手術可能な非小細胞肺がん（NSCLC）の成人患者を対象とした、セミプリマブ＋化学療法とセミプリマブ＋化学療法＋その他のがん治療の研究
切除可能な非小細胞肺がん患者の周術期治療におけるセミプリマブと化学療法と他のがん治療を比較するためのランダム化第 2 相プラットフォーム研究
This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer (NSCLC) for whom surgery is planned, in the resectable NSCLC portion.
The aim of the resectable NSCLC portion is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.
For each investigational arm, the available data will be reviewed to decide whether safety testing with chemotherapy is needed before moving the treatment combination to the main resectable NSCLC portion of the study. If safety testing with chemotherapy is required, adult participants whose tumour has spread to other organs or cannot be removed by surgery, will be enrolled in the unresectable/metastatic NSCLC portion of the study called the "safety lead-in."
The aim of the unresectable/metastatic NSCLC safety lead-in portion is to evaluate the safety of the combination of Cemiplimab, chemotherapy, and an additional drug in participants with unresectable or metastatic NSCLC.
For the resectable NSCLC portion, the study is also looking at several other research questions, including:
- What are the side effects associated with the investigational treatments in comparison to the control treatment
- Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed
- How much of the study drug(s) are in the blood at a given time
- Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)
For the unresectable/metastatic NSCLC portion, the study is also looking at several other research questions, including:
- What are the side effects associated with the additional drug in combination with cemiplimab and chemotherapy
- How does the additional drug work in combination with cemiplimab and chemotherapy
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
California
-
Orange、California、アメリカ、92868
- University of California Irvine
-
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Illinois
-
Skokie、Illinois、アメリカ、60077
- Orchard Healthcare Research Inc.
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-
Michigan
-
Detroit、Michigan、アメリカ、48201
- Karmanos Cancer Institute
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Farmington Hills、Michigan、アメリカ、48334
- Detroit Clinical Research Center
-
-
Ohio
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Cincinnati、Ohio、アメリカ、45245
- Oncology Hematology Care Clinical Trials LLC
-
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Oregon
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Portland、Oregon、アメリカ、97213
- Providence Portland Medical Center
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Portland、Oregon、アメリカ、97213
- University Of Nebraska Medical Center
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-
Rhode Island
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Providence、Rhode Island、アメリカ、02903
- Lifespan Cancer Institute
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South Dakota
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Watertown、South Dakota、アメリカ、57201
- Prairie Lakes Healthcare System
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Tennessee
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Knoxville、Tennessee、アメリカ、37920
- University of Tennessee Medical Center
-
Nashville、Tennessee、アメリカ、37203
- Sarah Cannon Research Institute (SCRI) Oncology Partners
-
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Virginia
-
Blacksburg、Virginia、アメリカ、24060
- BRCC/Oncology & Hematology Associates of SW Virginia
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-
-
-
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Madrid、スペイン、28046
- Hospital Universitario La Paz
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Madrid、スペイン、28040
- Hospital Universitario Clinico San Carlos
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Madrid、スペイン、28033
- MD Anderson Cancer Center
-
Madrid、スペイン、28050
- Hospital Universitario HM Sanchinarro
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Seville、スペイン、41013
- Hospital Virgen del Rocio
-
Valencia、スペイン、46014
- Consorci Hospital General Universitario de Valencia
-
Valencia、スペイン、46010
- Hospital Clinico Universitario Valencia
-
Zaragoza、スペイン、50009
- Hospital Clinico Lozano Blesa
-
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Barcelona
-
Badalona、Barcelona、スペイン、08916
- Catalan Instituye of Oncology Badalona
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Cantabria
-
Santander、Cantabria、スペイン、39008
- Hospital Valdecilla
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Las Palmas
-
Las Palmas de Gran Canaria、Las Palmas、スペイン、35016
- Hospital Universitario Insular de Gran Canaria
-
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Navarre
-
Pamplona、Navarre、スペイン、31008
- Clinica Universidad de Navarra
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-
-
-
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Istanbul、トルコ（Türkiye）、34295
- Florya Medical Park Hospital
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-
-
-
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Aachen、ドイツ、52074
- University Hospital RWTH Aachen
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Hesse
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Kassel、Hesse、ドイツ、34125
- Klinikum Kassel GmbH, Hauttumorzentrum
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Lower Saxony
-
Göttingen、Lower Saxony、ドイツ、37083
- University Medicine Gottingen
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Saxony
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Leipzig、Saxony、ドイツ、04103
- University of Leipzig
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-
-
-
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Bayonne、フランス、64100
- Clinique Belharra
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Bayonne、フランス、64100
- Centre Hospitalier de la Cote Basque
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Grenoble、フランス、38330
- CHU Grenoble Alpes
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Montpellier、フランス、34295
- Montpellier Academic Hospital
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Brittany Region
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Rennes、Brittany Region、フランス、35033
- CHU Rennes
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Var
-
Toulon、Var、フランス、83055
- Centre Hospitalier Intercommunal Toulon - CHITS
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Île-de-France Region
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Paris、Île-de-France Region、フランス、75005
- Institut Curie
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-
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São Paulo、ブラジル、01323-903
- Hospital Alemao Oswaldo Cruz
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Espírito Santo
-
Cachoeiro de Itapemirim、Espírito Santo、ブラジル、29306014
- Oncology Clinical Research Center
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Minas Gerais
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Belo Horizonte、Minas Gerais、ブラジル、30380-472
- Instituto Mario Penna
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Pouso Alegre、Minas Gerais、ブラジル、37554-238
- Instituto Sul Mineiro De Oncologia LTDA
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Pernambuco
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Recife、Pernambuco、ブラジル、50070-902
- Instituto de Medicina Integral Professor Fernando Figueira
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Rio Grande do Norte
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Natal、Rio Grande do Norte、ブラジル、59060-195
- Liga Norte Riograndense Contra o Cancer
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、ブラジル、90610-000
- Hospital Sao Lucas da PUCRS
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Porto Alegre、Rio Grande do Sul、ブラジル、90110-270
- Hospital Mae de Deus Integrated Oncology Center
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Santa Catarina
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Florianópolis、Santa Catarina、ブラジル、88020-210
- Ynova Pesquisa Clinica
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São Paulo
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Sorocaba、São Paulo、ブラジル、18065-100
- Unimed Sorocaba
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São José do Rio Preto、São Paulo、ブラジル、15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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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
説明
Neoadjuvant Resectable NSCLC General Key Inclusion Criteria:
- Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
- Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
- Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
- Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
- Adequate organ and bone marrow function, as described in the protocol
Arm Specific Inclusion Criteria:
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:
- Non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC
- Availability of an archival or on-trial FFPE tumor tissue sample
- ECOG performance status of 0 or 1
- Per investigator judgment, life expectancy of at least 3 months
Neoadjuvant Resectable NSCLC General Key Exclusion Criteria:
- Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
- Presence of actionable oncogenic alterations in the tumor for which an approved targeted therapy is available or for which perioperative chemoimmunotherapy is not considered an appropriate standard of care treatment, as described in the protocol
- Presence of grade≥ 2 peripheral neuropathy
- Another malignancy that is progressing or requires active treatment, as described in the protocol
Arm Specific Exclusion Criteria:
Neoadjuvant Resectable NSCLC - Arm 1:
- Grade ≥3 hypercalcemia, as defined in the protocol
- Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
- Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:
- Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
- Presence of actionable oncogenic alterations in the tumor for which a chemotherapy plus programmed cell death protein 1 (PD1) inhibitor backbone is not the appropriate initial therapy as standard of care
- Known allergy or hypersensitivity to any components of trial interventions
- Any condition requiring ongoing/continuous corticosteroid therapy, as described in the protocol
Neoadjuvant Resectable NSCLC - Arm 2:
1. History of encephalitis, meningitis, organic brain disease, or uncontrolled seizures within 1 year prior to the first dose of trial interventions.
Note: Other protocol-defined Inclusion/Exclusion criteria apply.
