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

Overview

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.

Interventions

• Device Acupuncture
  Both groups have a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy); the acupuncture group is combined with acupuncture treatment. The day of starting antitumor treatment for each cycle was D1; D1-D5 was performed by the investigator on the patient for 2 times of acupuncture treatment, once a day; D8-D13 and D15-D20 were operated by patients or family members, and the investigator remotely assisted via video to complete the press needle trea
• Device Sham Comparator
  Both groups have a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy); the sham acupuncture group is combined with sham acupuncture treatment. The day of starting antitumor treatment for each cycle was D1; D1-D5 was performed by the investigator on the patient for 2 times of sham acupuncture treatment, once a day; D8-D13 and D15-D20 were operated by patients or family members, and the investigator remotely assisted via video to complete the sh

Primary outcome measures

• Objective Response Rate [Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred]

Secondary outcome measures (11)

• Disease Control Rate [Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred]
• Progression-Free Survival [Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred]
• Overall Survival [Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred.]
• Eastern Cooperative Oncology Group Performance Status, ECOG PS [Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred]
• GAD-7 [Time frame: At 0,4,7,10,13 weeks,6 months from randomization]
• PHQ-9 [Time frame: At 0,4,7,10,13 weeks,6 months from randomization]
• Insomnia Severity Index [Time frame: At 0, 4, 7, 10, and 13 weeks and 6 and 9 months from randomization]
• Lung Cancer Symptom Scale [Time frame: At 0,4,7,10,13 weeks,6,9 months from randomization]
• weight [Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred]
• adverse event [Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred]
• Duration of immunotherapy [Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until immunotherapy is no longer used]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 3 centers

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

Identifiers

NCT: NCT06926140 · 2024-195-KY

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