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ERICA-02 Study : Impact of Physical Exercise on the Tumor Immune Microenvironment in Patients Treated With Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cancer (ERICA-02)

2026年8月25日 更新者：Centre Leon Berard
Recent advances combining chemotherapy and immunotherapy before surgery have significantly improved outcomes for patients with resectable non-small cell lung cancer (NSCLC). However, a substantial proportion of patients still do not respond optimally to these treatments. Researchers believe that physical activity may help strengthen the immune system and favorably modify the tumor microenvironment, potentially improving treatment effectiveness. ERICA-02 aims to investigate this hypothesis.The primary objective of ERICA-02 is to evaluate whether a structured exercise program performed during neoadjuvant chemo-immunotherapy can increase the presence of CD8+ cytotoxic T lymphocytes within the tumor. These immune cells play a key role in recognizing and destroying cancer cells and are considered an important marker of anti-tumor immune response.The study is designed for adults with locally advanced, resectable non-small cell lung cancer who are eligible for neoadjuvant chemo-immunotherapy followed by surgery. Participants must be medically fit to engage in physical activity, able to comply with study procedures, and provide informed consent before enrollment.ERICA-02 is a multicenter, randomized phase II pilot trial involving approximately 40 patients. Participants will be randomly assigned to one of two groups : intervention group and control group. Each participant will be involved in the study for approximately six months, including three months of exercise intervention for patients assigned to the exercise group.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 法国
      • Villefranche-sur-Saône、法国
        • Hopitaux Nord Ouest
        • 副研究员：
          • Camille SIMON
        • 接触：
        • 副研究员：
          • Luc Odier
        • 副研究员：
          • Christine Dussopt
        • 副研究员：
          • Lionel Falchero
    • Rhône
      • Lyon、Rhône、法国、69373
        • Centre Léon Berard (CLB)
        • 首席研究员：
          • Aurelie Swalduz, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Patients with locally advanced, resectable non-small cell lung cancer (NSCLC), stage IIA (≥ 4 cm) to IIIA according to the TNM classification (American Joint Committee on Cancer, 9th edition)

  • PD-L1 positive
  • ECOG performance status of 0 or 1 at diagnosis
  • Sufficient tumor material for the analyses planned by the study Note: The amount of available material must be validated by the coordinating center before patient enrollment
  • With measurable disease according to RECIST version 1.1 criteria
  • Recently diagnosed and eligible for neoadjuvant chemotherapy-immunotherapy, as decided by the multidisciplinary tumor board (MTB)
  • Having obtained medical certification of fitness to engage in physical activity, issued by the referring oncologist or the principal investigator
  • Willing and deemed likely to comply with the intervention and visit schedule and follow-up examinations throughout the duration of the study
  • Able to understand, read, and speak French
  • Affiliated with a social security scheme
  • Having been informed about the study and having signed an informed consent form

Exclusion Criteria:

  • Activating EGFR mutations or ALK translocations, as well as those who have received prior chemotherapy, immunotherapy, or radiotherapy for their current lung cancer
  • History of cancer within the last 5 years
  • Uncontrolled cardiovascular disease, including heart failure, unstable coronary artery disease, severe arrhythmias, or uncontrolled hypertension that could limit participation in physical activity, according to the investigator
  • Uncontrolled type 2 diabetes despite appropriate treatment
  • Severe limiting pulmonary disease such as GOLD stage IV chronic obstructive pulmonary disease, or severe restrictive lung disease
  • Major neuropsychiatric disorders that could hinder participation in the program (e.g., dementia, Alzheimer's disease, advanced Parkinson's disease)
  • Severe physical disability or any other medical condition that contraindicates participation in an exercise program • Concurrent participation in another physical activity study
  • Pregnant woman
  • Person deprived of liberty by judicial or administrative decision, or adult protected by law

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Physical Activity Recommendations
行为的：身体活动建议
在基线阶段，所有参与者都将收到有关促进普通人群健康的身体活动方面的国际建议。
实验性的：Supervised Physical Activity Program
行为的：身体活动建议
在基线阶段，所有参与者都将收到有关促进普通人群健康的身体活动方面的国际建议。
行为的：Physical Activity (PA) Intervention

The exercise programme is carried out during the neoadjuvant period (9 to 12 weeks), alongside the three cycles of chemo-immunotherapy. Participants are provided with an exercise bike and a heart rate monitor.

The programme is structured in three progressive phases: adaptation (weeks 1 to 3, light to moderate intensity), progression (weeks 4 to 6, increased intensity and introduction of interval training) and maintenance/optimisation (from week 7 until surgery, stabilisation of the training load).

Outside the treatment weeks, participants undertake one supervised strength training session each week via videoconference and two independent aerobic sessions on an exercise bike. During each treatment session (C1, C2, C3), a supervised session combining aerobic exercise and strength training is carried out whilst the infusion is in progress.A weekly telephone follow-up allows the programme to be adjusted and enables the collection of assessments of fatigue and perceived exertion.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Evaluate the effect of a structured exercise program on immune pathological response (irPR)
大体时间：T2 (pre-surgery):
Impact of structured exercise on the tumor immune microenvironment in patients receiving neoadjuvant chemo-immunotherapy. The primary endpoint is the density of CD8+ cytotoxic T lymphocytes (cells/mm²) within the tumor on the surgical specimen.
T2 (pre-surgery):

次要结果测量

结果测量
措施说明
大体时间
Evaluate changes in the tumor immune microenvironment
大体时间：Mainly pre surgery (T2), compared with baseline biopsy collected at inclusion (T1).
Assessment of stromal CD8+ CTL density, plasma cells (CD138/MUM1), mature tertiary lymphoid structures (CD20/CD23), and CTL/Treg (FOXP3) ratio.
Mainly pre surgery (T2), compared with baseline biopsy collected at inclusion (T1).
Objective Response Rate (ORR)
大体时间：From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
Evaluate tumor response to neoadjuvant treatment.
From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
Pathological Complete Response (pCR)
大体时间：T2 (surgery)
Assess the absence of viable tumor cells in the surgical specimen.
T2 (surgery)
Major Pathological Response (MPR)
大体时间：T2 (surgery).
Evaluate residual tumor burden following neoadjuvant therapy.
T2 (surgery).
Disease-Free Survival (DFS)
大体时间：T3 (6 weeks post-surgery) and T4 (3 months post-surgery).
Evaluate recurrence-free survival following treatment.
T3 (6 weeks post-surgery) and T4 (3 months post-surgery).
Treatment-Related Toxicities
大体时间：During the first, second, and third cycles of neoadjuvant chemotherapy ( Each cycle is separated by 21 days).
Incidence, nature, and severity of adverse events according to CTCAE v5.0.
During the first, second, and third cycles of neoadjuvant chemotherapy ( Each cycle is separated by 21 days).
Postoperative Complications
大体时间：T3 (6 weeks post-surgery).
Incidence and severity of postoperative complications according to Clavien-Dindo classification.
T3 (6 weeks post-surgery).
Length of Postoperative Hospital Stay
大体时间：Assessed 6 weeks after surgery (T3)
Number of hospital days following surgery.
Assessed 6 weeks after surgery (T3)
90-Day Postoperative Mortality
大体时间：T4 (3 months post-surgery).
Mortality occurring within 90 days after surgery.
T4 (3 months post-surgery).
Change in Aerobic Capacity
大体时间：at study inclusion and at the pre-surgery visit.
Measurement of submaximal oxygen consumption.
at study inclusion and at the pre-surgery visit.
Change in Peripheral Muscle Strength
大体时间：at study inclusion and at the pre-surgery visit.
Assessment of quadriceps isometric strength and core endurance (plank test).
at study inclusion and at the pre-surgery visit.
Change in Functional Capacity
大体时间：at study inclusion and at the pre-surgery visit.
Six-Minute Walk Test (6MWT) and handgrip strength.
at study inclusion and at the pre-surgery visit.
Change in Functionnal capacity
大体时间：at study inclusion and at the pre-surgery visit.
Handgrip test strength.
at study inclusion and at the pre-surgery visit.
Change in Lean and Fat Mass
大体时间：at study inclusion and at the pre-surgery visit.
Body composition analysis using (CT-scan) imaging at the L3 vertebral level and bioimpedance assessment
at study inclusion and at the pre-surgery visit.
Level of physical activity
大体时间：at study inclusion and at the pre-surgery visit.
International Physical Activity Questionnaire (IPAQ) score. The IPAQ assesses physical activity levels based on self-reported frequency and duration of physical activities. Higher scores indicate higher levels of physical activity.
at study inclusion and at the pre-surgery visit.
Change in Quality of Life
大体时间：at study inclusion and at the pre-surgery visit.
Evaluation using EORTC QLQ-F17
at study inclusion and at the pre-surgery visit.
Change of quality of life
大体时间：at study inclusion and at the pre-surgery visit.
Evaluation using EORTC QLQ-LC13 questionnaires.
at study inclusion and at the pre-surgery visit.
Change in Cancer-Related Fatigue
大体时间：at study inclusion and at the pre-surgery visit.
Assessment using the FACT-Fatigue questionnaire.
at study inclusion and at the pre-surgery visit.
Change in Circulating Immune and Inflammatory Biomarkers
大体时间：At study inclusion, during the second cycle of neoadjuvant chemotherapy(Each cycle is separated by 21 days) and before surgery
Analysis of cytokines and myeloid/lymphoid cell populations using flow cytometry and MSD technology.
At study inclusion, during the second cycle of neoadjuvant chemotherapy(Each cycle is separated by 21 days) and before surgery
Participation Rate
大体时间：At screening and 6 months
Proportion of eligible patients enrolled in the study.
At screening and 6 months
Exercise Program Adherence
大体时间：Assessed at study inclusion, during the first, second, and third cycles of neoadjuvant chemotherapy (each cycle is separated by 21 days), and at the pre-surgery visit
Exercise adherence measured as the percentage of prescribed exercise sessions completed. Values range from 0% to 100%, with higher percentages indicating greater adherence.
Assessed at study inclusion, during the first, second, and third cycles of neoadjuvant chemotherapy (each cycle is separated by 21 days), and at the pre-surgery visit
Attrition Rate
大体时间：6 months
Proportion of participants withdrawing from the study.
6 months
Program Acceptability and Satisfaction
大体时间：pre-surgery (T2) : intervention arm only
Participant satisfaction with the exercise intervention, assessed using a self-administered questionnaire developed specifically for this study
pre-surgery (T2) : intervention arm only

其他结果措施

结果测量
措施说明
大体时间
Ancillary - Characterize Exercise-Induced Changes in the Tumor Immune Microenvironment
大体时间：Comparison of tumor samples collected at baseline from the pre-treatment biopsy and at surgery
To identify immune signatures, molecular pathways (immune response, angiogenesis, metabolism), and cellular populations modulated by exercise through RNA sequencing and high-dimensional spatial imaging (Akoya Phenocycler™).
Comparison of tumor samples collected at baseline from the pre-treatment biopsy and at surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centre Leon Berard

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月30日

初级完成 (估计的)

2029年6月30日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2026年8月10日

首先提交符合 QC 标准的

2026年8月25日

首次发布 (实际的)

2026年8月26日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ERICA-02 (ET26-082)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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