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ClinicalTrials.gov ID

NCT07786909

Lead Sponsor

Centre Leon BerardOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

40Estimated

Last Update Posted

Aug 26, 2026Actual

Start Date

Jul 30, 2026Estimated

Primary Completion Date

Jun 30, 2029Estimated

Completion Date

Dec 31, 2029Estimated

Official Title

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

Brief 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.

• Lung Neoplasms
• Non Small Cell Lung Cancer

• Physical activity recommendations
• Physical Activity (PA) Intervention

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Leon BerardOTHER

ahuet@hno.fr474092385 ext. +33