Clinical trial NCT06926140: Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer
Official title: Effectiveness of Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer：A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancers
Keywords: lung cancer
acupuncture
immunotherapy
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be an evaluation of the efficacy and safety of acupuncture to enhance the response rate of immunotherapy in advanced lung cancer. The main questions it aims to answer are 1. Does acupuncture heighten the response rate of immunotherapy in advanced lung cancer? 2. Does acupuncture heighten the safety of immunotherapy in advanced lung cancer? Researchers will compare acupuncture to sham acupuncture to see if acupuncture could enhance the response rate of immunotherapy in advanced lung cancer. Both groups will receive a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy), and the experimental and control groups will be treated with 4 cycles of acupuncture or sham-acupuncture on top of the anti-tumor treatment regimen, respectively. Patients were followed up every three weeks for the first three months and every three months thereafter to record any disease progression, adverse events, survival or mortality status, and so on.


Eligibility criteria: Inclusion criteria:

* Age 18-75 years;
* ECOG/PS score of grade 0-1 and expected survival ≥ 3 months;
* Non-small cell lung cancer AJCC lung cancer staging of stage IIIB-IV, or small cell lung cancer staging of extensive stage;
* PD-L1 immunohistochemistry detection of tumor cell positive proportion score (TPS) \<50%;
* Non-small cell lung cancer adenocarcinoma patients do not have EGFR-sensitive mutations, ALK fusions, ROS1 fusions, BRAFV600 mutations, NTRK fusions, RET fusions, MET14 skipping mutations, and amplified gene-driven mutations by genetic testing;
* Patients with no previous systemic therapy/first-line treatment;
* Patients suitable for chemotherapy combined with immunotherapy;
* Traditional Chinese Medicine (TCM) diagnosis of Qi Depression;
* Having at least 1 measurable tumor lesion (diameter \> 1cm) or lymph node short diameter ≥ 1.5cm;
* Sign the informed consent form and voluntarily participate in this study.

Exclusion criteria:

* Combined with other primary malignant tumors;
* Those who have contraindications to immunotherapy after basic assessment of immunotherapy;
* Those with autoimmune diseases or those who need long-term treatment with systemic steroids or immunosuppressants;
* Those with combined serious and uncontrolled primary diseases of heart, cerebrovascular, liver, kidney, hematopoietic system and so on;
* Those with metal allergy or severe fear of needles;
* Those who are pregnant or breastfeeding;
* Those who are unable to cooperate to complete the assessment due to mental disorder, intellectual or language impairment;
* Those with active severe infectious or inflammatory diseases;
* Those who have received acupuncture treatment or other clinical trials within 1 month prior to randomization;
* In the judgment of the investigator, persons who have a concomitant medical condition that seriously jeopardizes the safety of the participant or interferes with the completion of the study, or who are deemed to have other reasons for not being suitable for enrollment.

Primary outcomes:
measure: Objective Response Rate
timeFrame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred
Secondary outcomes:
measure: Disease Control Rate
timeFrame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred
measure: Progression-Free Survival
timeFrame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred
measure: Overall Survival
timeFrame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred.
measure: Eastern Cooperative Oncology Group Performance Status, ECOG PS
timeFrame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred
measure: GAD-7
timeFrame: At 0,4,7,10,13 weeks,6 months from randomization
measure: PHQ-9
timeFrame: At 0,4,7,10,13 weeks,6 months from randomization
measure: Insomnia Severity Index
timeFrame: At 0, 4, 7, 10, and 13 weeks and 6 and 9 months from randomization
measure: Lung Cancer Symptom Scale
timeFrame: At 0,4,7,10,13 weeks,6,9 months from randomization
measure: weight
timeFrame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred
measure: adverse event
timeFrame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred
measure: Duration of immunotherapy
timeFrame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until immunotherapy is no longer used
Other outcomes:
measure: Assessment of belief in acupuncture
timeFrame: Baseline assessment (week 0)
measure: Blinding assessment Description
timeFrame: Within 5 minutes after either treatment at week 10.
Locations:
Study officials:
References: