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一项对表皮生长因子受体 (EGFR) 外显子 20 插入的晚期非小细胞肺癌患者进行 Zipalertinib 联合化疗与单独化疗比较的研究。 (REZILIENT3)

2026年10月30日 更新者：Taiho Oncology, Inc.

随机、对照、开放标签、3 期、全球多中心试验，旨在评估 Zipalertinib 加化疗与单独化疗对既往未经治疗的局部晚期或转移性非鳞状非小细胞肺癌 (NSCLC) 患者的疗效和安全性具有表皮生长因子受体 (EGFR) 外显子 20 插入 (ex20ins) 突变

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

This study will evaluate the efficacy and safety of zipalertinib in combination with standard chemotherapy with pemetrexed and a platinum agent (either carboplatin or cisplatin) in patients with previously untreated, locally advanced or metastatic nonsquamous NSCLC harboring EGFR ex20ins mutations.

The study will be conducted in two parts:

  • Part A: Safety lead-in to determine the recommended dose of zipalertinib in combination with standard chemotherapy pemetrexed and a platinum agent (either carboplatin or cisplatin) to be studied in Part B of the study.
  • Part B: Randomized, controlled, open-label, multinational Phase 3 study to assess the efficacy and safety of zipalertinib in combination with standard chemotherapy with pemetrexed and a platinum agent (either carboplatin or cisplatin) compared to standard chemotherapy alone. Patients randomized to the chemotherapy-only treatment arm in Part B may receive treatment with zipalertinib as monotherapy after BICR-assessed progressive disease (PD) is documented (optional "crossover arm").

An independent data monitoring committee (IDMC) will be established to monitor interim safety Data.

A treatment cycle is defined as 21 days for both parts of the study.

Part A: Safety Lead-In The primary objective of Part A is to determine the recommended dose of zipalertinib administered in combination with pemetrexed and a platinum agent (either carboplatin or cisplatin) to be studied in the Phase 3 portion of this study.

Approximately 6-12 patients will receive zipalertinib administered at an initial dose of zipalertinib PO BID (Dose Level 1) in combination with pemetrexed and carboplatin or cisplatin on a 21-day cycle. Patients may continue to receive study treatment until documentation of progressive disease (PD) or until other withdrawal criteria are met, whichever comes first. Patients will be enrolled using a rolling-6 design,35 and the determination of the dose of zipalertinib to be used in Part B of the study will be informed by the incidence of dose-limiting toxicities (DLTs) observed during Cycle 1.

Part B: Phase 3 Enrollment into the Phase 3 portion of the study will begin following completion of Part A.

Approximately 260 patients will be randomized on a 1:1 basis to receive pemetrexed and a platinum agent (either carboplatin or cisplatin) with or without zipalertinib on a 21-day cycle.

Carboplatin or cisplatin will be administered for 4 cycles. Patients may continue to receive zipalertinib (experimental study arm) and pemetrexed (both study arms) until documentation of PD or until other withdrawal criteria are met, whichever comes first.

研究类型

介入性

注册 (实际的)

