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Non Small Cell Lung CancerPhase 3PRESERVE-003NCT05671510

ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

A Phase 3 study testing Gotistobart and Docetaxel in people with Non Small Cell Lung Cancer, run by OncoC4, Inc. at 152 sites in 12 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 goal of this Phase 3 clinical trial is to study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Gotistobart and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
152 sitesin 12 countries
Study dates
28 Jun 2023to 31 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Adult (≥ 18 years), all genders, capable of signing informed consent.
  • Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs.
  • Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b:
  • At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy;
  • Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy.
  • Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed.
Show all 10Show fewer
  • At least one measurable tumor lesion according to RECIST 1.1.
  • ECOG score of 0 or 1.
  • Adequate organ functions. Serum LDH level ≤ 2xULN.
  • Life expectancy ≥ 3 months.

Who cannot join

  • Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy.
  • Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment.
  • Receiving systemic steroid therapy with >10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.
  • Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK;. Exception: KRAS mutations are not excluded.
  • Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug.
  • Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.
Show all 9Show fewer
  • Active interstitial lung disease (ILD) or non-infectious pneumonitis.
  • Active infections with IV antibiotics within 14 days prior to first dose of study treatment.
  • Impaired heart function.

Trial locations and contacts

152 sites in 12 countries.

152 sites in 12 countries

United States46 sites

  • St. Luke's University Health Network - 1179

    Bethlehem, Pennsylvania, 18015

  • Miami Valley Hospital - 1115

    Centerville, Ohio, 45459

  • The Oncology Institute (TOI) Clinical Research - 1109

    Cerritos, California, 90703

  • University of Cincinnati Cancer Center - 1107

    Cincinnati, Ohio, 45219

  • The Ohio State University James Cancer Center - 1104

    Columbus, Ohio, 43210

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center (USOR) - 1140

    Dallas, Texas, 75246

  • Texas Oncology - Denison - 1139

    Denison, Texas, 75020

  • XCancer/Dothan Hematology & Oncology - 1114

    Dothan, Alabama, 36303

  • Duke University Medical Center - 1158

    Durham, North Carolina, 27710

  • Astera Cancer Care - 1128

    East Brunswick, New Jersey, 08816

  • Oncology Associates of Oregon - 1138

    Eugene, Oregon, 97401

  • NEXT Oncology - Virginia - 1129

    Fairfax, Virginia, 22031

  • Fort Wayne Medical Oncology - 1133

    Fort Wayne, Indiana, 46805

  • Virginia Cancer Institute - 1149

    Henrico, Virginia, 23226

  • Oncology Consultants, P.A. - 1120

    Houston, Texas, 77024

  • Jefferson City Medical Group - 1145

    Jefferson City, Missouri, 65109

  • MidAmerica Cancer Care - 1163

    Kansas City, Missouri, 64132

  • University of Tennessee Medical Center - 1146

    Knoxville, Tennessee, 37920

  • Oncology and Hematology of South Texas - 1165

    Laredo, Texas, 78041

  • University of Kentucky - Markey Cancer Center - 1112

    Lexington, Kentucky, 40536

  • Norton Cancer Institute - 1108

    Louisville, Kentucky, 40202

  • D&H Cancer Research Center LLC - 1153

    Margate, Florida, 33063

  • Tri County Hematology & Oncology Associates, Inc - 1156

    Massillon, Ohio, 44646

  • Texas Oncology - McAllen - 1132

    McAllen, Texas, 78503

  • West Virginia University Cancer Institute - 1172

    Morgantown, West Virginia, 26505

  • Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119

    Nashville, Tennessee, 37203

  • Deaconess Chancellor Center for Oncology - 1131

    Newburgh, Indiana, 47630

  • Virginia Oncology Associates - 1136

    Norfolk, Virginia, 23502

  • Nuvance Health - 1118

    Norwalk, Connecticut, 06850

  • Ocala Oncology Center PL - 1102

    Ocala, Florida, 34474

  • AdventHealth Cancer Institute - 1105

    Orlando, Florida, 32804

  • Orlando Health - 1130

    Orlando, Florida, 32806

  • Emad Ibrahim MD Inc. - 1147

    Redlands, California, 92373

  • Genesis Cancer and Blood Institute - 1123

    Russellville, Arkansas, 72801

  • UC Davis Comprehensive Cancer Center - 1103

    Sacramento, California, 95817

  • Texas Oncology -San Antonio - 1122

    San Antonio, Texas, 78240

  • Florida Cancer Specialists -South - 1126

    Sarasota, Florida, 34232

  • Donald Guthrie Foundation - 1135

    Sayre, Pennsylvania, 18840

  • Orchard Healthcare Research, Inc. - 1116

    Skokie, Illinois, 60077

  • Springfield Clinic - The Cancer Center - 1110

    Springfield, Illinois, 62702

  • Florida Cancer Specialists -North - 1125

    The Villages, Florida, 32159

  • Cotton O'Neil Clinical Research Center - 1151

    Topeka, Kansas, 66606

  • Oklahoma Cancer Specialists and Research Institute - 1154

    Tulsa, Oklahoma, 74146

  • Bass Medical Group - 1155

    Walnut Creek, California, 94598

  • Florida Cancer Specialists -East - 1124

    West Palm Beach, Florida, 33401

  • Cancer Care Associates of York, Inc. - 1113

    York, Pennsylvania, 17403

Other trials in United States

China40 sites

  • Beijing Cancer Hospital - 3205

    Beijing, Beijing Municipality

  • Cancer Hospital, Chinese Academy of Medical Sciences - 3211

    Beijing, Beijing Municipality

  • China-Japan Friendship Hospital - 3236

    Beijing, 100029

  • Xiangya Hospital, Central South University - 3223

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital - 3209

    Changsha, Hunan

  • Chengdu Seventh People's Hospital - 3229

    Chengdu, Sichuan, 610041

  • Sichuan Cancer Hospital - 3227

    Chengdu, Sichuan, 610041

  • West China Hospital, Sichuan University - 3238

    Chengdu, 610041

  • Chongqing University Cancer Hospital - 3213

    Chongqing, Sichuan

  • Dongguan People's Hospital - 3206

    Dongguan, Guangdong

  • Fujian Medical University Union Hospital - 3225

    Fuzhou, Fujian

  • Guangdong Provincial People's Hospital - 3201

    Guangzhou, Guangdong, 510105

  • Zhujiang Hospital of Southern Medical University - 3203

    Guangzhou, Guangdong, 510280

  • The First Affiliated Hospital of Guangdong Pharmaceutical University - 3215

    Guangzhou, Guangdong

  • Hainan General Hospital - 3202

    Haikou, Hainan

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - 3219

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Zhejiang University School of Medicine - 3220

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital - 3204

    Hangzhou, Zhejiang

  • The Affiliated Tumor Hospital of Harbin Medical University - 3232

    Harbin, Heilongjiang, 150040

  • The First Affiliated Hospital of Anhui Medical University - 3221

    Hefei, Anhui, 230022

  • Anhui Medical University - The Second Hospital - 3222

    Hefei, Anhui, 231200

  • Nanjing Medical University (NMU) - Nanjing First Hospital - 3239

    Jiangse, 21006

  • Jinan Central Hospital - 3230

    Jinan, Shandong, 250013

  • Yunnan Cancer Hospital - 3231

    Kunming, Yunnan, 650118

  • The Second Affiliated Hospital of Nanchang University - 3224

    Nanchang, Jiangxi, 330006

  • The People's Hospital of Guangxi Zhuang Autonomous Region - 3228

    Nanning, Guangxi, 530021

  • Weifang Second People's Hospital - 3235

    Shandong, 261041

  • Tongji University - Shanghai Oriental Hospital (Shanghai East Hospital) - 3240

    Shanghai, 200120

  • The Second Affiliated Hospital of Soochow University - 3217

    Suzhou, Jiangsu

  • Shanxi Bethune Hospital - 3233

    Taiyuan, Shanxi, 30032

  • Tianjin Medical University Cancer Institute and Hospital - 3208

    Tianjin, Tianjin Municipality

  • Renmin Hospital of Wuhan University - 3216

    Wuhan, Hubei

  • Union Hospital Tongji Medical College - 3212

    Wuhan, Hubei

  • Hubei Cancer Hospital - 3237

    Wuhan, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University - 3218

    Xi’an, Shanxi

  • The First Affiliated Hospital of Xiamen University - 3210

    Xiamen, Fujian

  • Xuzhou Medical University - The Affiliated Hospital - 3234

    Xuzhou, Jiangsu, 221002

  • Affiliated Hospital of Hebei University - 3214

    Zhengzhou, Hebei, 71000

  • Henan Cancer Hospital - 3226

    Zhengzhou, Henan, 450008

  • The First Affliated Hospital of Zhengzhou University - 3207

    Zhengzhou, Henan

Other trials in China

Turkey (Türkiye)12 sites

  • Adana Sehir Hastanesi - 2602

    Adana

  • Baskent University Adana - 2601

    Adana

  • Hacettepe Universitesi - 2609

    Ankara, 06230

  • Ankara Bilkent Sehir Hastanesi - 2610

    Ankara, 06800

  • Akdeniz University Medical Hospital - 2606

    Antalya

  • Trakya University Faculty of Medicine Edirne - 2608

    Edirne

  • Istanbul Üniversitesi Onkoloji Enstitüsü - 2613

    Fatih, 34093

  • Koc Universitesi - 2611

    Istanbul, 34010

  • Göztepe Prof Dr. Suleyman Yalcin City Hospital - 2605

    Istanbul

  • Istanbul Bakirkoy Sadi Konuk - 2604

    Istanbul

  • Medipol University Medical Faculty Hospital - 2603

    Istanbul

  • Izmir Ekonomi Universitesi Medical Point Hastanesi - 2607

    Izmir

Other trials in Turkey (Türkiye)

Italy11 sites

  • Clinica Oncologica Ospedali Riuniti Ancona - 2311

    Ancona, 60126

  • IRCCS Istituto Tumori Giovanni Paolo II - 2306

    Bari, 70124

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - 2310

    Bergamo, 24126

  • Humanitas Istituto Clinico Catanese - 2312

    Catania, 95045

  • Ospedale San Raffaele - 2307

    Milan, 20132

  • Fondazione IRCCS Instituto Tumori Di Milano - 2305

    Milan, 20133

  • Ospedale San Gerardo di Monza - 2302

    Monza, 20900

  • Azienda Ospedaliera Universitaria "Federico II" - 2304

    Naples, 80131

  • AOU Policlinico Giaccone, Università di Palermo - 2309

    Palermo, 90129

  • Universita degli Studi di Perugia - Ospedale Santa Maria della Misericordia - 2308

