Immunological Markers Predictive of Response and Toxicity to Checkpoint Inhibitors in Non-small Cell Lung Cancer (IMMUNO-PREDICT)
Immunological Markers Predictive of Response and Toxicity to Checkpoint in Metastatic Non-Small-cell Lung Cancers
調査の概要
状態
条件
詳細な説明
The study will run for 12 months with a 6-month follow-up at the inclusion of the last patient.
Patients will be included from the initiation of immunotherapy treatment regardless of the line.The routine immunological workup will be performed before the first immunotherapy infusion in order to analyze a certain number of immunological markers (autoantibodies, RF, LDH, complement (C3 C4), anti-tissue antibodies, lymphocyte immunophenotyping). This assessment will then be performed at progression, at the appearance of side effects requiring the immunotherapy to be stopped, or at 6 months of follow-up in case of continuation of the immunotherapy.
The investigators will evaluate the response to the treatment, the progression via re-evaluation assessments performed in standard practice (every 3 to 4 courses depending on the type of immunotherapy) as well as the appearance of side effects throughout the follow-up will be evaluate.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Gilles QUERE
- 電話番号：0298223740
- メール：gilles.quere@chu-brest.fr
研究連絡先のバックアップ
- 名前：Renaud Descourt
- メール：renaud.descourt@chu-brest.fr
研究場所
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Brest、フランス、29609
- 募集
- CHRU de Brest
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コンタクト：
- Gilles QUERE
- メール：gilles.quere@chu-brest.fr
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Major patient
- Metastatic non-small cell lung cancer
- Initiation of anti PDL1 therapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUAMB) in daily practice
- No objection made
Exclusion Criteria:
- Autoimmune disease diagnosed prior to initiation of immune checkpoint inhibitor therapy.
- Previous immune-modulating therapy (including corticosteroid therapy greater than 10 mg/day)
- Patient with prior checkpoint inhibitor therapy
- Patient with a contraindication to immunotherapy
- Patient under legal protection
- Refusal to participate
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change of biological markers of immunity under immunotherapy at 6 months
時間枠：Day 0 and month 6 (M6)
|
Determine the proportion of patients who have or will develop a change in biological markers of immunity under immunotherapy at 6 months or, failing that, at the end of the immunotherapy (FAN and/or RF and/or anti-tissue and/or decrease in acquired complement verified on the difference between 6 months and inclusion, lymphocyte immunophenotyping)
|
Day 0 and month 6 (M6)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Impact on Overall Survival (OS) and Progression Free Survival (PFS)
時間枠：Day 0 and Six month after (M6)
|
Determine if the presence of biological markers of autoimmunity at initiation or during anti-PD1/PDL1 immunotherapy influences overall survival or progression-free survival.
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Day 0 and Six month after (M6)
|
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Impact on autoimmune toxicity
時間枠：Day 0 and month 6 (M6)
|
Determine if the presence of biological markers of autoimmunity (at inclusion, at 6 months or at progression) is associated with autoimmune toxicity (any clinical or biological autoimmune event regardless of its grade). Determine if the presence of biological markers of autoimmunity (at inclusion, at 6 months or at progression) is associated with autoimmune toxicity (any clinical or biological autoimmune event regardless of its grade). |
Day 0 and month 6 (M6)
|
|
Impact of complement
時間枠：Day 0 and month 6 (M6)
|
Determine if the decrease in complement at 6 months is associated with autoimmune toxicity.
|
Day 0 and month 6 (M6)
|
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Impact of autoimmune toxicity on OS
時間枠：Day 0 and month 6 (M6)
|
Determine if the occurrence of autoimmune toxicity during anti-PD1/PDL1 immunotherapy for non-small cell lung cancer influences the patient's overall survival.
|
Day 0 and month 6 (M6)
|
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Impact of autoimmune toxicity on PFS
時間枠：Day 0 and month 6 (M6)
|
Determine if the occurrence of autoimmune toxicity during anti-PD1/PDL1 immunotherapy for non-small cell lung cancer influences the patient's progression-free survival.
|
Day 0 and month 6 (M6)
|
|
Impact of clinical factors
時間枠：Day 0 and month 6 (M6)
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Determine if clinical factors (undernutrition, tumor mass, general condition) at initiation or during anti-PD1/PDL1 immunotherapy influence patient's overall survival and progression-free survival
|
Day 0 and month 6 (M6)
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Study the clinical factors influencing the immune profile
時間枠：Day 0 and month 6 (M6)
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Study the clinical factors influencing the immune profile
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Day 0 and month 6 (M6)
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Impact of CRP and lymphopenia
時間枠：Day 0 and month 6 (M6)
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Determine if CRP and the presence of initial lymphopenia influence the presence or induction of an immunological abnormality
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Day 0 and month 6 (M6)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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
米国FDA規制機器製品の研究
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。
肺癌の臨床試験
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