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NCT07786909

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

Sponsor: Centre Leon Berard

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-30

Completion Date

2029-12-31

Last Updated

2026-08-26

Healthy Volunteers

Conditions

Lung Neoplasms Non Small Cell Lung Cancer

Interventions

BEHAVIORAL

Physical activity recommendations

At the baseline, all participants will receive the international recommendations in terms of physical activity for promoting health in the general population.

BEHAVIORAL

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.

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

Locations (2)

Centre Léon Berard (CLB)

Lyon, Rhône, France

Hopitaux Nord Ouest

Villefranche-sur-Saône, France