ERICA-02 Study : Impact of Physical Exercise on the Tumor Immune Microenvironment in Patients Treated With Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Evaluate the effect of a structured exercise program on immune pathological response (irPR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluate the effect of a structured exercise program on immune pathological response (irPR)
时间窗: 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.
次要结局
- Change in Quality of Life(at study inclusion and at the pre-surgery visit.)
- Attrition Rate(6 months)
- Evaluate changes in the tumor immune microenvironment(Mainly pre surgery (T2), compared with baseline biopsy collected at inclusion (T1).)
- Objective Response Rate (ORR)(From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery)
- Pathological Complete Response (pCR)(T2 (surgery))
- Major Pathological Response (MPR)(T2 (surgery).)
- Disease-Free Survival (DFS)(T3 (6 weeks post-surgery) and T4 (3 months post-surgery).)
- Treatment-Related Toxicities(During the first, second, and third cycles of neoadjuvant chemotherapy ( Each cycle is separated by 21 days).)
- Postoperative Complications(T3 (6 weeks post-surgery).)
- Length of Postoperative Hospital Stay(Assessed 6 weeks after surgery (T3))
- 90-Day Postoperative Mortality(T4 (3 months post-surgery).)
- Change in Aerobic Capacity(at study inclusion and at the pre-surgery visit.)
- Change in Peripheral Muscle Strength(at study inclusion and at the pre-surgery visit.)
- Change in Functional Capacity(at study inclusion and at the pre-surgery visit.)
- Change in Functionnal capacity(at study inclusion and at the pre-surgery visit.)
- Change in Lean and Fat Mass(at study inclusion and at the pre-surgery visit.)
- Level of physical activity(at study inclusion and at the pre-surgery visit.)
- Change of quality of life(at study inclusion and at the pre-surgery visit.)
- Change in Cancer-Related Fatigue(at study inclusion and at the pre-surgery visit.)
- Change in Circulating Immune and Inflammatory Biomarkers(At study inclusion, during the second cycle of neoadjuvant chemotherapy(Each cycle is separated by 21 days) and before surgery)
- Participation Rate(At screening and 6 months)
- Exercise Program 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)
- Program Acceptability and Satisfaction(pre-surgery (T2) : intervention arm only)