治療歴のあるステージ IV 非扁平上皮非小細胞肺がん (NSCLC) の参加者における治験薬の研究 (MK-3475-01H/KEYMAKER-U01)
KEYMAKER-U01 サブスタディ 01H: 治療歴のあるステージ IV 非扁平上皮非小細胞肺がん (NSCLC) の参加者を対象に、治験薬のローリングアームを使用した第 2 相ランダム化包括的研究
Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs.
Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing.
However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells.
Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn:
- About the safety of the study treatments and if people tolerate them
- How many people have the cancer respond to the study treatments
調査の概要
状態
条件
詳細な説明
The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Toll Free Number
- 電話番号：1-888-577-8839
- メール：Trialsites@msd.com
研究場所
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Kentucky
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Lexington、Kentucky、アメリカ、40536-0293
- 募集
- University of Kentucky Chandler Medical Center ( Site 0019)
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コンタクト：
- Study Coordinator
- 電話番号：859-257-1000
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Maryland
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Baltimore、Maryland、アメリカ、21237
- 募集
- MedStar Franklin Square Medical Center ( Site 0033)
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コンタクト：
- Study Coordinator
- 電話番号：443-777-7147
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15212
- 募集
- AHN Cancer Institute - Allegheny General ( Site 9501)
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コンタクト：
- Study Coordinator
- 電話番号：412-325-5700
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Texas
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Dallas、Texas、アメリカ、75246-2046
- 募集
- Texas Oncology - DFW ( Site 8003)
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コンタクト：
- Study Coordinator
- 電話番号：214-370-1067
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Haifa、イスラエル、3109601
- 募集
- Rambam Health Care Campus ( Site 0076)
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コンタクト：
- Study Coordinator
- 電話番号：+972-4-7776234
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Jerusalem、イスラエル、9103102
- 募集
- Shaare Zedek Medical Center ( Site 0075)
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コンタクト：
- Study Coordinator
- 電話番号：+972-2-6555768
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Kfar Saba、イスラエル、4428164
- 募集
- Meir Medical Center ( Site 0071)
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コンタクト：
- Study Coordinator
- 電話番号：+97297472414
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Petah Tikva、イスラエル、4941492
- 募集
- Rabin Medical Center ( Site 0074)
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コンタクト：
- Study Coordinator
- 電話番号：+97239378101
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Ramat Gan、イスラエル、5265601
- 募集
- Sheba Medical Center ( Site 0070)
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コンタクト：
- Study Coordinator
- 電話番号：+97235307032
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Tel Aviv、イスラエル、6423906
- 募集
- Sourasky Medical Center ( Site 0077)
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コンタクト：
- Study Coordinator
- 電話番号：+972-3-6973082
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Florence、イタリア、50134
- 募集
- Azienda Ospedaliera Universitaria Careggi ( Site 0173)
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コンタクト：
- Study Coordinator
- 電話番号：+393209225506
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Milan、イタリア、20132
- 募集
- Ospedale San Raffaele. ( Site 0171)
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コンタクト：
- Study Coordinator
- 電話番号：+390223903829
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Roma、イタリア、00168
- 募集
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
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コンタクト：
- Study Coordinator
- 電話番号：+390630156318
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Lombardy
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Milan、Lombardy、イタリア、20133
- 募集
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
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コンタクト：
- Study Coordinator
- 電話番号：390223902190
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Thessaloniki、ギリシャ、570 01
- 募集
- European Interbalkan Medical Center ( Site 0205)
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コンタクト：
- Study Coordinator
- 電話番号：0030 2310400213
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Attica
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Athens、Attica、ギリシャ、115 27
- 募集
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204)
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コンタクト：
- Study Coordinator
- 電話番号：0030 2107700220
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Madrid、スペイン、28223
- 募集
- Hospital Universitario Quiron Madrid ( Site 0091)
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コンタクト：
- Study Coordinator
- 電話番号：34914521987
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Barcelona
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L'Hospitalet de Llobregat、Barcelona、スペイン、08908
- 募集
- Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
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コンタクト：
- Study Coordinator
- 電話番号：0034932607744
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Region M. de Santiago
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Santiago、Region M. de Santiago、チリ、7500653
- 募集
- Centro de Estudios Clínicos SAGA ( Site 0161)
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コンタクト：
- Study Coordinator
- 電話番号：+5690556961
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Santiago、Region M. de Santiago、チリ、8420383
- 募集
- Bradfordhill ( Site 0162)
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コンタクト：
- Study Coordinator
- 電話番号：+56229490970
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Santiago、Region M. de Santiago、チリ、7500921
- 募集
- Fundación Arturo López Pérez ( Site 0160)
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コンタクト：
- Study Coordinator
- 電話番号：56227128000
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Adana、トルコ（Türkiye）、01250
- 募集
- Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)
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コンタクト：
- Study Coordinator
- 電話番号：+90 322 344 44 44
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Ankara、トルコ（Türkiye）、06230
- 募集
- Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
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コンタクト：
- Study Coordinator
- 電話番号：+90 312 305 43 36
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Ankara、トルコ（Türkiye）、06800
- 募集
- Ankara Bilkent Şehir Hastanesi. ( Site 0142)
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コンタクト：
- Study Coordinator
- 電話番号：+905555306271
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Istanbul、トルコ（Türkiye）、34098
- 募集
- I. U. Cerrahpasa Tip Fakultesi ( Site 0144)
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コンタクト：
- Study Coordinator
- 電話番号：+902124143000
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Izmir、トルコ（Türkiye）、35100
- 募集
- Ege Universitesi Hastanesi ( Site 0143)
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コンタクト：
- Study Coordinator
- 電話番号：+90 232 343 43 43
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Berlin、ドイツ、13353
- 募集
- Charite-Universitaetsmedizin Berlin ( Site 0191)
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コンタクト：
- Study Coordinator
- 電話番号：+49 30 450 553 044
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Baden-Wurttemberg
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Tübingen、Baden-Wurttemberg、ドイツ、72076
- 募集
- Universitaetsklinik Tuebingen ( Site 0192)
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コンタクト：
- Study Coordinator
- 電話番号：+4970712982795
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Bács-Kiskun county
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Kecskemét、Bács-Kiskun county、ハンガリー、6000
- 募集
- Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
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コンタクト：
- Study Coordinator
- 電話番号：+3676516700
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Győr-Moson-Sopron
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Győr、Győr-Moson-Sopron、ハンガリー、9024
- 募集
- Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
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コンタクト：
- Study Coordinator
- 電話番号：+3696507900
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Jász-Nagykun-Szolnok
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Szolnok、Jász-Nagykun-Szolnok、ハンガリー、5000
- 募集
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)
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コンタクト：
- Study Coordinator
- 電話番号：+3656503603
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Pest County
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Törökbálint、Pest County、ハンガリー、2045
- 募集
- Református Pulmonológiai Centrum ( Site 0064)
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コンタクト：
- Study Coordinator
- 電話番号：+3623511570
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Greater Poland Voivodeship
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Poznan、Greater Poland Voivodeship、ポーランド、60-569
- 募集
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)
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コンタクト：
- Study Coordinator
- 電話番号：+48616654242
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Masovian Voivodeship
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Warsaw、Masovian Voivodeship、ポーランド、02-781
- 募集
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
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コンタクト：
- Study Coordinator
- 電話番号：+48225463066
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Pomeranian Voivodeship
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Gdansk、Pomeranian Voivodeship、ポーランド、80-214
- 募集
- Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
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コンタクト：
- Study Coordinator
- 電話番号：+48585844466
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West Pomeranian Voivodeship
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Koszalin、West Pomeranian Voivodeship、ポーランド、75-581
- 積極的、募集していない
- Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
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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
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of Stage IV nonsquamous non-small cell lung cancer (NSCLC)
- Documented disease progression per RECIST 1.1 after receiving an anti-programmed cell death 1 protein (PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy
- Confirmation per local test report that epidermal growth factor receptor negative (EGFR-), anaplastic lymphoma kinase negative (ALK-), c ros oncogene 1 negative (ROS1-), or other directed therapy is not indicated as primary therapy
- Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR
- Life expectancy of at least 3 months
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- Is an individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent
- Has adequate organ function
- If capable of producing sperm refrains from donating sperm plus either abstains from penile-vaginal intercourse or uses a penile/external condom, with contraceptive use consistent with local regulations
- Participant/participants of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test; and is not breastfeeding and uses a highly effective contraceptive method
- Archival tumor tissue sample of a tumor lesion not previously irradiated has been provided
- Has provided tissue prior to treatment randomization from a newly obtained formalin-fixed sample from a new biopsy
- Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Received radiation therapy to the lung
- Has uncontrolled or significant cardiovascular disorder prior to randomization
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
- Has known severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
- Has clinically significant corneal disease
- Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
- Has inadequate washout period prior to randomization
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has previously received docetaxel as monotherapy or in combination with other therapies
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has evidence of any leptomeningeal disease
- Has history of interstitial lung disease (ILD)/pneumonitis, current diagnosis of ILD, and/or suspected ILD
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has active infection requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- Has known history of, or active, neurologic paraneoplastic syndrome
- Has history of allogeneic tissue/solid organ transplant
- Have not adequately recovered from major surgery or have ongoing surgical complications
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Raludotatug Deruxtecan
Participants receive raludotatug deruxtecan (R-DXd) 5.6 mg/kg via intravenous (IV) Infusion every 3 weeks (q3w) until disease progression or discontinuation criterion is met. |
IV Infusion
他の名前：
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
他の名前：
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
他の名前：
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration |
|
実験的：Ifinatamab Deruxtecan
Participants receive ifinatamab deruxtecan (I-DXd) 12 mg/kg via IV infusion q3w until disease progression or discontinuation criterion is met. |
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
他の名前：
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
他の名前：
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration IV Infusion
他の名前：
|
|
アクティブコンパレータ：Docetetaxel
Participants receive docetaxel 75mg/m2 via IV infusion q3w until disease progression or discontinuation criterion is met. |
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration IV Infusion |
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 |
|---|---|---|
|
Objective Response Rate (ORR)
時間枠：Up to approximately 81 months
|
ORR is defined as the percentage of participants with Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. |
Up to approximately 81 months
|
|
Percentage of Participants with at Least One Adverse Event (AE)
時間枠：Up to approximately 81 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who experience an AE will be reported. |
Up to approximately 81 months
|
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Percentage of Participants Who Discontinued Medication Due to an AE
時間枠：Up to approximately 24 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who discontinue study intervention due to an AE will be reported. |
Up to approximately 24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Duration of Response (DOR)
時間枠：Up to approximately 81 months
|
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. |
Up to approximately 81 months
|
|
Progression-free Survival (PFS)
時間枠：Up to approximately 81 months
|
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. |
Up to approximately 81 months
|
|
Overall Survival (OS)
時間枠：Up to approximately 81 months
|
OS is defined as the time from randomization to death due to any cause. |
Up to approximately 81 months
|
協力者と研究者
スポンサー
協力者
捜査官
- スタディディレクター：Medical Director、Merck Sharp & Dohme LLC
出版物と役立つリンク
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
追加の関連 MeSH 用語
その他の研究ID番号
- 3475-01H
- KEYMAKER-U01 (その他の識別子：MSD)
- MK-3475-01H (その他の識別子：MSD)
- U1111-1314-1785 (レジストリ識別子：UTN)
- 2024-518761-10-00 (レジストリ識別子：EU CT)
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
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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。