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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. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Frankrike
      • Villefranche-sur-Saône, Frankrike
        • Hopitaux Nord Ouest
        • Underetterforsker:
          • Camille SIMON
        • Ta kontakt med:
        • Underetterforsker:
          • Luc Odier
        • Underetterforsker:
          • Christine Dussopt
        • Underetterforsker:
          • Lionel Falchero
    • Rhône
      • Lyon, Rhône, Frankrike, 69373
        • Centre Léon Berard (CLB)
        • Hovedetterforsker:
          • Aurelie Swalduz, MD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Physical Activity Recommendations
Atferdsmessig: Anbefalinger om fysisk aktivitet
Ved baseline vil alle deltakere motta de internasjonale anbefalingene når det gjelder fysisk aktivitet for å fremme helse i befolkningen generelt.
Eksperimentell: Supervised Physical Activity Program
Atferdsmessig: Anbefalinger om fysisk aktivitet
Ved baseline vil alle deltakere motta de internasjonale anbefalingene når det gjelder fysisk aktivitet for å fremme helse i befolkningen generelt.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluate the effect of a structured exercise program on immune pathological response (irPR)
Tidsramme: 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):

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluate changes in the tumor immune microenvironment
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: T2 (surgery)
Assess the absence of viable tumor cells in the surgical specimen.
T2 (surgery)
Major Pathological Response (MPR)
Tidsramme: T2 (surgery).
Evaluate residual tumor burden following neoadjuvant therapy.
T2 (surgery).
Disease-Free Survival (DFS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Assessed 6 weeks after surgery (T3)
Number of hospital days following surgery.
Assessed 6 weeks after surgery (T3)
90-Day Postoperative Mortality
Tidsramme: T4 (3 months post-surgery).
Mortality occurring within 90 days after surgery.
T4 (3 months post-surgery).
Change in Aerobic Capacity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At screening and 6 months
Proportion of eligible patients enrolled in the study.
At screening and 6 months
Exercise Program Adherence
Tidsramme: 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
Tidsramme: 6 months
Proportion of participants withdrawing from the study.
6 months
Program Acceptability and Satisfaction
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Ancillary - Characterize Exercise-Induced Changes in the Tumor Immune Microenvironment
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Leon Berard

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. juli 2026

Primær fullføring (Antatt)

30. juni 2029

Studiet fullført (Antatt)

31. desember 2029

Datoer for studieregistrering

Først innsendt

10. august 2026

Først innsendt som oppfylte QC-kriteriene

25. august 2026

Først lagt ut (Faktiske)

26. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ERICA-02 (ET26-082)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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