    Perugia, 06132

  • Universita Campus Bio-medico Di Roma (UCBM) - Policlinico Universitario - 2303

    Roma, 00128

Other trials in Italy

United Kingdom10 sites

  • University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801

    Birmingham, England, B15 2TG

  • Cambridge University Hospitals - 2804

    Cambridge, England, CB2 0QQ

  • Edinburgh Cancer Centre - 2809

    Edinburgh, Scotland, EH54 6PP

  • Royal Devon University Healthcare NHS - 2808

    Exeter, England, EX25DW

  • University Hospital Leicester - 2806

    Leicester, England, LE1 5WW

  • Barts Health NHS Trust (St. Bartholomew's Hospital) - 2803

    London, England, EC1A 7BE

  • University College London Hospital - 2811

    London, NW1 2PG

  • The Christie NHS Foundation Trust - 2802

    Manchester, London, M20 4BX

  • South Tees Hospitals - 2807

    Middlesbrough, England, TS4 3BW

  • Torbay and South Devon NHS Foundation Trust - 2805

    Torquay, England, TQ2 7AA

Other trials in United Kingdom

South Korea7 sites

  • Chungbuk National University Hospital - 3101

    Cheongju-si, 28644

  • Keimyung University Dongsan Hospital - 3102

    Daegu, 42601

  • National Cancer Center - 3107

    Goyang-si, 10408

  • Severance Hospital, Yonsei University Health System - 3104

    Seoul, 03722

  • Asan Medical Centre - 3103

    Seoul, 05505

  • Korea University Guro Hospital - 3106

    Seoul, 08308

  • The Catholic University of Korea, St Vincent's Hospital - 3105

    Suwon, 16247

Other trials in South Korea

Germany6 sites

  • Städt. Klinikum München GmbH - 2204

    Bogenhausen, 81925

  • Kliniken Essen-Mitte - 2206

    Essen, 45136

  • Klinikum Esslingen GmbH - 2201

    Esslingen am Neckar, 73730

  • Lungenfachklinik Immenhausen - 2202

    Immenhausen, 34376

  • Klinikverbund Allgaü - Klinikum Kempten - 2205

    Immenstädt, 87509

  • Asklepios Fachkliniken Muenchen-Gauting - 2203

    Muenchen-Gauting, 82131

Other trials in Germany

Spain6 sites

  • Hospital General Universitario de Elche - 2401

    Elche, 03203

  • Hospital Universitario Lucus Augusti - 2405

    Lugo, 27003

  • Hospital General Universitario Gregorio Marañon - 2404

    Madrid, 28007

  • Hospital Regional Universitario de Malaga - 2403

    Málaga, 29010

  • Hospital General Universitario de Valencia - 2406

    Valencia, 46014

  • Fundacion Instituto Valenciano De Oncologia (IVO) - 2402

    Valencia, 56009

Other trials in Spain

Australia4 sites

  • Cancer Research SA - 3303

    Adelaide, South Australia, 5000

  • Bankstown Hospital - 3305

    Bankstown, New South Wales, 2200

  • Mater - 3301

    Newstead, Queensland, 4006

  • Western Health - Sunshine Hospital - 3307

    St Albans, Victoria, 3021

Other trials in Australia

Belgium4 sites

  • AZ Maria Middelares - 2104

    Ghent, 9000

  • Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102

    Hasselt, 3500

  • C. H. R. de la Citadelle - 2103

    Liège, 4000

  • Vitaz - Sint-niklaas Moerland - 2101

    Sint-Niklaas, 9100

Other trials in Belgium

Canada3 sites

  • BC Cancer Centre - Kelowna - 1203

    Kelowna, British Columbia

  • Saskatchewan Cancer Agency - Regina - 1201

    Regina, Saskatchewan, S4T 7T1

  • Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202

    Saskatoon, Saskatchewan, S7N 4H4

Other trials in Canada

Netherlands3 sites

  • Antoni van Leeuwenhoek - 2703

    Amsterdam, 1066 CV

  • Rijnstate Ziekenhuis - 2701

    Arnhem, 6815

  • ETZ Elisabeth - 2704

    Tilburg, 5022 GC

Other trials in Netherlands

About this study

Official title: Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

The goal of this Phase 3 clinical trial is to study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

Read the detailed description

This is a seamless 2-stage, randomized, open-label, active-controlled, Phase 3 study. The study population consists of patients with NSCLC who progressed on PD-1/PD-L1 inhibitor. Approximately 630 patients will be enrolled.

Two gotistobart dosing regimens will be tested in Stage I, and one will be selected for Stage II.

