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AzTrials

Non-Small Cell Lung CancerPhase 3NCT04248829

Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)

A Phase 3 study testing Lazertinib 240 mg/160 mg and Gefitinib 250 mg in people with Non-Small Cell Lung Cancer, run by Yuhan Corporation at 80 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations 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?
Lazertinib 240 mg/160 mg and Gefitinib 250 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
393 participants
Where
80 sitesin 13 countries
Study dates
13 Feb 2020to 22 Apr 2026
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

  • Pathologically confirmed adenocarcinoma of the lung
  • Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
  • At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations
  • Treatment-naïve for locally advanced or metastatic NSCLC
  • WHO performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization
  • At least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study Screening period

Who cannot join

  • Symptomatic and unstable brain metastases
  • Leptomeningeal metastases
  • Symptomatic spinal cord compression
  • History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
  • Any medical conditions requiring chronic continuous oxygen therapy
  • History of any malignancy other than the disease under study within 3 years before randomization
Show all 9Show fewer
  • Any cardiovascular disease as follows:
  • History of symptomatic chronic heart failure or serious cardiac arrhythmia requiring active treatment
  • History of myocardial infarction or unstable angina within 24 weeks of randomization

Trial locations and contacts

80 sites in 13 countries.

80 sites in 13 countries

South Korea22 sites

  • The Catholic University of Korea, Bucheon St. Mary's Hospital

    Bucheon-si, Gyeonggi-do, 14647

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Yeungnam University Medical Center

    Daegu, 42415

  • Keimyung University Dongsan Medical Center

    Daegu, 42601

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do, 52727

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • The Catholic University of Korea, Eunpyeong St.Mary's Hospital

    Seoul, 03312

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

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

    Seoul, 06591

  • SMG-SNU Boramae Medical Center

    Seoul, 07061

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

    Suwon, Gyeonggi-do, 16247

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Russia15 sites

  • Arkhangelsk Regional Clinical Oncological Dispensary

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • GAUZ Republican clinical oncology dispensary of the Ministry

    Kazan', 420029

  • Republic Clinical Oncology Despensary

    Kazan', 420029

  • Medincentre (GLAVUPDK)

    Moscow, 119034

  • VitaMed LLC

    Moscow, 121309

  • GBUZ of Nizhny Novgorod region Clinical diagnostic center

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603006

  • MBUZ City Clinical Hospital #1

    Novosibirsk

  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"

    Omsk, 644013

  • Private medical institution "Euromedservice"

    Pushkin, 196603

  • First St. Petersburg State Medical University n. a. Pavlov

    Saint Petersburg, 197022

  • LLC "Eurocityclinic"

    Saint Petersburg, 197022

  • Limited Liability Company "AV Medical Group" - Oncology

    Saint Petersburg, 197082

  • Saint-Petersburg City Clinical Oncology Dispensary

    Saint Petersburg, 198255

  • GBUZ "Regional clinical oncologic dispensary of Volgograd"

    Volgograd, 400138

  • Yaroslavl regional oncology hospital

    Yaroslavl, 150054

Other trials in Russia

Turkey (Türkiye)9 sites

  • Adana Baskent Practice and Research Hospital

    Adana, 1120

  • Cukurova University Medical Faculty

    Adana, 1330

  • Ankara Liv Hospital

    Ankara, 06680

  • Hacettepe University Medical Faculty - Medical Oncology

    Ankara, 6230

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul Medeniyet University Goztepe Training and Research Hospital - Medical Oncology

    Istanbul, 34722

  • Medical Point İzmir Hospital

    Izmir, 35560

  • Kocaeli University Medical Faculty

    Kocaeli, 41380

  • Inonu University Turgut Ozal Medical Center

    Malatya, 44280

Other trials in Turkey (Türkiye)

Ukraine8 sites

  • Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr", strukturnyi pidrozdil klinichnoi onkolohii, m.Chernivtsi

    Chernivtsi, 58013

  • Komunalne nekomertsiine pidpryiemstvo "Miska klinichna likarnia №4" Dniprvskoi miskoi rady", khimioterapevtychne viddilennia z dennym statsionarom, Derzhavnyi zaklad "Dnipropetrovskyi derzhavnyi medychnyi universitet", kafedra onkolohii i medychnoi radio

