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Electro-Acupuncture in Lung cancER : EALER Study

ConditionsNon Small Cell Lung CancerAccupuncturePD-1 Inhibitors
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Other intervention

    Acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).

  • Sham acupuncture

    Other intervention

    Sham acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with sham electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).

  • Combination of chemotherapy and immunotherapy

    Drug

    For patients with non-squamous cell carcinoma: PD-1 inhibitor plus AP regimen chemotherapy (Pemetrexed + Carboplatin or Cisplatin, every 3 weeks) for 4-6 cycles. For patients with squamous cell carcinoma: PD-1 inhibitor plus TP or GP regimen chemotherapy (Paclitaxel or Liposomal Paclitaxel + Carboplatin or Cisplatin , nab-paclitaxel + Carboplatin or Cisplatin, Gemcitabine + Carboplatin or Cisplatin, every 3 weeks) for 4-6 cycles.

Treatment groups

424 Participants
are divided into 2 treatment groups
Group A: AcupunctureExperimental treatment 2 interventions
Group B: Sham acupuncturePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression free survival

Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of either objective disease progression or death from any cause.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.

Secondary outcomes

1

Overall survival

Overall survival is defined as the time from the date of randomization until death due to any cause

Time frame
From date of randomization until the date of death from any cause, assessed up to 5 years.
2

Objective response rate

Objective response rate (ORR) is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to iRECIST or RECIST V.1.1 criteria

Time frame
Through study completion, an average of 3 years.
3

Disease control rate

Disease control rate is determined by the percentage of patients who achieve CR, PR, or SD as defined by iRECIST or RECIST V.1.1 criteria. This encompasses all instances of CR, PR, and SD (CR + PR + SD).

Time frame
Through study completion, an average of 3 years.
4

Duration of response

Duration of response (DoR) is defined, for patients with a confirmed objective response (CR or PR), as the time from the date of the first documented response until the date of first documented disease progression or death from any cause.

Time frame
Through study completion, an average of 3 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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