Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study

NCT06461338 | Active Not Recruiting

• 1 other identifier: 2023YFC3503303
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Non-small Cell Lung Cancer; Non-Small-Cell Lung Carcinoma

Keywords

Non-Small Cell Lung Cancer; Acupuncture; Immune Checkpoint Inhibitors; Effect; Safety

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  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

  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 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.

Other Outcomes (5)

• Next-generation sequencing

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

• Cytometry by time-of-flight

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

• Tumor markers

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

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture for 4 times every 3 weeks (one cycle of ICIs combined with chemotherapy) for 12 weeks (4 cycles of ICIs combined with chemotherapy)

Procedure: acupuncture

Sham acupuncture

SHAM COMPARATOR

Sham acupuncture for 4 times every 3 weeks (one cycle of ICIs combined with chemotherapy) for 12 weeks (4 cycles of ICIs combined with chemotherapy)

Procedure: Sham acupuncture

Interventions

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).

Sham acupuncture

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).

Acupuncture

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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)

The First Affiliated Hospital of Guangzhou University of Chinese Medicine.

Guangzhou, Guangdong, 510000, China

Location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Jiangsu Provincial Hospital of Chinese Medicine

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Acupuncture Therapy

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

Study Officials

• Haibo Zhang, M.D.

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

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: June 10, 2024
• First Posted: June 17, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

CN (3)