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Eine Studie zu Pirtobrutinib (LOXO-305) im Vergleich zu Bendamustin plus Rituximab (BR) bei unbehandelten Patienten mit chronischer lymphatischer Leukämie (CLL)/kleinem lymphatischem Lymphom (SLL) (BRUIN-CLL-313)

24. September 2026 aktualisiert von: Loxo Oncology, Inc.

Eine offene, randomisierte Phase-3-Studie zu Pirtobrutinib (LOXO-305) im Vergleich zu Bendamustin plus Rituximab bei unbehandelten Patienten mit chronischer lymphatischer Leukämie/kleinem lymphatischem Lymphom

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

282

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

  • Australien
    • New South Wales
      • Liverpool, New South Wales, Australien, 2170
        • Liverpool Hospital
      • Wentworthville, New South Wales, Australien, 2145
        • Westmead Hospital
    • Victoria
      • Frankston, Victoria, Australien, 3199
        • Peninsula Private Hospital
  • Brasilien
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90050-170
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90110270
        • Centro Gaucho Integrado - Mae de Deus Center
    • São Paulo
      • Campinas, São Paulo, Brasilien, 13083-878
        • Hemocentro Unicamp
      • Jaú, São Paulo, Brasilien, 17210120
        • Fundação Doutor Amaral Carvalho
  • Bulgarien
      • Plovdiv, Bulgarien, 4000
        • UMHAT "Sveti Georgi" EAD
      • Sofia, Bulgarien, 1431
        • UMHAT 'Sv. Ivan Rilski', EAD
      • Sofia, Bulgarien, 1797
        • "SHATHD" EAD, Sofia
      • Stara Zagora, Bulgarien, 6003
        • UMHAT - Prof. Dr. Stoyan Kirkovich" AD
  • China
      • Beijing, China, 100730
        • Beijing Hospital
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
    • Anhui
      • Hefei, Anhui, China, 233004
        • Anhui Provincial Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010050
        • The Affiliated Hospital of Inner Mongolia Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyany, Liaoning, China, 110022
        • Shengjing Hospital of China Medical University
    • Nanjing
      • Nanjing, Nanjing, China, 210029
        • Jiangsu Province Hospital
    • Shanghai Municipality
      • Changning District, Shanghai Municipality, China, 200050
        • Shanghai Tongren Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin Municipality, China, 300020
        • Institute of hematology&blood disease hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 311100
        • The First People's Hospital of Hangzhou Linping District
  • Frankreich
      • Le Mans, Frankreich, 72000
        • Hospitalier Le Mans
  • Italien
      • Bergamo, Italien, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
      • Brescia, Italien, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
      • Meldola, Italien, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan, Italien, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Milan, Italien, 20162
        • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
      • Monza, Italien, 20900
        • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
      • Novara, Italien, 28100
        • Azienda Ospedale Maggiore Della Carita
      • Perugia, Italien, 06132
        • Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
      • Ravenna, Italien, 48020
        • Ospedale Santa Maria delle Croci
      • Terni, Italien, 05100
        • Azienda Ospedaliera Santa Maria Terni
      • Trieste, Italien, 34125
        • Azienda sanitaria integrata università di Trieste
    • Potenza
      • Rionero in Vulture, Potenza, Italien, 85028
        • Irccs Crob
  • Japan
      • Aomori, Japan, 030-8553
        • Aomori Prefectural Centeral Hospital
      • Fukoka-ken, Japan, 806 8501
        • JCHO Kyushu Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Chiba Cancer Center
    • Fukui
      • Yoshida-Gun, Fukui, Japan, 910-1193
        • Fukui Medical University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0030006
        • Hokuyukai Sapporo Hokuyu Hospital
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
        • Kochi Medical School Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Sendai, Miyagi, Japan, 9838520
        • NHO Sendai Medical Center
    • Saitama
      • Koshigaya, Saitama, Japan, 343 8555
        • Dokkyo Medical University - Koshigaya Hospital
    • Yamanshi
      • Chūō, Yamanshi, Japan, 409-3821
        • University of Yamanashi Hospital
  • Neuseeland
      • Christchurch, Neuseeland, 8011
        • Christchurch Hospital
      • Papatoetoe, Neuseeland, 2025
        • Middlemore Clinical Trials
    • Auckland
      • Takapuna, Auckland, Neuseeland, 0622
        • North Shore Hospital, Haematology Research
    • Bay of Plenty
      • Tauranga, Bay of Plenty, Neuseeland, 3112
        • Tauranga Hospital
  • Polen
      • Biała Podlaska, Polen, 21500
        • KO-MED Centra Kliniczne
      • Bydgoszcz, Polen, 85-168
        • Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
      • Katowice, Polen, 40519
        • Pratia Onkologia Katowice
      • Krakow, Polen, 30727
        • Pratia MCM Krakow
      • Lublin, Polen, 20-090
        • Centrum Onkologii Ziemi Lubelskiej
      • Torun, Polen, 87-100
        • Nasz Lekarz Osrodek Badan Klinicznych
      • Warsaw, Polen, 02781
        • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
      • Wroclaw, Polen, 50-367
        • Uniwersytecki Szpital Kliniczny Klinika
    • Legnica
      • Iwaszkiewicza 5, Legnica, Polen, 59-220
        • Wojewodzki Szpital Specjalistyczny
    • Lubelskie V
      • Lublin, Lubelskie V, Polen, 20081
        • Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polen, 80214
        • Uniwersyteckie Centrum Kliniczne
    • Poznan
      • Skorzewo, Poznan, Polen, 60 185
        • Centrum Medyczne Pratia Poznan
  • Portugal
      • Braga, Portugal, 4710-243
        • Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
      • Lisbon, Portugal, 1649035
        • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  • Rumänien
      • Bucharest, Rumänien, 022328
        • Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
      • Cluj-Napoca, Rumänien, 400015
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
      • Iași, Rumänien, 700483
        • Institutului Regional de Oncologie IASI
    • Dolj
      • Craiova, Dolj, Rumänien, 200143
        • Spitalul Clinic Municipal Filantropia Craiova
  • Russland
      • Saint Petersburg, Russland, 197022
        • Academician I.P. Pavlov First St-Petersburg State Medical University
  • Spanien
      • Barcelona, Spanien, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Spanien, 28040
        • Hospital Universitario Fundación Jiménez Díaz
      • Seville, Spanien, 41013
        • Hospital Universitario Virgen del Rocío
      • Seville, Spanien, 41014
        • Hospital Universitario Virgen de Valme
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spanien, 28050
        • Hospital Universitario HM Sanchinarro
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spanien, 33011
        • Hospital Universitario Central de Asturias
  • Südkorea
      • Busan, Südkorea, 47392
        • Inje Univ Busan Paik Hospital
    • Incheon-gwangyeoksi [Incheon]
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], Südkorea, 21565
        • Gachon University Gil Medical Center
    • Seoul
      • Seocho-Gu, Seoul, Südkorea, 06591
        • The Catholic University of Korea-Seoul St. Mary's Hospital
    • Seoul, Korea
      • Seoul, Seoul, Korea, Südkorea, 03080
        • Seoul National University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Südkorea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [Seoul], Südkorea, 06351
        • Samsung Medical Center
  • Taiwan
      • Changhua, Taiwan, 50544
        • Chang Bing Show Chwan Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital - Linkou
  • Tschechien
      • Brno, Tschechien, 62500
        • Fakultni nemocnice Brno
      • Hradec Králové, Tschechien, 500 05
        • Fakultni nemocnice Hradec Kralove
  • Ungarn
      • Debrecen, Ungarn, 4032
        • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
      • Nyíregyháza, Ungarn, 4400
        • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
      • Székesfehérvár, Ungarn, 8000
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90027
        • California Research Institute
      • Whittier, California, Vereinigte Staaten, 90603
        • Innovative Clinical Research Institute
    • Florida
      • Coral Springs, Florida, Vereinigte Staaten, 33065
        • Oncology-Hematology Associates of West Broward
    • New Jersey
      • Brick, New Jersey, Vereinigte Staaten, 08724
        • New Jersey Center for Cancer Research
    • New York
      • Westbury, New York, Vereinigte Staaten, 11590
        • Clinical Research Alliance, Inc.
  • Vereinigtes Königreich
    • England
      • Birmingham, England, Vereinigtes Königreich, B9 5SS
        • Birmingham Heartlands Hospital
  • Österreich
      • Salzburg, Österreich, 5020
        • Uniklinikum Salzburg
      • Vienna, Österreich, 1160
        • Klinik Ottakring

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 Criteria:

  • Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Adequate organ function
  • Platelets greater than or equal to (≥)75 x 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L
  • Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min)

Exclusion Criteria:

  • Known or suspected Richter's transformation at any time preceding enrollment

  • Prior systemic therapy for CLL/SLL

  • Presence of 17p deletion

  • Central nervous system (CNS) involvement

  • Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])

  • Significant cardiovascular disease

  • Active hepatitis B or hepatitis C

  • Active cytomegalovirus (CMV) infection

  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection

  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count

  • Concurrent use of investigational agent or anticancer therapy except hormonal therapy

  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist

  • Vaccination with a live vaccine within 28 days prior to randomization

  • Patients with the following hypersensitivity:

    • Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
    • Prior significant hypersensitivity to rituximab

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: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm A - Pirtobrutinib

Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
Arzneimittel: Pirtobrutinib

Oral

Andere Namen:
  • LOXO-305
  • LY3527727
Aktiver Komparator: Arm B - Bendamustine Plus Rituximab

Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).
Arzneimittel: Bendamustine

IV

Andere Namen:
  • Treanda
  • Levakt
  • Ribomustin
  • Trakisym
Arzneimittel: Rituximab

IV

Andere Namen:
  • Rituxan
  • MabThera
  • Riabni
  • Ruhe
  • Truxima

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC)
Zeitfenster: From randomization until documented disease progression or death (up to 40 months)

PFS, as assessed by IRC, is defined as the time from randomization until documented disease progression as per iwCLL (International Workshop on Chronic Lymphocytic Leukemia) 2018 criteria, or death from any cause, whichever occurs first.
From randomization until documented disease progression or death (up to 40 months)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Investigator
Zeitfenster: From randomization until documented disease progression or death (up to 40 months)

PFS, as assessed by investigator, is defined as the time from randomization until documented disease progression as per iwCLL (International Workshop on Chronic Lymphocytic Leukemia) 2018 criteria, or death from any cause, whichever occurs first.
From randomization until documented disease progression or death (up to 40 months)
To Evaluate the Effectiveness of Arm A Compared to Arm B: Overall Survival (OS)
Zeitfenster: Up to approximately 5 years

Assessments of effectiveness include OS, assessed by investigator
Up to approximately 5 years
Arm A Compared to Arm B: Time to Next Treatment (TTNT), Assessed by Investigator
Zeitfenster: From randomization until initiation of the subsequent anticancer therapy or death (up to 41 months)

TTNT is defined as time from the date of randomization to the date of initiation of the subsequent anticancer therapy for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) including the first dose date of pirtobrutinib for Arm B participants who crossed over to receive pirtobrutinib if applicable or death due to any cause, whichever occurs first.
From randomization until initiation of the subsequent anticancer therapy or death (up to 41 months)
Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by IRC
Zeitfenster: From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)

ORR, as assessed by IRC, is defined as number of participants who achieved a best overall response of complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR) or partial remission (PR) at or before the initiation of subsequent anticancer therapy, disease progression or death, divided by the total number of participants randomized to each treatment arm.
From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)
Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by Investigator
Zeitfenster: From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)

ORR, as assessed by investigator, is defined as number of participants who achieved a best overall response of complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR) or partial remission (PR) at or before the initiation of subsequent anticancer therapy, disease progression or death, divided by the total number of participants randomized to each treatment arm.
From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)
Arm A Compared to Arm B: Duration of Response (DOR), Assessed by IRC
Zeitfenster: From first documented response until the first documented disease progression or death (up to 35 months)

DoR, as assessed by IRC, is defined as the time from the date of the first documented response (CR, CRi, nPR, or PR) until the first date of the documentation of disease progression as per iwCLL 2018 criteria, or the date of death from any cause, whichever occurs first.
From first documented response until the first documented disease progression or death (up to 35 months)
Arm A Compared to Arm B: Duration of Response (DOR), Assessed by Investigator
Zeitfenster: From first documented response until the first documented disease progression or death (up to 35 months)

DoR, as assessed by investigator, is defined as the time from the date of the first documented response (CR, CRi, nPR, or PR) until the first date of the documentation of disease progression as per iwCLL 2018 criteria, or the date of death from any cause, whichever occurs first.
From first documented response until the first documented disease progression or death (up to 35 months)
Arm A Compared to Arm B: Time to Worsening (TTW) of CLL/SLL-related Symptoms as Measured by the EORTC QLQ-C30 and IL-58
Zeitfenster: From randomization up to 37 months

A measure of CLL/SLL-related symptoms (CLL/SLL-related Symptoms score) was derived from 13 items: appetite loss, fatigue (3 items), pain, nausea, dyspnea, and insomnia from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and night sweats, fever/chills, and fatigue (3 items) from selected items of the EORTC Item Library set 58 (IL-58). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing worse symptoms. TTW of CLL/SLL-related symptoms was defined as the time from randomization to the earliest date of the first sustained worsening in its score from baseline, meeting or exceeding the meaningful within-person change (MWPC) threshold of +5.12 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints.
From randomization up to 37 months
Arm A Compared to Arm B: Time to Worsening (TTW) of Physical Functioning as Measured by the Physical Function Domain of the EORTC-QLQ-C30
Zeitfenster: From randomization up to 37 months

Physical Functioning was assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30) Physical Function (PF) scale consisting of 5 items to measure the impact of the disease and its treatment on a participant's ability to perform everyday physical activities, calculated from responses to the five items, each scored on a 4 point scale (1 = not at all to 4 = very much). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing better functioning. TTW of PF was defined as the time from randomization to the earliest date of the first sustained worsening from baseline, with a decline in the meaningful within-person change (MWPC) threshold of -13.33 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints.
From randomization up to 37 months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Arm A Compared to Arm B: Overall Survival, Assessed by Investigator
Zeitfenster: From randomization until death from any cause (up to 41 months)

Overall survival (OS) is defined as the time from randomization until death from any cause. A descriptive analysis of OS was pre-specified based on the primary endpoint data cutoff.
From randomization until death from any cause (up to 41 months)

Mitarbeiter und Ermittler

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

Sponsor

Loxo Oncology, Inc.

Mitarbeiter

Eli Lilly and Company

Ermittler

  • Studienleiter: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

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

Nützliche Links

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)

23. September 2021

Primärer Abschluss (Tatsächlich)

11. Juli 2025

Studienabschluss (Geschätzt)

1. Oktober 2027

Studienanmeldedaten

Zuerst eingereicht

24. August 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. August 2021

Zuerst gepostet (Tatsächlich)

27. August 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 18088
  • LOXO-BTK-20023 (Andere Kennung: Eli Lilly and Company)
  • J2N-OX-JZNP (Andere Kennung: Eli Lilly and Company)
  • 2024-511599-33-00 (Ctis)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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