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AzTrials

Chronic Lymphocytic LeukemiaPhase 3BRUIN-CLL-313NCT05023980

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

A Phase 3 study testing Pirtobrutinib, Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Loxo Oncology, Inc. at 108 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pirtobrutinib, Bendamustine and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
282 participants
Where
108 sitesin 20 countries
Study dates
23 Sep 2021to Oct 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

108 sites in 20 countries.

108 sites in 20 countries

China19 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing Hospital

    Beijing, 100730

  • Shanghai Tongren Hospital

    Changning District, Shanghai Municipality, 200050

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing Cancer Hospital

    Chongqing, 400030

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • The First People's Hospital of Hangzhou Linping District

    Hangzhou, Zhejiang, 311100

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 233004

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Hospital

    Nanjing, Nanjing, 210029

  • Shengjing Hospital of China Medical University

    Shenyany, Liaoning, 110022

  • Institute of hematology&blood disease hospital

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Italy12 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

    Milan, 20162

  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

    Monza, 20900

  • Azienda Ospedale Maggiore Della Carita

    Novara, 28100

  • Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)

    Perugia, 06132

  • Ospedale Santa Maria delle Croci

    Ravenna, 48020

  • Irccs Crob

    Rionero in Vulture, Potenza, 85028

  • Azienda Ospedaliera Santa Maria Terni

    Terni, 05100

  • Azienda sanitaria integrata università di Trieste

    Trieste, 34125

Other trials in Italy

Poland12 sites

  • KO-MED Centra Kliniczne

    Biała Podlaska, 21500

  • Szpital Uniwersytecki nr 1 im. Antoniego Jurasza

    Bydgoszcz, 85-168

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80214

  • Wojewodzki Szpital Specjalistyczny

    Iwaszkiewicza 5, Legnica, 59-220

  • Pratia Onkologia Katowice

    Katowice, 40519

  • Pratia MCM Krakow

    Krakow, 30727

  • Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin

    Lublin, Lubelskie V, 20081

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090

  • Centrum Medyczne Pratia Poznan

    Skorzewo, Poznan, 60 185

  • Nasz Lekarz Osrodek Badan Klinicznych

    Torun, 87-100

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy

    Warsaw, 02781

  • Uniwersytecki Szpital Kliniczny Klinika

    Wroclaw, 50-367

Other trials in Poland

Japan11 sites

  • Aomori Prefectural Centeral Hospital

    Aomori, 030-8553

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • University of Yamanashi Hospital

    Chūō, Yamanshi, 409-3821

  • JCHO Kyushu Hospital

    Fukoka-ken, 806 8501

  • Dokkyo Medical University - Koshigaya Hospital

    Koshigaya, Saitama, 343 8555

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Kochi Medical School Hospital

    Nankoku, Kochi, 783-8505

  • Hokuyukai Sapporo Hokuyu Hospital

    Sapporo, Hokkaido, 0030006

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • NHO Sendai Medical Center

    Sendai, Miyagi, 9838520

  • Fukui Medical University Hospital

    Yoshida-Gun, Fukui, 910-1193

Other trials in Japan

South Korea6 sites

  • Inje Univ Busan Paik Hospital

    Busan, 47392

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565

  • The Catholic University of Korea-Seoul St. Mary's Hospital

    Seocho-Gu, Seoul, 06591

  • Seoul National University Hospital

    Seoul, Seoul, Korea, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 03722

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

Other trials in South Korea

Spain6 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario HM Sanchinarro

    Madrid, Madrid, Comunidad de, 28050

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario Virgen de Valme

    Seville, 41014

Other trials in Spain

United States5 sites

  • New Jersey Center for Cancer Research

    Brick, New Jersey, 08724

  • Oncology-Hematology Associates of West Broward

    Coral Springs, Florida, 33065

  • California Research Institute

    Los Angeles, California, 90027

  • Clinical Research Alliance, Inc.

    Westbury, New York, 11590

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

Brazil5 sites

  • Hemocentro Unicamp

    Campinas, São Paulo, 13083-878

  • Fundação Doutor Amaral Carvalho

    Jaú, São Paulo, 17210120

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Centro Gaucho Integrado - Mae de Deus Center

    Porto Alegre, Rio Grande do Sul, 90110270

Other trials in Brazil

Bulgaria4 sites

  • UMHAT "Sveti Georgi" EAD

    Plovdiv, 4000

  • UMHAT 'Sv. Ivan Rilski', EAD

    Sofia, 1431

  • "SHATHD" EAD, Sofia

    Sofia, 1797

  • UMHAT - Prof. Dr. Stoyan Kirkovich" AD

    Stara Zagora, 6003

Other trials in Bulgaria

New Zealand4 sites

  • Christchurch Hospital

    Christchurch, 8011

  • Middlemore Clinical Trials

    Papatoetoe, 2025

  • North Shore Hospital, Haematology Research

    Takapuna, Auckland, 0622

  • Tauranga Hospital

    Tauranga, Bay of Plenty, 3112

Other trials in New Zealand

Romania4 sites

  • Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular

    Bucharest, 022328

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

    Cluj-Napoca, 400015

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, Dolj, 200143

  • Institutului Regional de Oncologie IASI

    Iași, 700483

Other trials in Romania

Taiwan4 sites

  • Chang Bing Show Chwan Memorial Hospital

    Changhua, 50544

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 333

Other trials in Taiwan

Australia3 sites

  • Peninsula Private Hospital

    Frankston, Victoria, 3199

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Westmead Hospital

    Wentworthville, New South Wales, 2145

Other trials in Australia

Hungary3 sites

  • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

    Debrecen, 4032

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

Other trials in Hungary

Portugal3 sites

  • Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)

    Braga, 4710-243

  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, 1649035

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

Other trials in Portugal

Austria2 sites

  • Uniklinikum Salzburg

    Salzburg, 5020

  • Klinik Ottakring

    Vienna, 1160

Other trials in Austria

Czechia2 sites

  • Fakultni nemocnice Brno

    Brno, 62500

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

Other trials in Czechia

France1 site

  • Hospitalier Le Mans

    Le Mans, 72000

Other trials in France

Russia1 site

  • Academician I.P. Pavlov First St-Petersburg State Medical University

    Saint Petersburg, 197022

Other trials in Russia

United Kingdom1 site

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

Other trials in United Kingdom

About this study

Official title: A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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.

Being tested
Pirtobrutinib, Bendamustine, Rituximab
Keywords
BTKi, BTK Inhibitor, Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-cell
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Diseases, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PirtobrutinibDrug

    Also called LOXO-305, LY3527727

    Oral

  • BendamustineDrug

    Also called Treanda, Treakisym, Ribomustin, Levact

    IV

  • RituximabDrug

    Also called Rituxan, MabThera, Truxima, Riabni

    IV

Study groups in NCT05023980
Study groupRoleWhat they receive
Arm A - PirtobrutinibExperimentalParticipants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
Receives: Drug: Pirtobrutinib
Arm B - Bendamustine Plus RituximabActive comparatorParticipants 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).
Receives: Drug: Bendamustine; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC)

    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.

    Measured: From randomization until documented disease progression or death (up to 40 months)

Secondary outcomes (9)

  1. Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Investigator

    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.

    Measured: From randomization until documented disease progression or death (up to 40 months)

  2. To Evaluate the Effectiveness of Arm A Compared to Arm B: Overall Survival (OS)

    Assessments of effectiveness include OS, assessed by investigator

    Measured: Up to approximately 5 years

  3. Arm A Compared to Arm B: Time to Next Treatment (TTNT), Assessed by Investigator

    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.

    Measured: From randomization until initiation of the subsequent anticancer therapy or death (up to 41 months)

  4. Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by IRC

    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.

    Measured: From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)

  5. Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by Investigator

    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.

    Measured: From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)

  6. Arm A Compared to Arm B: Duration of Response (DOR), Assessed by IRC

    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.

    Measured: From first documented response until the first documented disease progression or death (up to 35 months)

  7. Arm A Compared to Arm B: Duration of Response (DOR), Assessed by Investigator

    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.

    Measured: From first documented response until the first documented disease progression or death (up to 35 months)

  8. 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

    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.

    Measured: From randomization up to 37 months

  9. 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

    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.

    Measured: From randomization up to 37 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study start23 Sep 2021
  3. Primary completion11 Jul 2025
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible patients will be randomized 1:1 into Arm A and Arm B. Patients randomized to Arm B who have disease progression (PD) confirmed by independent review committee (IRC) may be eligible to crossover into Arm A.
Masking
None (open label)
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05023980
Sponsor's protocol ID
18088
Other IDs
J2N-OX-JZNP, LOXO-BTK-20023, 2024-511599-33-00
Acronym
BRUIN-CLL-313
Status last verified
Sep 2026
First submitted
24 Aug 2021
Last updated
25 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eyre TA, Hess LM, Masoudi E, Jen MH, Abhyankar S, Graham-Clarke PL, Bhandari NR, Maguire P, Winfree KB, Tracey M, Taipale KL, Davids MS. Efficacy of Pirtobrutinib Monotherapy in Treatment-Naive Chronic Lymphocytic Leukemia: A Bayesian Network Meta-Analysis of Randomized Controlled Trials. Cancers (Basel). 2026 Feb 18;18(4):660. doi: 10.3390/cancers18040660.

    PubMed 41749915

  • Jurczak W, Kwiatek M, Czyz J, Roberto de Mattos E, Eom KS, Egle A, Panovska A, Popova ZG, Shih HJ, Casado Montero LF, Sportoletti P, Hua VM, D'Olimpio JT, Iida S, Ito R, Bao K, Fink A, Su W, Ruppert AS, Levy A, Wrobel T. BRUIN CLL-313: Randomized Phase III Trial of Pirtobrutinib Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. J Clin Oncol. 2026 Feb 20;44(6):466-475. doi: 10.1200/JCO-25-02380. Epub 2025 Dec 9.

    PubMed 41363773

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pirtobrutinib, Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Loxo Oncology, Inc. at 108 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in China, Italy, Poland, Japan, South Korea and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC) (time frame: From randomization until documented disease progression or death (up to 40 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05023980, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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