285

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 以色列
      • Afula、以色列、18101
        • Emek Medical Center
      • Jerusalem、以色列、9103102
        • Shaare Zedek Medical Center
      • Tel Aviv、以色列、69710
        • Assuta Hospital - Ramat HaHayal
  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 4E6
        • BC Cancer Vancouver
    • Ontario
      • Brampton、Ontario、加拿大、L6R 3J7
        • William Osler Health System - Brampton Civic Hospital
      • Toronto、Ontario、加拿大、M5G 2M9
        • Princess Margaret Cancer Centre
  • 土耳其（türkiye）
      • Adana、土耳其（türkiye）、01120
        • Medical Park Seyhan Hastanesi
      • Ankara、土耳其（türkiye）、6520
        • Memorial Ankara Hastanesi
      • Ankara、土耳其（türkiye）、06010
        • Hacettepe Üniversitesi Kanser Enstitüsü
      • Edirne、土耳其（türkiye）、22130
        • Trakya Üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi
      • Etlik、土耳其（türkiye）、06010
        • Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi
      • Istanbul、土耳其（türkiye）、34214
        • Bagcilar Medipol Mega Universite Hastanesi
      • Istanbul、土耳其（türkiye）、34722
        • T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
      • Çankaya、土耳其（türkiye）、06800
        • T.C. Saglik Bakanligi Ankara Bilkent Sehi?r Hastanesi?
  • 墨西哥
      • Aguascalientes、墨西哥、20124
        • Investigacion Medica Galerias
      • Veracruz、墨西哥、91900
        • FAICIC Clínical Research
    • Jalisco
      • Guadalajara、Jalisco、墨西哥、44280
        • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
      • Guadalajara、Jalisco、墨西哥、44680
        • Actualidad Basada en la Investigación del Cáncer
    • Mexico City
      • Mexico City、Mexico City、墨西哥、3100
        • Health Pharma Professional Research S.A. De C.V
    • Puebla
      • Mirador、Puebla、墨西哥、72530
        • Clínica Integral Internacional de Oncología S de RL de CV
  • 巴西
    • Ceará
      • Fortaleza、Ceará、巴西、60335-480
        • Centro Regional Integrado de Oncologia
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90110-270
        • Hospital Mãe de Deus - Centro Integrado de Oncologia
      • Porto Alegre、Rio Grande do Sul、巴西、90610-000
        • Hospital São Lucas da PUCRS
    • Santa Catatina
      • Itajaí、Santa Catatina、巴西、88301
        • Clínica Neoplasias Litoral
    • São Paulo
      • Jaú、São Paulo、巴西、17210-180
        • Hospital Amaral Carvalho
  • 希腊
    • Attica
      • Athens、Attica、希腊、11527
        • General Hospital for Thoracic Diseases Sotiria
  • 德国
      • München、德国、80337
        • LMU Klinikum - Campus Innenstadt
      • Regensburg、德国、93053
        • Universitätsklinikum Regensburg
    • Hesse
      • Giessen、Hesse、德国、35392
        • Universitätsklinikum Gießen und Marburg - Gießen
  • 意大利
      • Milan、意大利、20132
        • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
      • Modena、意大利、41224
        • Azienda Ospedaliero - Universitaria di Modena
      • Pavia、意大利、27100
        • Fondazione IRCCS Policlinico San Matteo
      • Ravenna、意大利、48121
        • Azienda Unità Sanitaria Locale della Romagna
      • Roma、意大利、1444
        • IRCCS Istituto Nazionale Tumori Regina Elena
      • Verona、意大利、37126
        • Azienda Ospedaliera Universitaria Integrata Verona
    • Forli-Cesena
      • Meldola、Forli-Cesena、意大利、47014
        • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
    • Forlì-Cesena
      • Meldola、Forlì-Cesena、意大利、47014
        • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
    • Genoa
      • Genova、Genoa、意大利、16132
        • Istituto Nazionale per la Ricerca sul Cancro
  • 新加坡
      • Singapore、新加坡、168583
        • National Cancer Centre Singapore
      • Singapore、新加坡、228510
        • Icon Cancer Centre - Mount Alvernia
      • Singapore、新加坡、30433
        • Tan Tock Seng Hospital
      • Singapore、新加坡、574623
        • Icon Cancer Centre Mount Elizabeth
      • Singapore、新加坡、308900
        • Oncocare Cancer Centre
  • 日本
      • Kanazawa、日本、920-8641
        • Kanazawa University Hospital
      • Osaka、日本、534-0021
        • Osaka City General Hospital
      • Osaka、日本、541-8567
        • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
    • Aiti [Aichi]
      • Nagoya、Aiti [Aichi]、日本、464-8681
        • Aichi Cancer Center
    • Aomori
      • Hirosaki-Shi、Aomori、日本、036-8563
        • Hirosaki University Hospital
    • Hukuoka
      • Fukuoka、Hukuoka、日本、811-1395
        • Kyushu Cancer Center
    • Kanagawa
      • Sagamihara、Kanagawa、日本、252-0375
        • Kitasato University Hospital
    • Kumamoto
      • Kumamoto、Kumamoto、日本、861-4163
        • Saiseikai Kumamoto Hospital
    • Miyagi
      • Sendai、Miyagi、日本、980-0873
        • Sendai Kousei Hospital
    • Okayama-ken
      • Okayama、Okayama-ken、日本、700-8558
        • Okayama University Hospital
    • Osaka
      • Hirakata、Osaka、日本、573-1191
        • Kansai Medical University Hospital
      • Sakai-Shi、Osaka、日本、591-8555
        • National Hospital Organization Kinki-Chuo Chest Medical Center
    • Tokyo
      • Koto、Tokyo、日本、135-8550
        • Cancer Institute Hospital of JFCR
      • Shinjuku-Ku、Tokyo、日本、160-8582
        • Keio University Hospital
  • 智利
    • Region de Santiago
      • Santiago、Region de Santiago、智利、7500653
        • CentroEstudiosClinicosSAGA
    • Santiago Metropolitan
      • Independencia、Santiago Metropolitan、智利、8380494
        • Hospital Clínico Universidad de Chile
  • 比利时
    • Flemish Brabant
      • Leuven、Flemish Brabant、比利时、3000
        • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
    • Oost-Vlaaderen
      • Ghent、Oost-Vlaaderen、比利时、9000
        • Algemeen Ziekenhuis Maria Middelares
    • West Flanders
      • Menen、West Flanders、比利时、8930
        • Algemeen Ziekenhuis Delta - Campus Menen
    • West-Vlaanderen
      • Rosières、West-Vlaanderen、比利时、8800
        • Algemeen Ziekenhuis Delta - Campus Rumbeke
  • 法国
      • Quimper、法国、29000
        • CH Cornouaille Quimper
    • Alsace
      • Strasbourg、Alsace、法国、67091
        • Les Hôpitaux Universitaires de Strasbourg
    • Basse-Normandie
      • Caen、Basse-Normandie、法国、14033
        • Hôpital Côte De Nacre
    • Limousin
      • Limoges、Limousin、法国、87042
        • Centre Hospitalier Universitaire Limoges
    • Île-de-France Region
      • Boulogne-Billancourt、Île-de-France Region、法国、92100
        • Hôpital Ambroise-Paré
      • Paris、Île-de-France Region、法国、75248
        • Institut Curie
  • 波兰
    • Greater Poland Voivodeship
      • Pozna?、Greater Poland Voivodeship、波兰、60-569
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
    • Lublin Voivodeship
      • Lublin、Lublin Voivodeship、波兰、20-954
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
    • Lódzkie
      • Lodz、Lódzkie、波兰、90-302
        • Instytut MSF
  • 泰国
    • Bangkok
      • Bang Phlat、Bangkok、泰国、10700
        • Faculty of Medicine Siriraj Hospital
      • Pathum Wan、Bangkok、泰国、10330
        • King Chulalongkorn Memorial Hospital
    • Khet Dusit
      • Bangkok、Khet Dusit、泰国、10300
        • Navamindradhiraj University - Faculty of Medicine Vajira Hospital
  • 罗马尼亚
      • Suceava、罗马尼亚、720214
        • Clinica SIGMedical
    • Dolj
      • Craiova、Dolj、罗马尼亚、200746
        • Centrul de Oncologie Sf Nectarie
  • 美国
    • Nevada
      • Henderson、Nevada、美国、89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson、Nevada、美国、89074
        • Comprehensive Cancer Centers of Nevada - Southeast Henderson - Stephanie
      • Las Vegas、Nevada、美国、89169
        • Comprehensive Cancer Centers of Nevada - Central Valley - Twain
      • Las Vegas、Nevada、美国、89144
        • Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II
      • Las Vegas、Nevada、美国、89148
        • Comprehensive Cancer Centers of Nevada - Southwest
      • Las Vegas、Nevada、美国、89218
        • Comprehensive Cancer Centers of Nevada - Northwest
    • Ohio
      • Canton、Ohio、美国、44718
        • Gabrail Cancer and Research Center
    • Texas
      • Houston、Texas、美国、77030
        • University of Texas MD Anderson Cancer Center
  • 英国
    • England
      • London、England、英国、NW3 2QG
        • Royal Free London NHS Foundation Trust
      • Nottingham、England、英国、NG5 1PB
        • Nottingham University Hospitals NHS Trust
      • Torquay、England、英国、TQ2 7AA
        • Torbay and South Devon NHS Foundation Trust
  • 荷兰
    • Gelderland
      • Nijmegen、Gelderland、荷兰、6525 GA
        • Radboud Universitair Medisch Centrum
    • North Holland
      • Amsterdam、North Holland、荷兰、1066 CX
        • Antoni Van Leeuwenhoek Ziekenhuis
      • Amsterdam、North Holland、荷兰、1081 HV
        • Vrije Universiteit Medisch Centrum
  • 菲律宾
      • City of Muntinlupa、菲律宾、1780
        • Asian Hospital and Medical Center
    • Metropolitan Manila
      • Quezon City、Metropolitan Manila、菲律宾、1112
        • St. Luke's Medical Center - Quezon City
    • National Capital Region
      • Pasig、National Capital Region、菲律宾、1605
        • The Medical City
  • 西班牙
      • Barcelona、西班牙、08036
        • Hospital Clinic de Barcelona
      • Barcelona、西班牙、08017
        • Clínica Mi Tres Torres
      • Barcelona、西班牙、08023
        • Hospital Quirónsalud Barcelona
      • Jaén、西班牙、23007
        • Hospital Universitario de Jaén
      • Madrid、西班牙、28040
        • Hospital Universitario Fundación Jiménez Díaz
      • Madrid、西班牙、28041
        • Hospital Universitario 12 de Octubre
      • Madrid、西班牙、28046
        • Hospital Universitario La Paz
      • Málaga、西班牙、29010
        • Hospital Regional Universitario de Málaga - Hospital General
    • La Coruña
      • A Coruña、La Coruña、西班牙、15006
        • Complejo Hospitalario Universitario A Coruña
  • 韩国
    • Gyeonggi-do
      • Seongnam-si、Gyeonggi-do、韩国
        • Seoul National University Bundang Hospital
      • Suwon、Gyeonggi-do、韩国、16499
        • Ajou University Hospital
      • Suwon、Gyeonggi-do、韩国、16247
        • Catholic University of Korea Saint Vincent's Hospital
    • Gyeongsangnamdo [Kyongsangnam-do]
      • Jinju、Gyeongsangnamdo [Kyongsangnam-do]、韩国、52727
        • Gyeongsang National University Hospital
    • Incheon Gwang'yeogsi [Inch'on-Kwangyokshi]
      • Incheon、Incheon Gwang'yeogsi [Inch'on-Kwangyokshi]、韩国、22332
        • Inha University Hospital
    • Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
      • Seoul、Seoul Teugbyeolsi [Seoul-T'ukpyolshi]、韩国、02841
        • Korea University Anam Hospital
      • Seoul、Seoul Teugbyeolsi [Seoul-T'ukpyolshi]、韩国、08308
        • Korea University Guro Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion-

  1. Provide written informed consent.

  2. ≥18 years of age (or meets the country's regulatory definition for legal adult age, whichever is greater).

  3. Pathologically confirmed, locally advanced or metastatic nonsquamous NSCLC

  4. Has not received any prior systemic treatment for their locally advanced or metastatic nonsquamous NSCLC. Prior adjuvant/neoadjuvant treatment received >6 months prior to first dose of study treatment is allowed for early-stage

    NSCLC. Prior monotherapy with an approved EGFR TKI (ie, gefitinib, erlotinib, afatinib, dacomitinib, or osimertinib) as nonstandard first-line therapy for the treatment of locally advanced or metastatic disease is allowed if all of the following criteria are met:

    1. Treatment duration did not exceed 8 weeks;
    2. Lack of disease response was documented (radiographically) by an increase in tumor burden (a copy of the computerized tomography [CT] report showing increase in tumor burden from baseline should be submitted);
    3. Associated toxicities have resolved to baseline; and
    4. The EGFR TKI was discontinued at least 2 weeks or 4 half-lives prior to randomization, whichever is longer.

    Prior therapy with EGFR TKI agents targeting exon20ins mutations including amivantamab, mobocertinib, sunvozertinib, furmonertinib, and poziotinib is not allowed.

  5. Documented EGFR mutation status, as determined by local testing performed at a CLIA certified (US) or accredited (outside of the US) local laboratory, defined as follows:

    1. Part A: EGFR ex20ins or other uncommon single or compound EGFR mutation
    2. Part B: EGFR ex20ins mutation

  6. Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFR mutation status and, where possible, other biomarkers. Patients with insufficient tissue (details provided in laboratory manual) may be eligible following discussion with the sponsor; a fresh biopsy will not be required.

