Clinical trial NCT06461338: Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study
Official title: Acupuncture for Enhancing the Effect of Immunotherapy in Advanced NSCLC: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer
Non-Small-Cell Lung Carcinoma
Keywords: Non-Small Cell Lung Cancer
Acupuncture
Immune Checkpoint Inhibitors
Effect
Safety
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Jiangsu Province Hospital of Traditional Chinese Medicine
First posted: 2024-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 5 years.
measure: Objective response rate
timeFrame: Through study completion, an average of 3 years.
measure: Disease control rate
timeFrame: Through study completion, an average of 3 years.
measure: Duration of response
timeFrame: Through study completion, an average of 3 years.
measure: Quality of life evaluation
timeFrame: 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.
measure: Symptom evaluation
timeFrame: 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:
measure: Next-generation sequencing
timeFrame: At the baseline and the date of first documented progression, up to approximately 36 months.
measure: Cytometry by time-of-flight
timeFrame: At the baseline and the date of first documented progression, up to approximately 36 months.
measure: Tumor markers
timeFrame: At the baseline and the date of first documented progression, up to approximately 36 months.
measure: Pro-inflammatory index
timeFrame: At the baseline and the date of first documented progression, up to approximately 36 months.
measure: The traditional Chinese medicine syndrome evaluation
timeFrame: 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.
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine.
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Chinese Medicine
state: Jiangsu
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Haibo Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: