転移性非小細胞肺がんの参加者におけるアミバンタマブとセトレリマブの併用療法の研究 (PolyDamas)
転移性非小細胞肺がんにおけるアミバンタマブとセトレリマブの併用療法の安全性と有効性を評価する第 1/2 相試験
The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and cetrelimab combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection); and to evaluate the antitumor effect of the combination at the selected RP2CD in participants with NSCLC characterized on the basis of epidermal growth factor receptor (EGFR) and Programmed-cell death Ligand (PD-L)1 status, in the Phase 2 (expansion).
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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California
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Duarte、California、アメリカ、91010
- City of Hope
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Irvine、California、アメリカ、92618
- City of Hope Orange County Lennar Foundation Cancer Center
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Los Alamitos、California、アメリカ、90720
- Cancer and Blood Specialty Clinic
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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、97225
- Providence Oncology and Hematology Care Clinic Westside
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Texas
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Houston、Texas、アメリカ、77030
- MD Anderson Cancer Center
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Virginia
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Fairfax、Virginia、アメリカ、22031
- Virginia Cancer Specialists
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London、イギリス、W6 8RF
- Imperial College London and Imperial College Healthcare NHS Trust
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Newcastle、イギリス、NE7 7DN
- Freeman Hospital
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Sutton、イギリス、SM2 5PT
- Royal Marsden Hospital
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Milan、イタリア、20162
- ASST Grande Ospedale Metropolitano Niguarda
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Milan、イタリア、20141
- European Institute of Oncology
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Orbassano、イタリア、10043
- Aou San Luigi Gonzaga
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Verona、イタリア、37134
- Centro Ricerche Cliniche di Verona S r l
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Alicante、スペイン、03010
- Hosp. Gral. Univ. de Alicante
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Barcelona、スペイン、8028
- Hosp. Univ. Quiron Dexeus
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Barcelona、スペイン、08035
- Hosp Univ Vall D Hebron
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Madrid、スペイン、28041
- Hosp. Univ. 12 de Octubre
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Seville、スペイン、41009
- Hosp. Virgen Macarena
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Valencia、スペイン、46009
- Instituto Valenciano de Oncologia
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Adana、トルコ（Türkiye）、01170
- Adana City Hospital
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Ankara、トルコ（Türkiye）、06800
- Ankara Bilkent Sehir Hastanesi
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Ankara、トルコ（Türkiye）、06200
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
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Ankara、トルコ（Türkiye）、06800
- Ankara Bilkent Sehir Hastanesi 1
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Istanbul、トルコ（Türkiye）、34147
- Bakirkoy Sadi Konuk Training and Research Hospital
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Istanbul、トルコ（Türkiye）、34722
- Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
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Izmir、トルコ（Türkiye）、35170
- Medicana International Izmir
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Sakarya、トルコ（Türkiye）、54100
- Sakarya Universitesi Egitim Ve Arastırma Hastanesi
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Barretos、ブラジル、14784 400
- Fundacao Pio XII
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Belo Horizonte、ブラジル、30110 022
- Cetus Oncologia
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Belo Horizonte、ブラジル、30130 090
- PERSONAL Oncologia de Precisao e Personalizada
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Curitiba、ブラジル、80810 050
- CIONC Centro Integrado de Oncologia de Curitiba
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Londrina、ブラジル、86015 520
- Hospital do Cancer de Londrina
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Porto Alegre、ブラジル、91350 200
- Hospital Nossa Senhora da Conceicao S A
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Salvador、ブラジル、40050-410
- Hospital Santa Izabel Santa Casa de Misericordia da Bahia
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São Paulo、ブラジル、01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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Lublin、ポーランド、20 609
- INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o
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Poznan、ポーランド、60 569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
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Warsaw、ポーランド、02 781
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Kuala Lumpur、マレーシア、59100
- University Malaya Medical Centre
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Kuching、マレーシア、93586
- Hospital Umum Sarawak
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Seoul、韓国、03080
- Seoul National University Hospital
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Seoul、韓国、03722
- Severance Hospital Yonsei University Health System
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Seoul、韓国、06351
- Samsung Medical Center
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参加基準
適格基準
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
Inclusion Criteria:
- Participant must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) (any histology), and must have metastatic NSCLC at the time of enrollment: Phase 1 (Combination Dose Selection) Cohort; Metastatic NSCLC progressed on or after standard of care systemic anti-cancer therapy and participant is declining other systemic treatment options, if any;1. Participants without known mutations must have had disease progression on, or have intolerance to, prior platinum-based chemotherapy and PD-(L)1-targeted immunotherapy given concurrently or sequentially, OR 2. Participants with NSCLC characterized by known driver mutations must have had disease progression on, or have intolerance to, appropriate targeted therapies as per local standard of care. Participants may have received prior therapy with amivantamab as long as discontinuation was not due to toxicity. Participants with EGFR mutation must not have had an anti-PD-1/PD-L1 therapy, Phase 2 Expansion Cohorts; Cohort A: Participant's tumor must have an EGFR exon19del or L858R mutation, as determined by local molecular testing, Cohort B: Participants must have tumors lacking known primary driver mutations and must have PD-L1 expression of greater than or equal to (>=)50 percentage (%), per local testing, and are treatment-naïve in the metastatic setting
- Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, that has not been previously irradiated
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Participant has an uncontrolled illness, including but not limited to: a. Uncontrolled diabetes, b. Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting study treatment] or diagnosed or suspected viral infection), c. Active bleeding diathesis, d. Impaired oxygenation requiring continuous oxygen supplementation, e. Psychiatric illness or any other circumstances (including social circumstances) that would limit compliance with study requirements
- Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Has an active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents
- Participant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatment
- Participant has a. (or has a history of) leptomeningeal disease (carcinomatous meningitis), b. spinal cord compression not definitively treated with surgery or radiation
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：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
アーム数
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 |
|---|---|
|
実験的：Phase 1 (Combination Dose Selection)
Participants will receive amivantamab low dose or high dose intravenous (IV) infusion based on body weight from Cycle 1 Day 1, Day 2, and subsequently Day 8, Day 15, and Day 22 and then every 2 weeks from Cycle 2 in combination with cetrelimab IV infusion from Cycle 1 Day 2 (after the Day 2 infusion of amivantamab). Cetrelimab treatment duration will be limited to a maximum of 24 months. Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined by the study evaluation team (SET). Participants who continue to benefit from study treatment(s), as determined by their investigator, may continue to receive access to study treatment(s) within the study by transferring to a long term extension (LTE) phase. |
Amivantamab will be administered as IV infusion.
他の名前：
Cetrelimab will be administered as IV infusion.
他の名前：
|
|
実験的：Phase 2 (Dose Expansion)
Participants will receive amivantamab in combination with cetrelimab in Cohorts A and B at the RP2CD determined by the SET in Phase 1. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met. Cetrelimab treatment duration will be limited to a maximum of 24 months. Participants who continue to benefit from study treatment(s), as determined by their investigator, may continue to receive access to study treatment(s) within the study by transferring to an LTE phase. |
Amivantamab will be administered as IV infusion.
他の名前：
Cetrelimab will be administered as IV infusion.
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
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 1: Number of Participants with Adverse events (AEs) by Severity
時間枠：Up to 2 years 3 months
|
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Up to 2 years 3 months
|
|
Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)
時間枠：Up to Cycle 1 (Day 1 through Day 28)
|
The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, hematological toxicity, pulmonary toxicity, liver enzyme elevation, treatment delay greater than (>) 28 days due to unresolved toxicity, or immune-related toxicity requiring the use of therapies in excess of corticosteroids. |
Up to Cycle 1 (Day 1 through Day 28)
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Phase 2: Objective Response Rate
時間枠：Up to 2 years 3 months
|
ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as per investigator assessment. |
Up to 2 years 3 months
|
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 |
|---|---|---|
|
Phase 1 and Phase 2: Number of Participants with AEs by Severity
時間枠：Up to 2 years 3 months
|
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Up to 2 years 3 months
|
|
Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters
時間枠：Up to 2 years 3 months
|
Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported. |
Up to 2 years 3 months
|
|
Phase 2 : Duration of Response (DoR)
時間枠：Up to 2 years 3 months
|
DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participants who have PR or CR. If a participant does not progress following a response, then his/her duration of response will be censored at the date of last evaluable disease assessment. Participants who started a subsequent anticancer therapy in the absence of progression will be censored at the last disease assessment before or on the start of subsequent therapy. |
Up to 2 years 3 months
|
|
Phase 2: Disease Control Rate (DCR)
時間枠：Up to 2 years 3 months
|
DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1 by investigator review. |
Up to 2 years 3 months
|
|
Phase 2: Progression Free Survival (PFS)
時間枠：Up to 2 years 3 months
|
PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1. Participants who have not progressed or have not died at the time of analysis will be censored at the time of their last evaluable RECIST v1.1 assessment. |
Up to 2 years 3 months
|
|
Phase 2: Overall Survival (OS)
時間枠：Up to 2 years 3 months
|
OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause. Any participant not known to have died at the time of analysis will be censored based on the last recorded date on which the participant was known to be alive. |
Up to 2 years 3 months
|
協力者と研究者
捜査官
捜査官
- スタディディレクター：Janssen Research & Development, LLC Clinical trial、Janssen Research & Development, LLC
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
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
最初の投稿 (実際)
最初の投稿
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
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
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- CR109323
- 61186372PANSC2002 (その他の識別子：Janssen Research & Development, LLC)
- 2022-501452-29-00 (レジストリ識別子：EUCT number)
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
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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。