An interventional study of Physical activity recommendations and Physical Activity (PA) Intervention in Lung Neoplasms and Non Small Cell Lung Cancer, sponsored by Centre Leon Berard. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Centre Leon Berard · Not applicable, Interventional, and Supportive care
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.
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)
Exclusion Criteria:
Behavioral: Physical activity recommendations
Behavioral: Physical activity recommendations · Behavioral: Physical Activity (PA) Intervention
At the baseline, all participants will receive the international recommendations in terms of physical activity for promoting health in the general population.
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.
Evaluate the effect of a structured exercise program on immune pathological response (irPR)
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.
Time frame: T2 (pre-surgery):
Evaluate changes in the tumor immune microenvironment
Assessment of stromal CD8+ CTL density, plasma cells (CD138/MUM1), mature tertiary lymphoid structures (CD20/CD23), and CTL/Treg (FOXP3) ratio.
Time frame: Mainly pre surgery (T2), compared with baseline biopsy collected at inclusion (T1).
Objective Response Rate (ORR)
Evaluate tumor response to neoadjuvant treatment.
Time frame: From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
Pathological Complete Response (pCR)
Assess the absence of viable tumor cells in the surgical specimen.
Time frame: T2 (surgery)
Major Pathological Response (MPR)
Evaluate residual tumor burden following neoadjuvant therapy.
Time frame: T2 (surgery).
Disease-Free Survival (DFS)
Evaluate recurrence-free survival following treatment.
Time frame: T3 (6 weeks post-surgery) and T4 (3 months post-surgery).
Treatment-Related Toxicities
Incidence, nature, and severity of adverse events according to CTCAE v5.0.
Time frame: During the first, second, and third cycles of neoadjuvant chemotherapy ( Each cycle is separated by 21 days).
Postoperative Complications
Incidence and severity of postoperative complications according to Clavien-Dindo classification.
Time frame: T3 (6 weeks post-surgery).
Length of Postoperative Hospital Stay
Number of hospital days following surgery.
Time frame: Assessed 6 weeks after surgery (T3)
90-Day Postoperative Mortality
Mortality occurring within 90 days after surgery.
Time frame: T4 (3 months post-surgery).
Change in Aerobic Capacity
Measurement of submaximal oxygen consumption.
Time frame: at study inclusion and at the pre-surgery visit.
Change in Peripheral Muscle Strength
Assessment of quadriceps isometric strength and core endurance (plank test).
Time frame: at study inclusion and at the pre-surgery visit.
Change in Functional Capacity
Six-Minute Walk Test (6MWT) and handgrip strength.
Time frame: at study inclusion and at the pre-surgery visit.
Change in Functionnal capacity
Handgrip test strength.
Time frame: at study inclusion and at the pre-surgery visit.
Change in Lean and Fat Mass
Body composition analysis using (CT-scan) imaging at the L3 vertebral level and bioimpedance assessment
Time frame: at study inclusion and at the pre-surgery visit.
Level of physical activity
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.
Time frame: at study inclusion and at the pre-surgery visit.
Change in Quality of Life
Evaluation using EORTC QLQ-F17
Time frame: at study inclusion and at the pre-surgery visit.
Change of quality of life
Evaluation using EORTC QLQ-LC13 questionnaires.
Time frame: at study inclusion and at the pre-surgery visit.
Change in Cancer-Related Fatigue
Assessment using the FACT-Fatigue questionnaire.
Time frame: at study inclusion and at the pre-surgery visit.
Change in Circulating Immune and Inflammatory Biomarkers
Analysis of cytokines and myeloid/lymphoid cell populations using flow cytometry and MSD technology.
Time frame: At study inclusion, during the second cycle of neoadjuvant chemotherapy(Each cycle is separated by 21 days) and before surgery
Participation Rate
Proportion of eligible patients enrolled in the study.
Time frame: At screening and 6 months
Exercise Program Adherence
Exercise adherence measured as the percentage of prescribed exercise sessions completed. Values range from 0% to 100%, with higher percentages indicating greater 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
Attrition Rate
Proportion of participants withdrawing from the study.
Time frame: 6 months
Program Acceptability and Satisfaction
Participant satisfaction with the exercise intervention, assessed using a self-administered questionnaire developed specifically for this study
Time frame: pre-surgery (T2) : intervention arm only
Ancillary - Characterize Exercise-Induced Changes in the Tumor Immune Microenvironment
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™).
Time frame: Comparison of tumor samples collected at baseline from the pre-treatment biopsy and at surgery
Plan to share: No
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Centre Leon Berard