NCT06926140Recruiting
Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer
Effectiveness of Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer：A Randomized Controlled Clinical Study
Source: ClinicalTrials.gov · Last updated 24 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 31 Mar 2025
- Start date
- 21 Jun 2025
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Diseases
- Lung cancer
- NCT number
- NCT06926140
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 21 Jun 2025 to the primary completion date, 31 Jan 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
Other illness
- Combined with other primary malignant tumors;
- 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 unable to cooperate to complete the assessment due to mental disorder, intellectual or language impairment;
- Those with active severe infectious or inflammatory diseases;
Other
- Those who are pregnant or breastfeeding;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Hunan Provincial Integrated Traditional Chinese and Western Medicine Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.