  7. Patients with brain metastasis(es) who have previously received definitive local treatment and have stable central nervous system (CNS) disease (defined as being neurologically stable and off corticosteroid for at least 2 weeks prior to enrollment) are eligible. If brain metastases are diagnosed on screening imaging, the patient may be rescreened for eligibility after definitive treatment.

    b. Asymptomatic brain metastases ≤2 cm in size can be eligible for inclusion if, in the opinion of the Investigator, immediate definitive treatment is not indicated.

  8. At least one measurable lesion as determined per RECIST 1.1 for patients enrolling to Part B. Patients enrolling to Part A may be enrolled without measurable disease.

  9. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

  10. Adequate organ function, as defined by the laboratory value

  11. Have a life expectancy of at least 3 months as assessed by the investigator.

  12. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to administration of the first dose of study treatment. Female patients are not considered to be of childbearing potential if they are postmenopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).

  13. Both males and females of reproductive potential must agree to use effective birth control during the study prior to the first dose and for 6 months after the last dose of study treatment or longer, based on local requirements.

Exclusion -

  1. Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study.

  2. Prior treatment with any of the following within the specific time frame specified:

    1. Zipalertinib (TAS6417/CLN-081) at any time.
    2. Thoracic radiotherapy ≤28 days, palliative radiation of nonthoracic disease ≤14 days, or palliative radiation of a single lesion ≤7 days prior to first dose of study treatment.
    3. Major surgery (excluding placement of vascular access) ≤28 days prior to first dose of study treatment.
    4. All prescribed medication, over-the-counter medication, vitamin preparations and other food supplements, or herbal medications that are strong or moderate CYP3A4 inducers or inhibitors within 7 days prior to first dose.

  3. Have any unresolved toxicity of Grade ≥2 from previous anticancer treatment in the neoadjuvant or adjuvant setting, except for Grade 2 alopecia or skin pigmentation. Patients with other chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the investigator and Sponsor.

  4. Past medical history of interstitial lung disease, treatment-related pneumonitis (any grade), or any evidence of clinically active interstitial lung disease.

  5. Impaired cardiac function or clinically significant cardiac disease, including any of the following:

    1. History of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification .
    2. Serious cardiac arrhythmias requiring treatment.
    3. Resting corrected QT interval (QTc) >470 msec calculated using Fridericia's formula (QTcF).

  6. Unable to swallow tablets or has any disease or condition that may significantly affect gastrointestinal (GI) absorption of zipalertinib (such as inflammatory bowel disease, malabsorption syndrome, or prior GI resection).

  7. History of another primary malignancy ≤2 years prior to the date of first dose of study treatment unless at least one of the following criteria are met:

    1. Adequately treated basal or squamous cell carcinoma of the skin
    2. Cancer of the breast or cervix in situ
    3. Previously treated malignancy, if all treatment for that malignancy was completed at least 2 years prior to first dose of study treatment, and no current evidence of disease
    4. Concurrent malignancy determined to be clinically stable and not requiring tumor directed treatment

  8. Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is unstable or not controlled with treatment.

  9. History of COVID-19 infection within 4 weeks prior to enrolment and/or have persistent, clinically significant pulmonary symptoms related to prior COVID-19 infection.

  10. Active bleeding disorders.

  11. Known hypersensitivity to the ingredients in zipalertinib or any drugs similar in structure or class. To platinum-containing drugs (ie, cisplatin, carboplatin), pemetrexed, or any known excipients of these drugs. b. Contraindications toning drugs (ie, cisplatin, carboplatin) or pemetrexed according to the respective local labels.

  12. History of leptomeningeal disease and spinal cord compression.

  13. Is unable or unwilling to take dexamethasone, folic acid, and/or vitamin B12 supplementation during treatment with pemetrexed.

