Lung NeoplasmsERICA-02NCT07786909
ERICA-02 Study : Impact of Physical Exercise on the Tumor Immune Microenvironment in Patients Treated With Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cancer
A study testing Physical activity recommendations and Physical Activity (PA) Intervention in people with Lung Neoplasms and Non Small Cell Lung Cancer, run by Centre Leon Berard at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Non Small Cell Lung Cancer
- What is being tested?
- Physical activity recommendations and Physical Activity (PA) Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Oct 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Léon Berard (CLB)
Lyon, Rhône, 69373
Aurelie Swalduz, 4069856217 ext. +33, aurelie.swalduz@lyon.unicancer.fr
Aurelie Swalduz, MD
- Recruiting
Hopitaux Nord Ouest
Villefranche-sur-Saône
HUET, 474092385 ext. +33, ahuet@hno.fr
Luc Odier
About this study
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.
- Conditions
- Lung Neoplasms, Non Small Cell Lung Cancer
- Being tested
- Physical activity recommendations, Physical Activity (PA) Intervention
- Keywords
- physical Activity
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity recommendationsBehavioural
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) InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Recommendations | Active comparator | Not described Receives: Behavioral: Physical activity recommendations |
| Supervised Physical Activity Program | Experimental | Not described Receives: Behavioral: Physical activity recommendations; Behavioral: Physical Activity (PA) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T2 (pre-surgery):
Secondary outcomes (23)
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.
Measured: Mainly pre surgery (T2), compared with baseline biopsy collected at inclusion (T1).
Objective Response Rate (ORR)
Evaluate tumor response to neoadjuvant treatment.
Measured: 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.
Measured: T2 (surgery)
Major Pathological Response (MPR)
Evaluate residual tumor burden following neoadjuvant therapy.
Measured: T2 (surgery).
Disease-Free Survival (DFS)
Evaluate recurrence-free survival following treatment.
Measured: 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.
Measured: 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.
Measured: T3 (6 weeks post-surgery).
Length of Postoperative Hospital Stay
Number of hospital days following surgery.
Measured: Assessed 6 weeks after surgery (T3)
90-Day Postoperative Mortality
Mortality occurring within 90 days after surgery.
Measured: T4 (3 months post-surgery).
Change in Aerobic Capacity
Measurement of submaximal oxygen consumption.
Measured: at study inclusion and at the pre-surgery visit.
Change in Peripheral Muscle Strength
Assessment of quadriceps isometric strength and core endurance (plank test).
Measured: at study inclusion and at the pre-surgery visit.
Change in Functional Capacity
Six-Minute Walk Test (6MWT) and handgrip strength.
Measured: at study inclusion and at the pre-surgery visit.
Change in Functionnal capacity
Handgrip test strength.
Measured: 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
Measured: 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.
Measured: at study inclusion and at the pre-surgery visit.
Change in Quality of Life
Evaluation using EORTC QLQ-F17
Measured: at study inclusion and at the pre-surgery visit.
Change of quality of life
Evaluation using EORTC QLQ-LC13 questionnaires.
Measured: at study inclusion and at the pre-surgery visit.
Change in Cancer-Related Fatigue
Assessment using the FACT-Fatigue questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Program Acceptability and Satisfaction
Participant satisfaction with the exercise intervention, assessed using a self-administered questionnaire developed specifically for this study
Measured: pre-surgery (T2) : intervention arm only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start29 Oct 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786909
- Sponsor's protocol ID
- ERICA-02 (ET26-082)
- Acronym
- ERICA-02
- Status last verified
- Nov 2026
- First submitted
- 10 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERICA-02 Study : Impact of Physical Exercise on the Tumor Immune Microenvironment in Patients Treated With Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07786909
- Acronym / sponsor ID
- ERICA-02 / ERICA-02 (ET26-082)
- Conditions
- Lung Neoplasms, Non Small Cell Lung Cancer
- Keywords
- physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 29 Oct 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Recommendations | Active comparator | Behavioral: Physical activity recommendations |
| Supervised Physical Activity Program | Experimental | Behavioral: Physical activity recommendations, Behavioral: Physical Activity (PA) Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity recommendationsAt the baseline, all participants will receive the international recommendations in terms of physical activity for promoting health in the general population. | Behavioural | Physical Activity Recommendations, Supervised Physical Activity Program |
| Physical Activity (PA) InterventionThe 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. | Behavioural | Supervised Physical Activity Program |
Primary outcome
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.
23 secondary outcomes
Evaluate changes in the tumor immune microenvironment
Time frame: Mainly pre surgery (T2), compared with baseline biopsy collected at inclusion (T1).
Objective Response Rate (ORR)
Time frame: From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
Pathological Complete Response (pCR)
Time frame: T2 (surgery)
Major Pathological Response (MPR)
Time frame: T2 (surgery).
Disease-Free Survival (DFS)
Time frame: T3 (6 weeks post-surgery) and T4 (3 months post-surgery).
Treatment-Related Toxicities
Time frame: During the first, second, and third cycles of neoadjuvant chemotherapy ( Each cycle is separated by 21 days).
Postoperative Complications
Time frame: T3 (6 weeks post-surgery).
Length of Postoperative Hospital Stay
Time frame: Assessed 6 weeks after surgery (T3)
90-Day Postoperative Mortality
Time frame: T4 (3 months post-surgery).
Change in Aerobic Capacity
Time frame: at study inclusion and at the pre-surgery visit.
Change in Peripheral Muscle Strength
Time frame: at study inclusion and at the pre-surgery visit.
Change in Functional Capacity
Time frame: at study inclusion and at the pre-surgery visit.
Change in Functionnal capacity
Time frame: at study inclusion and at the pre-surgery visit.
Change in Lean and Fat Mass
Time frame: at study inclusion and at the pre-surgery visit.
Level of physical activity
Time frame: at study inclusion and at the pre-surgery visit.
Change in Quality of Life
Time frame: at study inclusion and at the pre-surgery visit.
Change of quality of life
Time frame: at study inclusion and at the pre-surgery visit.
Change in Cancer-Related Fatigue
Time frame: at study inclusion and at the pre-surgery visit.
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
Participation Rate
Time frame: At screening and 6 months
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
Attrition Rate
Time frame: 6 months
Program Acceptability and Satisfaction
Time frame: pre-surgery (T2) : intervention arm only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity recommendations and Physical Activity (PA) Intervention in people with Lung Neoplasms and Non Small Cell Lung Cancer, run by Centre Leon Berard at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon GOUEZ, Phd (0033451304860, manon.gouez@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of a structured exercise program on immune pathological response (irPR) (time frame: T2 (pre-surgery):). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.