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)
2026年8月25日 更新者：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.
調査の概要
状態
状態
まだ募集していません
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
介入
入学 (推定)
入学
40
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Manon GOUEZ, Phd
- 電話番号：0033451304860
- メール：manon.gouez@lyon.unicancer.fr
研究連絡先のバックアップ
- 名前：Meyssane Djebali, Msc
- 電話番号：003426556743
- メール：meyssane.djebali@lyon.unicancer.fr
研究場所
-
-
-
Villefranche-sur-Saône、フランス
- Hopitaux Nord Ouest
-
副調査官：
- Camille SIMON
-
コンタクト：
- HUET
- 電話番号：+33 474092385
- メール：ahuet@hno.fr
-
副調査官：
- Luc Odier
-
副調査官：
- Christine Dussopt
-
副調査官：
- Lionel Falchero
-
-
Rhône
-
Lyon、Rhône、フランス、69373
- Centre Léon Berard (CLB)
-
主任研究者：
- Aurelie Swalduz, MD
-
コンタクト：
- Aurelie Swalduz
- 電話番号：+33 4069856217
- メール：aurelie.swalduz@lyon.unicancer.fr
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ：Physical Activity Recommendations
|
ベースラインでは、すべての参加者は、一般集団の健康を促進するための身体活動に関する国際的な推奨事項を受け取ります。
|
|
実験的：Supervised Physical Activity Program
|
ベースラインでは、すべての参加者は、一般集団の健康を促進するための身体活動に関する国際的な推奨事項を受け取ります。
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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluate the effect of a structured exercise program on immune pathological response (irPR)
時間枠：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.
|
T2 (pre-surgery):
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluate changes in the tumor immune microenvironment
時間枠：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.
|
Mainly pre surgery (T2), compared with baseline biopsy collected at inclusion (T1).
|
|
Objective Response Rate (ORR)
時間枠：From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
|
Evaluate tumor response to neoadjuvant treatment.
|
From study inclusion until completion of the 3 planned neoadjuvant chemotherapy cycles, prior to surgery
|
|
Pathological Complete Response (pCR)
時間枠：T2 (surgery)
|
Assess the absence of viable tumor cells in the surgical specimen.
|
T2 (surgery)
|
|
Major Pathological Response (MPR)
時間枠：T2 (surgery).
|
Evaluate residual tumor burden following neoadjuvant therapy.
|
T2 (surgery).
|
|
Disease-Free Survival (DFS)
時間枠：T3 (6 weeks post-surgery) and T4 (3 months post-surgery).
|
Evaluate recurrence-free survival following treatment.
|
T3 (6 weeks post-surgery) and T4 (3 months post-surgery).
|
|
Treatment-Related Toxicities
時間枠：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.
|
During the first, second, and third cycles of neoadjuvant chemotherapy ( Each cycle is separated by 21 days).
|
|
Postoperative Complications
時間枠：T3 (6 weeks post-surgery).
|
Incidence and severity of postoperative complications according to Clavien-Dindo classification.
|
T3 (6 weeks post-surgery).
|
|
Length of Postoperative Hospital Stay
時間枠：Assessed 6 weeks after surgery (T3)
|
Number of hospital days following surgery.
|
Assessed 6 weeks after surgery (T3)
|
|
90-Day Postoperative Mortality
時間枠：T4 (3 months post-surgery).
|
Mortality occurring within 90 days after surgery.
|
T4 (3 months post-surgery).
|
|
Change in Aerobic Capacity
時間枠：at study inclusion and at the pre-surgery visit.
|
Measurement of submaximal oxygen consumption.
|
at study inclusion and at the pre-surgery visit.
|
|
Change in Peripheral Muscle Strength
時間枠：at study inclusion and at the pre-surgery visit.
|
Assessment of quadriceps isometric strength and core endurance (plank test).
|
at study inclusion and at the pre-surgery visit.
|
|
Change in Functional Capacity
時間枠：at study inclusion and at the pre-surgery visit.
|
Six-Minute Walk Test (6MWT) and handgrip strength.
|
at study inclusion and at the pre-surgery visit.
|
|
Change in Functionnal capacity
時間枠：at study inclusion and at the pre-surgery visit.
|
Handgrip test strength.
|
at study inclusion and at the pre-surgery visit.
|
|
Change in Lean and Fat Mass
時間枠：at study inclusion and at the pre-surgery visit.
|
Body composition analysis using (CT-scan) imaging at the L3 vertebral level and bioimpedance assessment
|
at study inclusion and at the pre-surgery visit.
|
|
Level of physical activity
時間枠：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.
|
at study inclusion and at the pre-surgery visit.
|
|
Change in Quality of Life
時間枠：at study inclusion and at the pre-surgery visit.
|
Evaluation using EORTC QLQ-F17
|
at study inclusion and at the pre-surgery visit.
|
|
Change of quality of life
時間枠：at study inclusion and at the pre-surgery visit.
|
Evaluation using EORTC QLQ-LC13 questionnaires.
|
at study inclusion and at the pre-surgery visit.
|
|
Change in Cancer-Related Fatigue
時間枠：at study inclusion and at the pre-surgery visit.
|
Assessment using the FACT-Fatigue questionnaire.
|
at study inclusion and at the pre-surgery visit.
|
|
Change in Circulating Immune and Inflammatory Biomarkers
時間枠：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.
|
At study inclusion, during the second cycle of neoadjuvant chemotherapy(Each cycle is separated by 21 days) and before surgery
|
|
Participation Rate
時間枠：At screening and 6 months
|
Proportion of eligible patients enrolled in the study.
|
At screening and 6 months
|
|
Exercise Program Adherence
時間枠：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.
|
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
時間枠：6 months
|
Proportion of participants withdrawing from the study.
|
6 months
|
|
Program Acceptability and Satisfaction
時間枠：pre-surgery (T2) : intervention arm only
|
Participant satisfaction with the exercise intervention, assessed using a self-administered questionnaire developed specifically for this study
|
pre-surgery (T2) : intervention arm only
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ancillary - Characterize Exercise-Induced Changes in the Tumor Immune Microenvironment
時間枠：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™).
|
Comparison of tumor samples collected at baseline from the pre-treatment biopsy and at surgery
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
研究開始
2026年7月30日
一次修了 (推定)
一次修了
2029年6月30日
研究の完了 (推定)
研究の完了
2029年12月31日
試験登録日
最初に提出
最初に提出
2026年8月10日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年8月25日
最初の投稿 (実際)
最初の投稿
2026年8月26日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年8月26日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年8月25日
最終確認日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- ERICA-02 (ET26-082)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。