Electro-Acupuncture in Lung cancER : EALER Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou University of Traditional Chinese Medicine
About this trial
This multicentre, randomized controlled trial evaluates the effect and safety of acupuncture combing with PD-1 inhibitors plus chemotherapy in NSCLC. Participants will be randomly assigned to undergo either acupuncture or sham acupuncture concurrent with the initial four-six cycles of chemotherapy combined with PD-1 inhibitors.
Eligibility criteria
Qualifiers
Pathologically confirmed NSCLC, with AJCC lung cancer TNM stage IV.
Tumor proportion score for PD-L1 < 50%.
Lacks targetable gene mutations (including but not limited to EGFR mutations or ALK fusions).
No prior systemic therapy for advanced NSCLC (including chemotherapy, targeted therapy, or immunotherapy). Patients planned to receive first-line (induction) treatment with ICIs plus chemotherapy are eligible. Patients who have received prior neoadjuvant or adjuvant therapy, or definitive chemoradiotherapy, may be enrolled if provided that disease progression occurred more than 6 months after the completion of the last treatment.
Disqualifiers
Inability to complete baseline assessments.
Pregnant or lactating women, and those with psychiatric, intellectual, or language disorders.
Patients with autoimmune diseases or hematologic disorders requiring long-term use of hormones or immunosuppressants.
Presence of concurrent primary malignant tumors at other sites.
Trial design
Treatments tested in this trial
- Acupuncture
- Sham acupuncture
- Combination of chemotherapy and immunotherapy
Treatment groups
424 Participants
are divided into 2 treatment groupsSponsors and collaborators
Guangzhou University of Traditional Chinese Medicine
Lead sponsor
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Collaborator
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborator
Source ClinicalTrials.gov