Stage I, the dose-confirmation stage, will assess the efficacy and safety of two gotistobart dosing regimens (3 mg/kg Q3W and 6 mg/kg Q3W with 2 loading doses of 10 mg/kg Q3W) in comparison to docetaxel 75 mg/m2 Q3W.

Stage II will assess the safety and efficacy of gotistobart at the selected dosing regimen versus docetaxel on squamous cell NSCLC. Patients will be randomized 1:1 to receive either gotistobart at the selected dosing regimen or docetaxel.

Being tested
Gotistobart, Docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • GotistobartDrug

    Also called A humanized anti-CTLA4 IgG1 monoclonal antibody, ONC-392, BNT316

    Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose.

  • DocetaxelDrug

    Also called Docefrez, Taxotere

    Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose.

Study groups in NCT05671510
Study groupRoleWhat they receive
Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3WExperimentalGotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Receives: Drug: Gotistobart
Arm 2: Docetaxel 75 mg/m2, Q3WActive comparatorDocetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Receives: Drug: Docetaxel

What is being measured

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

  1. Overall Survival (OS)

    OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs.

    Measured: 36 months

Secondary outcomes (3)

  1. Objective response rate (ORR)

    Objective response rate (ORR) as assessed by the Investigator per RECIST 1.1

    Measured: 36 months

  2. Progression-free survival (PFS)

    Progression-free survival (PFS) as assessed by Investigator per RECIST 1.1

    Measured: 36 months

  3. Treatment emergent adverse events, treatment related adverse events and immune related adverse events.

    Incidence of TEAEs, TRAEs, irAEs will be calculated. The AEs leading to treatment discontinuation will be recorded.

    Measured: 36 months

Timeline

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

  1. First posted4 Jan 2023
  2. Study start28 Jun 2023
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2028 (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
Randomized, open-label, active controlled, multi-center Phase 3 study.
Masking
None (open label)
Enrolment
630 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05671510
Sponsor's protocol ID
PRESERVE-003
Other IDs
2023-505311-20-01, 2023
Acronym
PRESERVE-003
Status last verified
Aug 2026
First submitted
26 Dec 2022
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang Y, Du X, Liu M, Tang F, Zhang P, Ai C, Fields JK, Sundberg EJ, Latinovic OS, Devenport M, Zheng P, Liu Y. Hijacking antibody-induced CTLA-4 lysosomal degradation for safer and more effective cancer immunotherapy. Cell Res. 2019 Aug;29(8):609-627. doi: 10.1038/s41422-019-0184-1. Epub 2019 Jul 2.

    PubMed 31267017

  • Liu Y, Zheng P. Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy. Trends Pharmacol Sci. 2020 Jan;41(1):4-12. doi: 10.1016/j.tips.2019.11.003. Epub 2019 Dec 10.

    PubMed 31836191

  • Cho BC, Balaraman R, Chen HJ, Yu X, Fawole A, Liu ZG, Zhang J, Wu L, Yang B, Leddon JL, Hamm J, Huang Y, Wu L, Pan P, Singh P, Beardsley A, Kayali F, Davarifar A, Lee KH, Park KU, Lee Y, Li L, Wang X, Sun M, Yu Y, Jain V, Shpyro S, Wang Q, Wenger M, Sahin U, Efuni S, Song S, He K, Zheng P, Liu Y, He K, Li T, Socinski MA, Wu YL. Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial. Nat Med. 2026 Jun;32(6):2245-2253. doi: 10.1038/s41591-026-04323-8. Epub 2026 Mar 27.

    PubMed 41896648

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gotistobart and Docetaxel in people with Non Small Cell Lung Cancer, run by OncoC4, Inc. at 152 sites in 12 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 10 inclusion and 9 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States, China, Turkey (Türkiye), Italy, United Kingdom and 7 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?

This study is still under way. Results are not available in the source record yet.

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?

Overall Survival (OS) (time frame: 36 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 NCT05671510, which also lists 3 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 13 Aug 2026.

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