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Eine Studie zu Zipalertinib und Chemotherapie im Vergleich zur alleinigen Chemotherapie bei Patienten mit fortgeschrittenem nicht-kleinzelligem Lungenkrebs mit Exon 20-Insertion des epidermalen Wachstumsfaktorrezeptors (EGFR). (REZILIENT3)

30. Oktober 2026 aktualisiert von: Taiho Oncology, Inc.

Randomisierte, kontrollierte, offene, globale multizentrische Phase-3-Studie zur Bewertung der Wirksamkeit und Sicherheit der Chemotherapie mit Zipalertinib plus im Vergleich zur alleinigen Chemotherapie bei Patienten mit zuvor unbehandeltem, lokal fortgeschrittenem oder metastasiertem nicht-plattenepithelialem nicht-kleinzelligem Lungenkrebs (NSCLC) Mit Exon-20-Insertionsmutationen (ex20ins) des epidermalen Wachstumsfaktorrezeptors (EGFR).

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

285

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: TAS6417

oral tablets

Andere Namen:
  • CLN-081
  • Zipalertinib
Experimental: 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.
Arzneimittel: TAS6417

oral tablets

Andere Namen:
  • CLN-081
  • Zipalertinib

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Teil A und B: Häufigkeit und Schwere der behandlungsbedingten Nebenwirkungen
Zeitfenster: ca. 5 Jahre
ca. 5 Jahre
Teil A und Teil B: Progressionsfreies Überleben (PFS) durch verblindete unabhängige zentrale Überprüfung (BICR)
Zeitfenster: ca. 5 Jahre
ca. 5 Jahre
Teil A: Die Rate und der Schweregrad von DLTs gemäß den NCI-Common Terminology Criteria of Adverse Events (CTCAE) v5.0 während Zyklus 1
Zeitfenster: ca. 5 Jahre
ca. 5 Jahre

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Teil A und Teil B: Objektive Rücklaufquote (ORR)
Zeitfenster: ca. 5 Jahre
ca. 5 Jahre
Teil A und Teil B: Krankheitskontrollrate (DCR)
Zeitfenster: ca. 5 Jahre
ca. 5 Jahre
Teil A und Teil B: Dauer der Reaktion (DoR)
Zeitfenster: ca. 5 Jahre
ca. 5 Jahre
Teil A und Teil B: Intrakranielle (i) Gesamtansprechrate (iORR)
Zeitfenster: ca. 5 Jahre
ca. 5 Jahre
Teil A und Teil B: Intrakranielle Dauer der vollständigen Reaktion (iDCR)
Zeitfenster: ca. 5 Jahre
ca. 5 Jahre
Teil A und Teil B: Intrakranielle Reaktionsdauer (iDoR)
Zeitfenster: ca. 5 Jahre
ca. 5 Jahre
Teil B: Gesamtüberleben (OS)
Zeitfenster: ca. 5 Jahre
ca. 5 Jahre
Pharmacokinetic (PK) parameter
Zeitfenster: approximately 5 years

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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pharmacokinetic (PK) parameter
Zeitfenster: approximately 5 years

Minimum Plasma Concentration [Cmin]
approximately 5 years
Pharmacokinetic (PK) parameter
Zeitfenster: approximately 5 years

Maximum Plasma Concentration [Cmax]
approximately 5 years
Pharmacokinetic (PK) parameter
Zeitfenster: approximately 5 years

Area Under Curve [AUC]
approximately 5 years
EGFR mutation status
Zeitfenster: approximately 5 years

local central tests results
approximately 5 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Taiho Oncology, Inc.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. Dezember 2023

Primärer Abschluss (Geschätzt)

27. Mai 2027

Studienabschluss (Geschätzt)

27. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

11. Juli 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juli 2023

Zuerst gepostet (Tatsächlich)

3. August 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TAS6417-301
  • 2023-503575-21 (EudraCT-Nummer)
  • 2023 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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