breastfeeding women
•5. Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs
•6. Combined with a primary tumor from other sites
•7. Had participated in any other clinical trial within the prior 3 months
•8. Has known history of Human Immunodeficiency Virus (HIV) or solid organ transplantation
•9. With legal incapacity
•10. With skin breakdown at the acupuncture point that interferes with treatment
+8 more criteria

Locations (3)

The First Affiliated Hospital of Guangzhou University of Chinese Medicine.

Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Jiangsu Provincial Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Key Dates

Start Date

August 15, 2024

Primary Completion Date

July 1, 2026

Completion Date

September 1, 2026

Last Updated

December 17, 2025

Enrollment

ESTIMATED participants

Conditions

Non-small Cell Lung CancerNon-Small-Cell Lung Carcinoma

Interventions

acupuncture

PROCEDURE

Sham acupuncture

PROCEDURE

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Non-small Cell Lung Cancer

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RECRUITINGPHASE3

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Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)