Acupuncture with PD‑1/PD‑L1 immunotherapy for advanced lung cancer

Effectiveness of Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer：A Randomized Controlled Clinical Study

This trial will test whether adding acupuncture to PD‑1/PD‑L1 immunotherapy plus chemotherapy helps people with advanced lung cancer have better tumor responses and fewer side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 3 sites (Hefei, Anhui and 2 other locations)
• Trial ID: NCT06926140 on ClinicalTrials.gov

What this trial studies

Patients receiving first-line PD‑1/PD‑L1 inhibitors combined with chemotherapy are randomized to receive either true acupuncture or sham acupuncture for four cycles in addition to standard anti-tumor care. The study compares objective response rates and treatment-related adverse events between the two groups, with follow-up every three weeks for the first three months and then every three months thereafter. Eligible participants are adults with advanced lung cancer, ECOG 0–1, measurable disease, PD‑L1 TPS <50%, and specific molecular testing requirements for adenocarcinoma, plus a Traditional Chinese Medicine diagnosis of Qi Depression. The trial is conducted at several hospitals in China and uses sham control to blind acupuncture effects.

Who should consider this trial

Good fit: Adults 18–75 with advanced NSCLC (stage IIIB–IV) or extensive-stage SCLC, PD‑L1 TPS <50%, ECOG 0–1, measurable disease, no prior systemic therapy, and suitable for first-line PD‑1/PD‑L1 inhibitor plus chemotherapy who meet a TCM diagnosis of Qi Depression.

Not a fit: Patients with actionable driver mutations (for adenocarcinoma), prior systemic therapy, poor performance status, or those unable to attend study sites in China are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, adding acupuncture could increase the immunotherapy response rate and reduce treatment side effects, improving outcomes and quality of life for patients with advanced lung cancer.

How similar studies have performed: Some small studies suggest acupuncture can reduce treatment-related symptoms and affect immune markers, but evidence that it improves objective responses to PD‑1/PD‑L1 therapy in advanced lung cancer is limited and largely untested.

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.

Where this trial is running

Hefei, Anhui and 2 other locations

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine — Beijing, Beijing Municipality, China (Recruiting)
• Hunan Provincial Integrated Traditional Chinese and Western Medicine Hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Jiarong FAN

Conditions Lung Cancers; lung cancer; acupuncture; immunotherapy