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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 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Frankrijk
      • Villefranche-sur-Saône, Frankrijk
        • Hopitaux Nord Ouest
        • Onderonderzoeker:
          • Camille SIMON
        • Contact:
        • Onderonderzoeker:
          • Luc Odier
        • Onderonderzoeker:
          • Christine Dussopt
        • Onderonderzoeker:
          • Lionel Falchero
    • Rhône
      • Lyon, Rhône, Frankrijk, 69373

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Physical Activity Recommendations
Gedragsmatig: Aanbevelingen voor lichaamsbeweging
Bij de nulmeting ontvangen alle deelnemers de internationale aanbevelingen op het gebied van lichaamsbeweging ter bevordering van de gezondheid van de algemene bevolking.
Experimenteel: Supervised Physical Activity Program
Gedragsmatig: Aanbevelingen voor lichaamsbeweging
Bij de nulmeting ontvangen alle deelnemers de internationale aanbevelingen op het gebied van lichaamsbeweging ter bevordering van de gezondheid van de algemene bevolking.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluate the effect of a structured exercise program on immune pathological response (irPR)
Tijdsspanne: 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.
T2 (pre-surgery):

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluate changes in the tumor immune microenvironment
Tijdsspanne: 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.
Mainly pre surgery (T2), compared with baseline biopsy collected at inclusion (T1).
Objective Response Rate (ORR)
Tijdsspanne: From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
Evaluate tumor response to neoadjuvant treatment.
From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
Pathological Complete Response (pCR)
Tijdsspanne: T2 (surgery)
Assess the absence of viable tumor cells in the surgical specimen.
T2 (surgery)
Major Pathological Response (MPR)
Tijdsspanne: T2 (surgery).
Evaluate residual tumor burden following neoadjuvant therapy.
T2 (surgery).
Disease-Free Survival (DFS)
Tijdsspanne: T3 (6 weeks post-surgery) and T4 (3 months post-surgery).
Evaluate recurrence-free survival following treatment.
T3 (6 weeks post-surgery) and T4 (3 months post-surgery).
Treatment-Related Toxicities
Tijdsspanne: During the first, second, and third cycles of neoadjuvant chemotherapy ( Each cycle is separated by 21 days).
Incidence, nature, and severity of adverse events according to CTCAE v5.0.
During the first, second, and third cycles of neoadjuvant chemotherapy ( Each cycle is separated by 21 days).
Postoperative Complications
Tijdsspanne: T3 (6 weeks post-surgery).
Incidence and severity of postoperative complications according to Clavien-Dindo classification.
T3 (6 weeks post-surgery).
Length of Postoperative Hospital Stay
Tijdsspanne: Assessed 6 weeks after surgery (T3)
Number of hospital days following surgery.
Assessed 6 weeks after surgery (T3)
90-Day Postoperative Mortality
Tijdsspanne: T4 (3 months post-surgery).
Mortality occurring within 90 days after surgery.
T4 (3 months post-surgery).
Change in Aerobic Capacity
Tijdsspanne: at study inclusion and at the pre-surgery visit.
Measurement of submaximal oxygen consumption.
at study inclusion and at the pre-surgery visit.
Change in Peripheral Muscle Strength
Tijdsspanne: at study inclusion and at the pre-surgery visit.
Assessment of quadriceps isometric strength and core endurance (plank test).
at study inclusion and at the pre-surgery visit.
Change in Functional Capacity
Tijdsspanne: at study inclusion and at the pre-surgery visit.
Six-Minute Walk Test (6MWT) and handgrip strength.
at study inclusion and at the pre-surgery visit.
Change in Functionnal capacity
Tijdsspanne: at study inclusion and at the pre-surgery visit.
Handgrip test strength.
at study inclusion and at the pre-surgery visit.
Change in Lean and Fat Mass
Tijdsspanne: at study inclusion and at the pre-surgery visit.
Body composition analysis using (CT-scan) imaging at the L3 vertebral level and bioimpedance assessment
at study inclusion and at the pre-surgery visit.
Level of physical activity
Tijdsspanne: at study inclusion and at the pre-surgery visit.
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.
at study inclusion and at the pre-surgery visit.
Change in Quality of Life
Tijdsspanne: at study inclusion and at the pre-surgery visit.
Evaluation using EORTC QLQ-F17
at study inclusion and at the pre-surgery visit.
Change of quality of life
Tijdsspanne: at study inclusion and at the pre-surgery visit.
Evaluation using EORTC QLQ-LC13 questionnaires.
at study inclusion and at the pre-surgery visit.
Change in Cancer-Related Fatigue
Tijdsspanne: at study inclusion and at the pre-surgery visit.
Assessment using the FACT-Fatigue questionnaire.
at study inclusion and at the pre-surgery visit.
Change in Circulating Immune and Inflammatory Biomarkers
Tijdsspanne: At study inclusion, during the second cycle of neoadjuvant chemotherapy(Each cycle is separated by 21 days) and before surgery
Analysis of cytokines and myeloid/lymphoid cell populations using flow cytometry and MSD technology.
At study inclusion, during the second cycle of neoadjuvant chemotherapy(Each cycle is separated by 21 days) and before surgery
Participation Rate
Tijdsspanne: At screening and 6 months
Proportion of eligible patients enrolled in the study.
At screening and 6 months
Exercise Program Adherence
Tijdsspanne: 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
Exercise adherence measured as the percentage of prescribed exercise sessions completed. Values range from 0% to 100%, with higher percentages indicating greater adherence.
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
Attrition Rate
Tijdsspanne: 6 months
Proportion of participants withdrawing from the study.
6 months
Program Acceptability and Satisfaction
Tijdsspanne: pre-surgery (T2) : intervention arm only
Participant satisfaction with the exercise intervention, assessed using a self-administered questionnaire developed specifically for this study
pre-surgery (T2) : intervention arm only

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Ancillary - Characterize Exercise-Induced Changes in the Tumor Immune Microenvironment
Tijdsspanne: Comparison of tumor samples collected at baseline from the pre-treatment biopsy and at surgery
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™).
Comparison of tumor samples collected at baseline from the pre-treatment biopsy and at surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centre Leon Berard

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 juli 2026

Primaire voltooiing (Geschat)

30 juni 2029

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

10 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 augustus 2026

Eerst geplaatst (Werkelijk)

26 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

25 augustus 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ERICA-02 (ET26-082)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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