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)
2026년 8월 25일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
40
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Manon GOUEZ, Phd
- 전화번호: 0033451304860
- 이메일: manon.gouez@lyon.unicancer.fr
연구 연락처 백업
- 이름: Meyssane Djebali, Msc
- 전화번호: 003426556743
- 이메일: meyssane.djebali@lyon.unicancer.fr
연구 장소
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Villefranche-sur-Saône, 프랑스
- Hopitaux Nord Ouest
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부수사관:
- Camille SIMON
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연락하다:
- HUET
- 전화번호: +33 474092385
- 이메일: ahuet@hno.fr
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부수사관:
- Luc Odier
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부수사관:
- Christine Dussopt
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부수사관:
- Lionel Falchero
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Rhône
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Lyon, Rhône, 프랑스, 69373
- Centre Léon Berard (CLB)
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수석 연구원:
- Aurelie Swalduz, MD
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연락하다:
- Aurelie Swalduz
- 전화번호: +33 4069856217
- 이메일: aurelie.swalduz@lyon.unicancer.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Physical Activity Recommendations
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기준선에서 모든 참가자는 일반 인구의 건강 증진을 위한 신체 활동 측면에서 국제 권장 사항을 받게 됩니다.
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실험적: Supervised Physical Activity Program
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기준선에서 모든 참가자는 일반 인구의 건강 증진을 위한 신체 활동 측면에서 국제 권장 사항을 받게 됩니다.
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Evaluate the effect of a structured exercise program on immune pathological response (irPR)
기간: 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):
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Evaluate changes in the tumor immune microenvironment
기간: 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)
기간: From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
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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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Ancillary - Characterize Exercise-Induced Changes in the Tumor Immune Microenvironment
기간: 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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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 7월 30일
기본 완료 (추정된)
기본 완료
2029년 6월 30일
연구 완료 (추정된)
연구 완료
2029년 12월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 10일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 25일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 26일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 25일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- ERICA-02 (ET26-082)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .