표피 성장 인자 수용체(EGFR) 엑손 20 삽입이 있는 진행성 비소세포폐암 환자를 대상으로 한 화학 요법 단독과 비교한 Zipalertinib 및 화학 요법의 연구. (REZILIENT3)
이전에 치료받지 않은 국소 진행성 또는 전이성 비편평 비소세포폐암(NSCLC) 환자에서 지팔러티닙 플러스 화학요법 대 화학요법 단독의 효능 및 안전성을 평가하기 위한 무작위, 통제, 공개 라벨, 3상, 글로벌 다기관 시험 표피 성장 인자 수용체(EGFR) 엑손 20 삽입(ex20ins) 돌연변이
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
-
-
Attica
-
Athens, Attica, 그리스, 11527
- General Hospital for Thoracic Diseases Sotiria
-
-
-
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Gelderland
-
Nijmegen, Gelderland, 네덜란드, 6525 GA
- Radboud Universitair Medisch Centrum
-
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North Holland
-
Amsterdam, North Holland, 네덜란드, 1066 CX
- Antoni Van Leeuwenhoek Ziekenhuis
-
Amsterdam, North Holland, 네덜란드, 1081 HV
- Vrije Universiteit Medisch Centrum
-
-
-
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Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, 대한민국
- Seoul National University Bundang Hospital
-
Suwon, Gyeonggi-do, 대한민국, 16499
- Ajou University Hospital
-
Suwon, Gyeonggi-do, 대한민국, 16247
- Catholic University of Korea Saint Vincent's Hospital
-
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Gyeongsangnamdo [Kyongsangnam-do]
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Jinju, Gyeongsangnamdo [Kyongsangnam-do], 대한민국, 52727
- Gyeongsang National University Hospital
-
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Incheon Gwang'yeogsi [Inch'on-Kwangyokshi]
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Incheon, Incheon Gwang'yeogsi [Inch'on-Kwangyokshi], 대한민국, 22332
- Inha University Hospital
-
-
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
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Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 대한민국, 02841
- Korea University Anam Hospital
-
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 대한민국, 08308
- Korea University Guro Hospital
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-
-
-
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München, 독일, 80337
- LMU Klinikum - Campus Innenstadt
-
Regensburg, 독일, 93053
- Universitätsklinikum Regensburg
-
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Hesse
-
Giessen, Hesse, 독일, 35392
- Universitätsklinikum Gießen und Marburg - Gießen
-
-
-
-
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Suceava, 루마니아, 720214
- Clinica SIGMedical
-
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Dolj
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Craiova, Dolj, 루마니아, 200746
- Centrul de Oncologie Sf Nectarie
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-
-
-
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Aguascalientes, 멕시코, 20124
- Investigacion Medica Galerias
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Veracruz, 멕시코, 91900
- FAICIC Clínical Research
-
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Jalisco
-
Guadalajara, Jalisco, 멕시코, 44280
- Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
-
Guadalajara, Jalisco, 멕시코, 44680
- Actualidad Basada en la Investigación del Cáncer
-
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Mexico City
-
Mexico City, Mexico City, 멕시코, 3100
- Health Pharma Professional Research S.A. De C.V
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Puebla
-
Mirador, Puebla, 멕시코, 72530
- Clínica Integral Internacional de Oncología S de RL de CV
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-
-
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Nevada
-
Henderson, Nevada, 미국, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, 미국, 89074
- Comprehensive Cancer Centers of Nevada - Southeast Henderson - Stephanie
-
Las Vegas, Nevada, 미국, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley - Twain
-
Las Vegas, Nevada, 미국, 89144
- Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II
-
Las Vegas, Nevada, 미국, 89148
- Comprehensive Cancer Centers of Nevada - Southwest
-
Las Vegas, Nevada, 미국, 89218
- Comprehensive Cancer Centers of Nevada - Northwest
-
-
Ohio
-
Canton, Ohio, 미국, 44718
- Gabrail Cancer and Research Center
-
-
Texas
-
Houston, Texas, 미국, 77030
- University of Texas MD Anderson Cancer Center
-
-
-
-
Flemish Brabant
-
Leuven, Flemish Brabant, 벨기에, 3000
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
-
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Oost-Vlaaderen
-
Ghent, Oost-Vlaaderen, 벨기에, 9000
- Algemeen Ziekenhuis Maria Middelares
-
-
West Flanders
-
Menen, West Flanders, 벨기에, 8930
- Algemeen Ziekenhuis Delta - Campus Menen
-
-
West-Vlaanderen
-
Rosières, West-Vlaanderen, 벨기에, 8800
- Algemeen Ziekenhuis Delta - Campus Rumbeke
-
-
-
-
Ceará
-
Fortaleza, Ceará, 브라질, 60335-480
- Centro Regional Integrado de Oncologia
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, 브라질, 90110-270
- Hospital Mãe de Deus - Centro Integrado de Oncologia
-
Porto Alegre, Rio Grande do Sul, 브라질, 90610-000
- Hospital São Lucas da PUCRS
-
-
Santa Catatina
-
Itajaí, Santa Catatina, 브라질, 88301
- Clínica Neoplasias Litoral
-
-
São Paulo
-
Jaú, São Paulo, 브라질, 17210-180
- Hospital Amaral Carvalho
-
-
-
-
-
Barcelona, 스페인, 08036
- Hospital Clinic de Barcelona
-
Barcelona, 스페인, 08017
- Clínica Mi Tres Torres
-
Barcelona, 스페인, 08023
- Hospital Quirónsalud Barcelona
-
Jaén, 스페인, 23007
- Hospital Universitario de Jaén
-
Madrid, 스페인, 28040
- Hospital Universitario Fundación Jiménez Díaz
-
Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, 스페인, 28046
- Hospital Universitario La Paz
-
Málaga, 스페인, 29010
- Hospital Regional Universitario de Málaga - Hospital General
-
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La Coruña
-
A Coruña, La Coruña, 스페인, 15006
- Complejo Hospitalario Universitario A Coruña
-
-
-
-
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Singapore, 싱가포르, 168583
- National Cancer Centre Singapore
-
Singapore, 싱가포르, 228510
- Icon Cancer Centre - Mount Alvernia
-
Singapore, 싱가포르, 30433
- Tan Tock Seng Hospital
-
Singapore, 싱가포르, 574623
- Icon Cancer Centre Mount Elizabeth
-
Singapore, 싱가포르, 308900
- Oncocare Cancer Centre
-
-
-
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England
-
London, England, 영국, NW3 2QG
- Royal Free London NHS Foundation Trust
-
Nottingham, England, 영국, NG5 1PB
- Nottingham University Hospitals NHS Trust
-
Torquay, England, 영국, TQ2 7AA
- Torbay and South Devon NHS Foundation Trust
-
-
-
-
-
Afula, 이스라엘, 18101
- Emek Medical Center
-
Jerusalem, 이스라엘, 9103102
- Shaare Zedek Medical Center
-
Tel Aviv, 이스라엘, 69710
- Assuta Hospital - Ramat HaHayal
-
-
-
-
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Milan, 이탈리아, 20132
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
-
Modena, 이탈리아, 41224
- Azienda Ospedaliero - Universitaria di Modena
-
Pavia, 이탈리아, 27100
- Fondazione IRCCS Policlinico San Matteo
-
Ravenna, 이탈리아, 48121
- Azienda Unità Sanitaria Locale della Romagna
-
Roma, 이탈리아, 1444
- IRCCS Istituto Nazionale Tumori Regina Elena
-
Verona, 이탈리아, 37126
- Azienda Ospedaliera Universitaria Integrata Verona
-
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Forli-Cesena
-
Meldola, Forli-Cesena, 이탈리아, 47014
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
-
-
Forlì-Cesena
-
Meldola, Forlì-Cesena, 이탈리아, 47014
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
-
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Genoa
-
Genova, Genoa, 이탈리아, 16132
- Istituto Nazionale per la Ricerca sul Cancro
-
-
-
-
-
Kanazawa, 일본, 920-8641
- Kanazawa University Hospital
-
Osaka, 일본, 534-0021
- Osaka City General Hospital
-
Osaka, 일본, 541-8567
- Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
-
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Aiti [Aichi]
-
Nagoya, Aiti [Aichi], 일본, 464-8681
- Aichi Cancer Center
-
-
Aomori
-
Hirosaki-Shi, Aomori, 일본, 036-8563
- Hirosaki University Hospital
-
-
Hukuoka
-
Fukuoka, Hukuoka, 일본, 811-1395
- Kyushu Cancer Center
-
-
Kanagawa
-
Sagamihara, Kanagawa, 일본, 252-0375
- Kitasato University Hospital
-
-
Kumamoto
-
Kumamoto, Kumamoto, 일본, 861-4163
- Saiseikai Kumamoto Hospital
-
-
Miyagi
-
Sendai, Miyagi, 일본, 980-0873
- Sendai Kousei Hospital
-
-
Okayama-ken
-
Okayama, Okayama-ken, 일본, 700-8558
- Okayama University Hospital
-
-
Osaka
-
Hirakata, Osaka, 일본, 573-1191
- Kansai Medical University Hospital
-
Sakai-Shi, Osaka, 일본, 591-8555
- National Hospital Organization Kinki-Chuo Chest Medical Center
-
-
Tokyo
-
Koto, Tokyo, 일본, 135-8550
- Cancer Institute Hospital of JFCR
-
Shinjuku-Ku, Tokyo, 일본, 160-8582
- Keio University Hospital
-
-
-
-
Region de Santiago
-
Santiago, Region de Santiago, 칠레, 7500653
- CentroEstudiosClinicosSAGA
-
-
Santiago Metropolitan
-
Independencia, Santiago Metropolitan, 칠레, 8380494
- Hospital Clínico Universidad de Chile
-
-
-
-
British Columbia
-
Vancouver, British Columbia, 캐나다, V5Z 4E6
- BC Cancer Vancouver
-
-
Ontario
-
Brampton, Ontario, 캐나다, L6R 3J7
- William Osler Health System - Brampton Civic Hospital
-
Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Cancer Centre
-
-
-
-
Bangkok
-
Bang Phlat, Bangkok, 태국, 10700
- Faculty of Medicine Siriraj Hospital
-
Pathum Wan, Bangkok, 태국, 10330
- King Chulalongkorn Memorial Hospital
-
-
Khet Dusit
-
Bangkok, Khet Dusit, 태국, 10300
- Navamindradhiraj University - Faculty of Medicine Vajira Hospital
-
-
-
-
-
Adana, 터키 (Türkiye), 01120
- Medical Park Seyhan Hastanesi
-
Ankara, 터키 (Türkiye), 6520
- Memorial Ankara Hastanesi
-
Ankara, 터키 (Türkiye), 06010
- Hacettepe Üniversitesi Kanser Enstitüsü
-
Edirne, 터키 (Türkiye), 22130
- Trakya Üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi
-
Etlik, 터키 (Türkiye), 06010
- Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi
-
Istanbul, 터키 (Türkiye), 34214
- Bagcilar Medipol Mega Universite Hastanesi
-
Istanbul, 터키 (Türkiye), 34722
- T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
-
Çankaya, 터키 (Türkiye), 06800
- T.C. Saglik Bakanligi Ankara Bilkent Sehi?r Hastanesi?
-
-
-
-
Greater Poland Voivodeship
-
Pozna?, Greater Poland Voivodeship, 폴란드, 60-569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
-
-
Lublin Voivodeship
-
Lublin, Lublin Voivodeship, 폴란드, 20-954
- Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
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Lódzkie
-
Lodz, Lódzkie, 폴란드, 90-302
- Instytut MSF
-
-
-
-
-
Quimper, 프랑스, 29000
- CH Cornouaille Quimper
-
-
Alsace
-
Strasbourg, Alsace, 프랑스, 67091
- Les Hôpitaux Universitaires de Strasbourg
-
-
Basse-Normandie
-
Caen, Basse-Normandie, 프랑스, 14033
- Hôpital Côte De Nacre
-
-
Limousin
-
Limoges, Limousin, 프랑스, 87042
- Centre Hospitalier Universitaire Limoges
-
-
Île-de-France Region
-
Boulogne-Billancourt, Île-de-France Region, 프랑스, 92100
- Hôpital Ambroise-Paré
-
Paris, Île-de-France Region, 프랑스, 75248
- Institut Curie
-
-
-
-
-
City of Muntinlupa, 필리핀 제도, 1780
- Asian Hospital and Medical Center
-
-
Metropolitan Manila
-
Quezon City, Metropolitan Manila, 필리핀 제도, 1112
- St. Luke's Medical Center - Quezon City
-
-
National Capital Region
-
Pasig, National Capital Region, 필리핀 제도, 1605
- The Medical City
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion-
-
Provide written informed consent.
-
≥18 years of age (or meets the country's regulatory definition for legal adult age, whichever is greater).
-
Pathologically confirmed, locally advanced or metastatic nonsquamous NSCLC
-
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:
- Treatment duration did not exceed 8 weeks;
- 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);
- Associated toxicities have resolved to baseline; and
- 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.
-
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:
- Part A: EGFR ex20ins or other uncommon single or compound EGFR mutation
- Part B: EGFR ex20ins mutation
-
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.
-
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.
-
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.
-
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
-
Adequate organ function, as defined by the laboratory value
-
Have a life expectancy of at least 3 months as assessed by the investigator.
-
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).
-
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 -
-
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.
-
Prior treatment with any of the following within the specific time frame specified:
- Zipalertinib (TAS6417/CLN-081) at any time.
- 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.
- Major surgery (excluding placement of vascular access) ≤28 days prior to first dose of study treatment.
- 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.
-
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.
-
Past medical history of interstitial lung disease, treatment-related pneumonitis (any grade), or any evidence of clinically active interstitial lung disease.
-
Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- History of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification .
- Serious cardiac arrhythmias requiring treatment.
- Resting corrected QT interval (QTc) >470 msec calculated using Fridericia's formula (QTcF).
-
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).
-
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:
- Adequately treated basal or squamous cell carcinoma of the skin
- Cancer of the breast or cervix in situ
- 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
- Concurrent malignancy determined to be clinically stable and not requiring tumor directed treatment
-
Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is unstable or not controlled with treatment.
-
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.
-
Active bleeding disorders.
-
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.
-
History of leptomeningeal disease and spinal cord compression.
-
Is unable or unwilling to take dexamethasone, folic acid, and/or vitamin B12 supplementation during treatment with pemetrexed.
-
Is pregnant or lactating or planning to become pregnant
-
The patient is, in the investigator's opinion, unable or unwilling to comply with the trial procedures.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
oral tablets
다른 이름들:
|
|
실험적: 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. |
oral tablets
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
파트 A 및 B: 치료 응급 AE의 비율 및 중증도
기간: 약 5년
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약 5년
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파트 A 및 파트 B: 맹검 독립 중앙 검토(BICR)에 의한 무진행 생존(PFS)
기간: 약 5년
|
약 5년
|
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파트 A: 주기 1 동안 NCI-CTCAE(Common Terminology Criteria of Adverse Events) v5.0에 따른 DLT의 비율 및 심각도
기간: 약 5년
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약 5년
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
파트 A 및 파트 B: 객관적 반응률(ORR)
기간: 약 5년
|
약 5년
|
|
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파트 A 및 파트 B: 질병 통제율(DCR)
기간: 약 5년
|
약 5년
|
|
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파트 A 및 파트 B: 대응 기간(DoR)
기간: 약 5년
|
약 5년
|
|
|
파트 A 및 파트 B: 두개내(i) 전체 반응률(iORR)
기간: 약 5년
|
약 5년
|
|
|
파트 A 및 파트 B: 완전 반응의 두개내 기간(iDCR)
기간: 약 5년
|
약 5년
|
|
|
파트 A 및 파트 B: 두개내 반응 기간(iDoR)
기간: 약 5년
|
약 5년
|
|
|
파트 B: 전체 생존(OS)
기간: 약 5년
|
약 5년
|
|
|
Pharmacokinetic (PK) parameter
기간: approximately 5 years
|
Minimum observed concentration (Cmin) |
approximately 5 years
|
|
European Quality of Life 5 Dimensions, 3 Level Version (EQ-5D-3L)
기간: 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
기간: 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 )
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pharmacokinetic (PK) parameter
기간: approximately 5 years
|
Minimum Plasma Concentration [Cmin] |
approximately 5 years
|
|
Pharmacokinetic (PK) parameter
기간: approximately 5 years
|
Maximum Plasma Concentration [Cmax] |
approximately 5 years
|
|
Pharmacokinetic (PK) parameter
기간: approximately 5 years
|
Area Under Curve [AUC] |
approximately 5 years
|
|
EGFR mutation status
기간: approximately 5 years
|
local central tests results |
approximately 5 years
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- TAS6417-301
- 2023-503575-21 (EudraCT 번호)
- 2023 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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