  14. Is pregnant or lactating or planning to become pregnant

  15. The patient is, in the investigator's opinion, unable or unwilling to comply with the trial procedures.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Part A (Safety Lead in)

Part A: Safety Lead-In Approximately 6-12 patients will receive zipalertinib administered at an initial dose of zipalertinib PO BID (Dose Level 1) in combination with pemetrexed and carboplatin or cisplatin on a 21-day cycle. Patients may continue to receive study treatment until documentation of progressive disease (PD) or until other withdrawal criteria are met, whichever comes first.
药品：TAS6417

oral tablets

其他名称：
  • CLN-081
  • 齐帕替尼
实验性的：Part B

Enrollment into the Phase 3 portion of the study will begin following completion of Part A.

Approximately 260 patients will be randomized on a 1:1 basis to receive pemetrexed and a platinum agent (either carboplatin or cisplatin) with or without zipalertinib on a 21-day cycle.

Carboplatin or cisplatin will be administered for 4 cycles. Patients may continue to receive zipalertinib (experimental study arm) and pemetrexed (both study arms) until documentation of PD or until other withdrawal criteria are met, whichever comes first.
药品：TAS6417

oral tablets

其他名称：
  • CLN-081
  • 齐帕替尼

研究衡量的是什么？

主要结果指标

结果测量
大体时间
A 和 B 部分：治疗中出现的 AE 发生率和严重程度
大体时间：约5年
约5年
A 部分和 B 部分：盲法独立中央审查 (BICR) 的无进展生存期 (PFS)
大体时间：约5年
约5年
A 部分：第 1 周期期间根据 NCI 不良事件通用术语标准 (CTCAE) v5.0 的 DLT 发生率和严重程度
大体时间：约5年
约5年

次要结果测量

结果测量
措施说明
大体时间
A 部分和 B 部分：客观缓解率 (ORR)
大体时间：约5年
约5年
A 部分和 B 部分：疾病控制率 (DCR)
大体时间：约5年
约5年
A 部分和 B 部分：响应持续时间 (DoR)
大体时间：约5年
约5年
A 部分和 B 部分：颅内 (i) 总体缓解率 (iORR)
大体时间：约5年
约5年
A 部分和 B 部分：颅内完全缓解持续时间 (iDCR)
大体时间：约5年
约5年
A 部分和 B 部分：颅内反应持续时间 (iDoR)
大体时间：约5年
约5年
B 部分：总生存期 (OS)
大体时间：约5年
约5年
Pharmacokinetic (PK) parameter
大体时间：approximately 5 years

Minimum observed concentration (Cmin)
approximately 5 years
European Quality of Life 5 Dimensions, 3 Level Version (EQ-5D-3L)
大体时间：approximately 5 years

The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. This scale is numbered from 0 to 100. The higher the score the better the outcome
approximately 5 years
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30
大体时间：approximately 5 years

The EORTC QLQ-C30 is a "core questionnaire" which incorporates a range of physical, emotional and social health developed to assess the quality of life of cancer patients. This scale is numbered from 30 to 130. The higher the score equates to better functioning.
approximately 5 years
Non-small Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ )
大体时间：approximately 5 years

The NSCLC- SAQ was developed to incorporate the patient's perspective into evaluation of clinical benefit in advanced non-small cell lung cancer trials.. Qualitative evidence supports 7 items covering 5 symptom concepts with the total score measuring overall severity of the following NSCLC symptoms: cough, pain, dyspnea, fatigue, and appetite. Lower scores indicate lower symptom severity.
approximately 5 years

其他结果措施

结果测量
措施说明
大体时间
Pharmacokinetic (PK) parameter
大体时间：approximately 5 years

Minimum Plasma Concentration [Cmin]
approximately 5 years
Pharmacokinetic (PK) parameter
大体时间：approximately 5 years

Maximum Plasma Concentration [Cmax]
approximately 5 years
Pharmacokinetic (PK) parameter
大体时间：approximately 5 years

Area Under Curve [AUC]
approximately 5 years
EGFR mutation status
大体时间：approximately 5 years

local central tests results
approximately 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Taiho Oncology, Inc.

出版物和有用的链接

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一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年12月18日

初级完成 (估计的)

2027年5月27日

研究完成 (估计的)

2027年5月27日

研究注册日期

首次提交

2023年7月11日

首先提交符合 QC 标准的

2023年7月25日

首次发布 (实际的)

2023年8月3日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月30日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TAS6417-301
  • 2023-503575-21 (EudraCT编号)
  • 2023 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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