Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study
NCT Number: NCT06461338
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-small Cell Lung Cancer|Non-Small-Cell Lung Carcinoma
Interventions: PROCEDURE: acupuncture|PROCEDURE: Sham acupuncture
Sponsor: Guangzhou University of Traditional Chinese Medicine
Collaborators: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine|Jiangsu Province Hospital of Traditional Chinese Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-09
Locations: The First Affiliated Hospital of Guangzhou University of Chinese Medicine., Guangzhou, Guangdong, 510000, China|Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, 510120, China|Jiangsu Provincial Hospital of Chinese Medicine, Nanjing, Jiangsu, 210000, China

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.

Primary Outcome Measures: 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 Outcome Measures: Overall survival, Overall survival is defined as the time until death due to any cause, From date of randomization until the date of death from any cause, assessed up to 5 years.|Objective response rate, Objective response rate is defined as the proportion of patients achieving complete (iCR/CR) or partial (iPR/PR) response according to iRECIST or RECIST V.1.1 criteria, Through study completion, an average of 3 years.|Disease control rate, Disease control rate is determined by the percentage of patients who achieve CR, PR, or SD as defined by iRECIST or RECIST V.1.1 criteria. This encompasses all instances of CR, PR, and SD (CR + PR + SD)., Through study completion, an average of 3 years.|Duration of response, Duration of response is assessed only in patients achieving CR, PR, or nPR and was defined as the time from first assessment showing CR, PR, or nPR to earliest date of either PD or death., Through study completion, an average of 3 years.|Quality of life evaluation, According to the requirements of European Organisation for Research and Treatment of Cancer-quality of life core questionnaire (EORTC QLQ-C30)/Lung cancer 13 items (LC13), the scoring results of each field of the scale were recorded in CRF. The score of this questionnaire ranges between 1 and 4. The higher score indicates the worse quality of life., 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.|Symptom evaluation, According to the requirements of Lung cancer symptom scale (LCSS), the scoring results of each field of the scale were recorded in CRF. The score of this questionnaire ranges between 0 and 10. The higher score indicates the worse symptom., 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 Outcome Measures: Next-generation sequencing, Biopsy/surgery samples were examined histopathologically and for reptarenavirus RNA by qRT-PCR and metagenomic NGS.

Genetic testing of tissue samples was performed by NGS., At the baseline and the date of first documented progression, up to approximately 36 months.|Cytometry by time-of-flight, Cells were analyzed using a CyTOF mass cytometer, At the baseline and the date of first documented progression, up to approximately 36 months.|Tumor markers, Detection of tumor markers including serum carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), squamous cell carcinoma (SCC), carbohydrate antigen 125 (CA125) and cytokeratin 19 fragment (CyFRA21-1)., At the baseline and the date of first documented progression, up to approximately 36 months.|Pro-inflammatory index, Pro-inflammatory index were measured from the peripheral blood., At the baseline and the date of first documented progression, up to approximately 36 months.|The traditional Chinese medicine syndrome evaluation, The data related to Chinese medicine syndrome types will be extracted, including symptoms and signs, tongue, pulse, and other syndrome information., At the baseline, the end of Cycle 2 (each cycle is 21 days), and day 1 of Cycle 5 (each cycle is 21 days), up to approximately 6 months.