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. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Typ studie
Intervenční
Zápis (Odhadovaný)
40
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Manon GOUEZ, Phd
- Telefonní číslo: 0033451304860
- E-mail: manon.gouez@lyon.unicancer.fr
Studijní záloha kontaktů
- Jméno: Meyssane Djebali, Msc
- Telefonní číslo: 003426556743
- E-mail: meyssane.djebali@lyon.unicancer.fr
Studijní místa
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Villefranche-sur-Saône, Francie
- Hopitaux Nord Ouest
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Dílčí vyšetřovatel:
- Camille SIMON
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Kontakt:
- HUET
- Telefonní číslo: +33 474092385
- E-mail: ahuet@hno.fr
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Dílčí vyšetřovatel:
- Luc Odier
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Dílčí vyšetřovatel:
- Christine Dussopt
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Dílčí vyšetřovatel:
- Lionel Falchero
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Rhône
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Lyon, Rhône, Francie, 69373
- Centre Léon Berard (CLB)
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Vrchní vyšetřovatel:
- Aurelie Swalduz, MD
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Kontakt:
- Aurelie Swalduz
- Telefonní číslo: +33 4069856217
- E-mail: aurelie.swalduz@lyon.unicancer.fr
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Physical Activity Recommendations
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Na začátku obdrží všichni účastníci mezinárodní doporučení týkající se fyzické aktivity pro podporu zdraví v obecné populaci.
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Experimentální: Supervised Physical Activity Program
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Na začátku obdrží všichni účastníci mezinárodní doporučení týkající se fyzické aktivity pro podporu zdraví v obecné populaci.
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Evaluate the effect of a structured exercise program on immune pathological response (irPR)
Časové okno: T2 (pre-surgery):
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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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Evaluate changes in the tumor immune microenvironment
Časové okno: Mainly pre surgery (T2), compared with baseline biopsy collected at inclusion (T1).
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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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: at study inclusion and at the pre-surgery visit.
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Ancillary - Characterize Exercise-Induced Changes in the Tumor Immune Microenvironment
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
30. července 2026
Primární dokončení (Odhadovaný)
30. června 2029
Dokončení studie (Odhadovaný)
31. prosince 2029
Termíny zápisu do studia
První předloženo
10. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
25. srpna 2026
První zveřejněno (Aktuální)
26. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
26. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. srpna 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Nemoci dýchacích cest
- Plicní onemocnění
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Chování
- Novotvary plic
- Karcinom, nemalobuněčné plíce
- Motorická aktivita
- Motorická aktivita
- Hnutí
- Muskuloskeletální fyziologické jevy
- Muskuloskeletální a nervové fyziologické jevy
- Vyšetřovací techniky
- Cvičení
- Metody
Další identifikační čísla studie
- ERICA-02 (ET26-082)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
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