Clinical trial · Interventional
Acupuncture for Enhancing Immunotherapy in Advanced NSCLC:a Pilot Study
Acupuncture for Enhancing the Effect of Immunotherapy in Advanced NSCLC: a Pilot Study
NCT06461338CI-TRIAL-00099164active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-Small-Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acupuncture | Procedure | — | UNRESOLVED |
| Sham acupuncture | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acupuncture
- description
- Acupuncture for 4 times every 3 weeks (one cycle of ICIs combined with chemotherapy) for 12 weeks (4 cycles of ICIs combined with chemotherapy)
- interventionNames
- Procedure: acupuncture
- type
- SHAM_COMPARATOR
- label
- Sham acupuncture
- description
- 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)
- interventionNames
- Procedure: Sham acupuncture
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 11. With a pacemaker 12. With a fear of acupuncture 13. Had received acupuncture treatment within 6 weeks 14. Has known active Hepatitis B 15. Has interstitial lung disease or a history of pneumonitis that required oral of IV glucocorticoids to assist with management 16. Has fever (\>38°C) or clinically significant infection within 1 week prior to enrolment 17. Has active tuberculosis or indications of severe or uncontrolled systemic diseases 18. With a bleeding tendency, and receiving thrombolytics or anticoagulants
References
Publications (0)
Data not yet available
No reference posted for this study.