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 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Manon GOUEZ, Phd
- Telefonnummer: 0033451304860
- E-post: manon.gouez@lyon.unicancer.fr
Studera Kontakt Backup
- Namn: Meyssane Djebali, Msc
- Telefonnummer: 003426556743
- E-post: meyssane.djebali@lyon.unicancer.fr
Studieorter
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Villefranche-sur-Saône, Frankrike
- Hopitaux Nord Ouest
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Underutredare:
- Camille SIMON
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Kontakt:
- HUET
- Telefonnummer: +33 474092385
- E-post: ahuet@hno.fr
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Underutredare:
- Luc Odier
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Underutredare:
- Christine Dussopt
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Underutredare:
- Lionel Falchero
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Rhône
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Lyon, Rhône, Frankrike, 69373
- Centre Léon Berard (CLB)
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Huvudutredare:
- Aurelie Swalduz, MD
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Kontakt:
- Aurelie Swalduz
- Telefonnummer: +33 4069856217
- E-post: aurelie.swalduz@lyon.unicancer.fr
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Physical Activity Recommendations
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Vid baslinjen kommer alla deltagare att få de internationella rekommendationerna när det gäller fysisk aktivitet för att främja hälsa i allmänheten.
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Experimentell: Supervised Physical Activity Program
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Vid baslinjen kommer alla deltagare att få de internationella rekommendationerna när det gäller fysisk aktivitet för att främja hälsa i allmänheten.
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluate the effect of a structured exercise program on immune pathological response (irPR)
Tidsram: 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):
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Evaluate changes in the tumor immune microenvironment
Tidsram: 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)
Tidsram: From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
|
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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Ancillary - Characterize Exercise-Induced Changes in the Tumor Immune Microenvironment
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 juli 2026
Primärt slutförande (Beräknad)
30 juni 2029
Avslutad studie (Beräknad)
31 december 2029
Studieregistreringsdatum
Först inskickad
10 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
25 augusti 2026
Första postat (Faktisk)
26 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 augusti 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Luftvägssjukdomar
- Lungsjukdomar
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Beteende
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Motorisk aktivitet
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Undersökningstekniker
- Utöva
- Metoder
Andra studie-ID-nummer
- ERICA-02 (ET26-082)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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