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
- 主な目的：処理
- 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）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Neoadjuvant Resectable NSCLC - Control Arm
|
Administered per the protocol
他の名前：
Administered per the protocol |
|
実験的：Neoadjuvant Resectable NSCLC - Arm 1
|
Administered per the protocol
他の名前：
Administered per the protocol
他の名前：
Administered per the protocol |
|
実験的：Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
|
Administered per the protocol
他の名前：
Administered per the protocol Administered per the protocol
他の名前：
|
|
実験的：Neoadjuvant Resectable NSCLC - Arm 2
|
Administered per the protocol
他の名前：
Administered per the protocol Administered per the protocol
他の名前：
|
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 |
|---|---|---|
|
Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR)
時間枠：Up to 12 weeks
|
Up to 12 weeks
|
|
|
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
時間枠：Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of TEAEs leading to death
時間枠：Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of TEAEs leading to treatment discontinuation
時間枠：Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of Serious Adverse Events (SAEs)
時間枠：Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
|
Occurrence of grade ≥3 laboratory abnormalities
時間枠：Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades) |
Up to 9 weeks
|
|
Number of participants unable to receive cemiplimab and chemotherapy for 2 consecutive cycles due to REGN10597-related toxicities during the first 3 cycles
時間枠：Up to 9 weeks
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 9 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
全生存期間 (OS)
時間枠：5年まで
|
5年まで
|
|
|
TEAEの重症度
時間枠：最長76週間
|
最長76週間
|
|
|
TEAEによる手術遅延の割合
時間枠：最長76週間
|
最長76週間
|
|
|
TEAEによりキャンセルされた手術の割合
時間枠：最長76週間
|
最長76週間
|
|
|
Pathologic Complete Response (pCR) rate as determined by central BIPR
時間枠：Up to 12 weeks
|
Up to 12 weeks
|
|
|
Residual Viable Tumor (RVT) as determined by central BIPR
時間枠：Up to 12 weeks
|
Up to 12 weeks
|
|
|
Event-Free Survival (EFS)
時間枠：Up to 5 years
|
Up to 5 years
|
|
|
Objective Response by investigator assessment
時間枠：Up to 9 weeks
|
Up to 9 weeks
|
|
|
Duration of Response (DoR) by investigator assessment
時間枠：Up to 2 years
|
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2 |
Up to 2 years
|
|
Occurrence of TEAEs
時間枠：Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of TEAEs leading to death
時間枠：Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of TEAEs leading to treatment discontinuation
時間枠：Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of SAEs
時間枠：Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of SAEs
時間枠：Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of Adverse Events of Special Interest (AESIs)
時間枠：Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of AESIs
時間枠：Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of immune-mediated Adverse Events (imAEs)
時間枠：Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of imAEs
時間枠：Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of Infusion-Related Reactions (IRRs)
時間枠：Up to 76 weeks
|
Up to 76 weeks
|
|
|
Severity of IRRs
時間枠：Up to 76 weeks
|
Up to 76 weeks
|
|
|
Occurrence of grade ≥3 laboratory abnormalities
時間枠：Up to 76 weeks
|
As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades) |
Up to 76 weeks
|
|
Occurrence of Anti-Drug Antibodies (ADAs) to cemiplimab
時間枠：Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to cemiplimab
時間枠：Up to 67 weeks
|
Up to 67 weeks
|
|
|
Occurrence of ADAs to marlotamig
時間枠：Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to marlotamig
時間枠：Up to 67 weeks
|
Up to 67 weeks
|
|
|
Occurrence of ADAs to REGN10597
時間枠：Up to 67 weeks
|
Up to 67 weeks
|
|
|
Magnitude of ADAs to REGN10597
時間枠：Up to 67 weeks
|
Up to 67 weeks
|
協力者と研究者
捜査官
- スタディディレクター：Clinical Trial Management、Regeneron Pharmaceuticals
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
その他の研究ID番号
- R2810-ONC-2268
- 2023 (米国 NIH グラント/契約)
- 2023-509806-31-00 (Ctis)
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
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD 共有時間枠
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD 共有アクセス基準
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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。