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NCT Number: NCT07786909

ERICA-02 Study : Impact of Physical Exercise on the Tumor Immune Microenvironment in Patients Treated With Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cancer

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.

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Key information

Conditions

Lung Neoplasms Behavior Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Motor Activity Neoplasms Neoplasms by Site Non Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Berard (CLB), Lyon, Rhône, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity recommendations

Behavioral

At the baseline, all participants will receive the international recommendations in terms of physical activity for promoting health in the general population.

Physical Activity (PA) Intervention

Behavioral

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.

Primary outcomes

  1. Evaluate the effect of a structured exercise program on immune pathological response (irPR)

    Time frame: 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.

Secondary outcomes

  1. Evaluate changes in the tumor immune microenvironment

    Time frame: 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.

  2. Objective Response Rate (ORR)

    Time frame: From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery

    Evaluate tumor response to neoadjuvant treatment.

  3. Pathological Complete Response (pCR)

    Time frame: T2 (surgery)

    Assess the absence of viable tumor cells in the surgical specimen.

  4. Major Pathological Response (MPR)

    Time frame: T2 (surgery).

    Evaluate residual tumor burden following neoadjuvant therapy.

  5. Disease-Free Survival (DFS)

    Time frame: T3 (6 weeks post-surgery) and T4 (3 months post-surgery).

    Evaluate recurrence-free survival following treatment.

  6. Treatment-Related Toxicities

    Time frame: 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.

  7. Postoperative Complications

    Time frame: T3 (6 weeks post-surgery).

    Incidence and severity of postoperative complications according to Clavien-Dindo classification.

  8. Length of Postoperative Hospital Stay

    Time frame: Assessed 6 weeks after surgery (T3)

    Number of hospital days following surgery.

  9. 90-Day Postoperative Mortality

    Time frame: T4 (3 months post-surgery).

    Mortality occurring within 90 days after surgery.

  10. Change in Aerobic Capacity

    Time frame: at study inclusion and at the pre-surgery visit.

    Measurement of submaximal oxygen consumption.

  11. Change in Peripheral Muscle Strength

    Time frame: at study inclusion and at the pre-surgery visit.

    Assessment of quadriceps isometric strength and core endurance (plank test).

  12. Change in Functional Capacity

    Time frame: at study inclusion and at the pre-surgery visit.

    Six-Minute Walk Test (6MWT) and handgrip strength.

  13. Change in Functionnal capacity

    Time frame: at study inclusion and at the pre-surgery visit.

    Handgrip test strength.

  14. Change in Lean and Fat Mass

    Time frame: at study inclusion and at the pre-surgery visit.

    Body composition analysis using (CT-scan) imaging at the L3 vertebral level and bioimpedance assessment

  15. Level of physical activity

    Time frame: 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.

  16. Change in Quality of Life

    Time frame: at study inclusion and at the pre-surgery visit.

    Evaluation using EORTC QLQ-F17

  17. Change of quality of life

    Time frame: at study inclusion and at the pre-surgery visit.

    Evaluation using EORTC QLQ-LC13 questionnaires.

  18. Change in Cancer-Related Fatigue

    Time frame: at study inclusion and at the pre-surgery visit.

    Assessment using the FACT-Fatigue questionnaire.

  19. Change in Circulating Immune and Inflammatory Biomarkers

    Time frame: 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.

  20. Participation Rate

    Time frame: At screening and 6 months

    Proportion of eligible patients enrolled in the study.

  21. Exercise Program Adherence

    Time frame: 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.

  22. Attrition Rate

    Time frame: 6 months

    Proportion of participants withdrawing from the study.

  23. Program Acceptability and Satisfaction

    Time frame: pre-surgery (T2) : intervention arm only

    Participant satisfaction with the exercise intervention, assessed using a self-administered questionnaire developed specifically for this study

Other outcomes

  1. Ancillary - Characterize Exercise-Induced Changes in the Tumor Immune Microenvironment

    Time frame: 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™).

Study contacts

Contact information is provided by the study sponsor or research team.

Manon GOUEZ, Phd

CONTACT

[email protected]

0033451304860

Meyssane Djebali, Msc

CONTACT

[email protected]

003426556743

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Acronym: ERICA-02

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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