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)
25 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Manon GOUEZ, Phd
- Numero di telefono: 0033451304860
- Email: manon.gouez@lyon.unicancer.fr
Backup dei contatti dello studio
- Nome: Meyssane Djebali, Msc
- Numero di telefono: 003426556743
- Email: meyssane.djebali@lyon.unicancer.fr
Luoghi di studio
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Villefranche-sur-Saône, Francia
- Hopitaux Nord Ouest
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Sub-investigatore:
- Camille SIMON
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Contatto:
- HUET
- Numero di telefono: +33 474092385
- Email: ahuet@hno.fr
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Sub-investigatore:
- Luc Odier
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Sub-investigatore:
- Christine Dussopt
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Sub-investigatore:
- Lionel Falchero
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Rhône
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Lyon, Rhône, Francia, 69373
- Centre Léon Berard (CLB)
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Investigatore principale:
- Aurelie Swalduz, MD
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Contatto:
- Aurelie Swalduz
- Numero di telefono: +33 4069856217
- Email: aurelie.swalduz@lyon.unicancer.fr
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Physical Activity Recommendations
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Alla linea di base, tutti i partecipanti riceveranno le raccomandazioni internazionali in termini di attività fisica per promuovere la salute nella popolazione generale.
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Sperimentale: Supervised Physical Activity Program
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Alla linea di base, tutti i partecipanti riceveranno le raccomandazioni internazionali in termini di attività fisica per promuovere la salute nella popolazione generale.
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluate the effect of a structured exercise program on immune pathological response (irPR)
Lasso di tempo: 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.
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T2 (pre-surgery):
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluate changes in the tumor immune microenvironment
Lasso di tempo: 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.
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Mainly pre surgery (T2), compared with baseline biopsy collected at inclusion (T1).
|
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Objective Response Rate (ORR)
Lasso di tempo: From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
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Evaluate tumor response to neoadjuvant treatment.
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From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
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Pathological Complete Response (pCR)
Lasso di tempo: T2 (surgery)
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Assess the absence of viable tumor cells in the surgical specimen.
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T2 (surgery)
|
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Major Pathological Response (MPR)
Lasso di tempo: T2 (surgery).
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Evaluate residual tumor burden following neoadjuvant therapy.
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T2 (surgery).
|
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Disease-Free Survival (DFS)
Lasso di tempo: T3 (6 weeks post-surgery) and T4 (3 months post-surgery).
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Evaluate recurrence-free survival following treatment.
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T3 (6 weeks post-surgery) and T4 (3 months post-surgery).
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Treatment-Related Toxicities
Lasso di tempo: During the first, second, and third cycles of neoadjuvant chemotherapy ( Each cycle is separated by 21 days).
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Incidence, nature, and severity of adverse events according to CTCAE v5.0.
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During the first, second, and third cycles of neoadjuvant chemotherapy ( Each cycle is separated by 21 days).
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Postoperative Complications
Lasso di tempo: T3 (6 weeks post-surgery).
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Incidence and severity of postoperative complications according to Clavien-Dindo classification.
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T3 (6 weeks post-surgery).
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Length of Postoperative Hospital Stay
Lasso di tempo: Assessed 6 weeks after surgery (T3)
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Number of hospital days following surgery.
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Assessed 6 weeks after surgery (T3)
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90-Day Postoperative Mortality
Lasso di tempo: T4 (3 months post-surgery).
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Mortality occurring within 90 days after surgery.
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T4 (3 months post-surgery).
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Change in Aerobic Capacity
Lasso di tempo: at study inclusion and at the pre-surgery visit.
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Measurement of submaximal oxygen consumption.
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at study inclusion and at the pre-surgery visit.
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Change in Peripheral Muscle Strength
Lasso di tempo: at study inclusion and at the pre-surgery visit.
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Assessment of quadriceps isometric strength and core endurance (plank test).
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at study inclusion and at the pre-surgery visit.
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Change in Functional Capacity
Lasso di tempo: at study inclusion and at the pre-surgery visit.
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Six-Minute Walk Test (6MWT) and handgrip strength.
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at study inclusion and at the pre-surgery visit.
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Change in Functionnal capacity
Lasso di tempo: at study inclusion and at the pre-surgery visit.
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Handgrip test strength.
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at study inclusion and at the pre-surgery visit.
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Change in Lean and Fat Mass
Lasso di tempo: at study inclusion and at the pre-surgery visit.
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Body composition analysis using (CT-scan) imaging at the L3 vertebral level and bioimpedance assessment
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at study inclusion and at the pre-surgery visit.
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Level of physical activity
Lasso di tempo: at study inclusion and at the pre-surgery visit.
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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.
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at study inclusion and at the pre-surgery visit.
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Change in Quality of Life
Lasso di tempo: at study inclusion and at the pre-surgery visit.
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Evaluation using EORTC QLQ-F17
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at study inclusion and at the pre-surgery visit.
|
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Change of quality of life
Lasso di tempo: at study inclusion and at the pre-surgery visit.
|
Evaluation using EORTC QLQ-LC13 questionnaires.
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at study inclusion and at the pre-surgery visit.
|
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Change in Cancer-Related Fatigue
Lasso di tempo: at study inclusion and at the pre-surgery visit.
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Assessment using the FACT-Fatigue questionnaire.
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at study inclusion and at the pre-surgery visit.
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Change in Circulating Immune and Inflammatory Biomarkers
Lasso di tempo: At study inclusion, during the second cycle of neoadjuvant chemotherapy(Each cycle is separated by 21 days) and before surgery
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Analysis of cytokines and myeloid/lymphoid cell populations using flow cytometry and MSD technology.
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At study inclusion, during the second cycle of neoadjuvant chemotherapy(Each cycle is separated by 21 days) and before surgery
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Participation Rate
Lasso di tempo: At screening and 6 months
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Proportion of eligible patients enrolled in the study.
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At screening and 6 months
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Exercise Program Adherence
Lasso di tempo: 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
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Exercise adherence measured as the percentage of prescribed exercise sessions completed.
Values range from 0% to 100%, with higher percentages indicating greater adherence.
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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
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Attrition Rate
Lasso di tempo: 6 months
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Proportion of participants withdrawing from the study.
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6 months
|
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Program Acceptability and Satisfaction
Lasso di tempo: pre-surgery (T2) : intervention arm only
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Participant satisfaction with the exercise intervention, assessed using a self-administered questionnaire developed specifically for this study
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pre-surgery (T2) : intervention arm only
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Ancillary - Characterize Exercise-Induced Changes in the Tumor Immune Microenvironment
Lasso di tempo: Comparison of tumor samples collected at baseline from the pre-treatment biopsy and at surgery
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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™).
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Comparison of tumor samples collected at baseline from the pre-treatment biopsy and at surgery
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
30 luglio 2026
Completamento primario (Stimato)
30 giugno 2029
Completamento dello studio (Stimato)
31 dicembre 2029
Date di iscrizione allo studio
Primo inviato
10 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
25 agosto 2026
Primo Inserito (Effettivo)
26 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 agosto 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Malattie delle vie respiratorie
- Malattie polmonari
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Comportamento
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Attività motoria
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Tecniche investigative
- Esercizio
- Metodi
Altri numeri di identificazione dello studio
- ERICA-02 (ET26-082)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .