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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: fjrr1115@163.com
• Phone: 86+88001196

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.