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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 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Frankreich
      • Villefranche-sur-Saône, Frankreich
        • Hopitaux Nord Ouest
        • Unterermittler:
          • Camille SIMON
        • Kontakt:
        • Unterermittler:
          • Luc Odier
        • Unterermittler:
          • Christine Dussopt
        • Unterermittler:
          • Lionel Falchero
    • Rhône
      • Lyon, Rhône, Frankreich, 69373

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Physical Activity Recommendations
Verhalten: Empfehlungen für körperliche Aktivität
Als Baseline erhalten alle Teilnehmenden die internationalen Bewegungsempfehlungen zur Förderung der Gesundheit in der Allgemeinbevölkerung.
Experimental: Supervised Physical Activity Program
Verhalten: Empfehlungen für körperliche Aktivität
Als Baseline erhalten alle Teilnehmenden die internationalen Bewegungsempfehlungen zur Förderung der Gesundheit in der Allgemeinbevölkerung.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluate the effect of a structured exercise program on immune pathological response (irPR)
Zeitfenster: 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):

Sekundäre Ergebnismessungen

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

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Ancillary - Characterize Exercise-Induced Changes in the Tumor Immune Microenvironment
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Centre Leon Berard

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. Juli 2026

Primärer Abschluss (Geschätzt)

30. Juni 2029

Studienabschluss (Geschätzt)

31. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

10. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. August 2026

Zuerst gepostet (Tatsächlich)

26. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. August 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ERICA-02 (ET26-082)

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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