Impact of Exercise on Tumor Immunity in NSCLC Patients Receiving Neoadjuvant Chemo-Immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether adding a prescribed physical activity program during neoadjuvant chemo-immunotherapy can increase CD8+ T cells within the tumor microenvironment. It targets adults with locally advanced, resectable NSCLC who are PD-L1 positive and eligible for the neoadjuvant approach. The trial will monitor immune changes in tumor tissue and assess feasibility and adherence to the exercise regimen. Results could inform whether exercise helps enhance treatment effectiveness before surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Léon Berard (CLB)
  Lyon, Rhône, France Recruiting
• Hopitaux Nord Ouest
  Villefranche-sur-Saône, France Recruiting

Study contacts

• Study coordinator: Manon GOUEZ, Phd
• Email: manon.gouez@lyon.unicancer.fr
• Phone: 0033451304860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.