Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study

Non-small Cell Lung Cancer Clinical Trial

Official title:

Acupuncture for Enhancing the Effect of Immunotherapy in Advanced NSCLC: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06461338
• Other study ID #: 2023YFC3503303
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2026

Study information

• Verified date: June 2024
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Yanjuan Zhu, M.D.
• Phone: 86 20 81887233
• Email: zyjsophy[@]gzucm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer
• Non-Small-Cell Lung Carcinoma

Intervention

Procedure:
• acupuncture
Acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Danzhong (RN17), Baihui (DU20), Yintang (GV29), combined with electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).
• Sham acupuncture
Sham acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Danzhong (RN17), Baihui (DU20), Yintang (GV29), combined with sham electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou University of Chinese Medicine.	Guangzhou	Guangdong
China	Jiangsu Provincial Hospital of Chinese Medicine	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine	Jiangsu Province Hospital of Traditional Chinese Medicine, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.