Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study (NCT06461338) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study
China60 participantsStarted 2024-08-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
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
What they're measuring
1
Progression free survival
Timeframe: 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.
Trial details
NCT IDNCT06461338
SponsorGuangzhou University of Traditional Chinese Medicine