NCT06461338Active, not recruiting
Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study
Acupuncture for Enhancing the Effect of Immunotherapy in Advanced NSCLC: a Pilot Study
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 Jun 2024
- Start date
- 15 Aug 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Diseases
- Lung cancer
- NCT number
- NCT06461338
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 15 Aug 2024 to the primary completion date, Jul 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Expected to receive radiotherapy within the next 4 cycles
- Had participated in any other clinical trial within the prior 3 months
- Had received acupuncture treatment within 6 weeks
- Has fever (\>38°C) or clinically significant infection within 1 week prior to enrolment
- With a bleeding tendency, and receiving thrombolytics or anticoagulants
Other illness
- 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
- Has known history of Human Immunodeficiency Virus (HIV) or solid organ transplantation
- 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 active tuberculosis or indications of severe or uncontrolled systemic diseases
Other
- Unable to complete baseline assessments
- Combined with a primary tumor from other sites
- With legal incapacity
- With skin breakdown at the acupuncture point that interferes with treatment
- With a pacemaker
- With a fear of acupuncture
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Jiangsu Provincial Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.