    Dnipro, 49102

  • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasnyi klinichnyi spetsializovanyi dyspanser radiatsiinoho zakhystu naselennia" - khirurhichne viddilennia

    Kharkiv, Kharkiv Oblast, 61166

  • Kyiv City Clinical Oncology Center - Department of Chemotherapy

    Kyiv, 3115

  • Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady "Sumskyi klinichnyi onkolohichnyi tsentr", onkotorakalne viddilennia, Sumskyi derzhavnyi universytet, kafedra onkolohii ta radiolohii, m. Sumy

    Sumy, 40022

  • Tsentralna miska klinichna likarnia

    Uzhhorod, Zakarpattia Oblast, 88000

  • Podilskyi rehionalnyi tsentr onkolohii, viddilennia khimioterapii

    Vinnytsia, 21029

  • Medychnyi tsentr Tovarystva z obmezhenoiu vidpovidalnistiu "Onkolaif"

    Zaporizhzhya, 69059

Other trials in Ukraine

Malaysia6 sites

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10400

  • Hospital Sultan Ismail

    Johor Bahru, Johor, 81100

  • Hospital Raja Perempuan Zainab Ii

    Kota Bharu, Kelantan, 15586

  • University Malaya Medical Centre

    Kuala Lumpur, Selangor, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100

  • Hospital Umum Sarawak

    Kuching, Sarawak, 10450

Other trials in Malaysia

Thailand5 sites

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Chiang Mai University - Faculty of Medicine

    Chiang Mai, 50200

  • Prince of Songkla University

    Hat Yai, 90110

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen, 40002

Other trials in Thailand

Greece3 sites

  • Eugenideio Therapeutirio - Ongcology Department

    Athens, 11528

  • Attikon Hospital

    Athens, 12462

  • Theageneio Anticancer Hospital of Thessaloniki

    Thessaloniki, 54007

Other trials in Greece

Philippines3 sites

  • Perpetual Succour Hospital

    Cebu, 6000

  • Manila Doctors Hospital - Clinical Trial Office

    Manila, Quezon, 1000

  • Philippine General Hospital

    Manila, 1000

Other trials in Philippines

Serbia3 sites

  • Clinical Hospital Center "Bezanijska Kosa"

    Belgrade, Belgrade, 11080

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz, Vojvodina, 21204

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Hungary2 sites

  • Debreceni Egyetem

    Debrecen, H-4012

  • Törökbálinti Tüdőgyógyintézet

    Törökbálint, 2045

Other trials in Hungary

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Australia1 site

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Singapore1 site

  • National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

Official title: A Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Lazertinib Versus Gefitinib as the First-line Treatment in Patients With Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations

Read the detailed description

YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) that targets both the T790M mutation and activating EGFR mutations while sparing wild type EGFR.

This is a Phase III, Randomized, Double-blind study evaluating the efficacy and safety of YH25448 (240 mg orally, once daily) versus Gefitinib (250 mg orally, once daily) in patients with locally advanced or metastatic NSCLC that is known to be EGFR sensitizing mutation (EGFRm) positive, treatment-naïve and eligible for first-line treatment with an EGFR-TKI.

Being tested
Lazertinib 240 mg/160 mg, Gefitinib 250 mg, Lazertinib-matching placebo 240 mg/160 mg, Gefitinib-matching placebo 250 mg
Keywords
Locally Advanced EGFR Sensitizing Mutation, Metastatic EGFR Sensitizing Mutation, EGFR TKI, Ex19del, L858R, First-line, YH25448, Advanced Non-Small Cell Lung Cancer, Adenocarcinoma of lung, Non-squamous carcinoma of lung, Phase III, Lazertinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

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

  • Lazertinib 240 mg/160 mgDrug

    Also called YH25448 240 mg/160 mg

    The initial dose of lazertinib 240 mg (3 tablets of 80 mg lazertinib) once daily can be reduced to 160 mg once daily (2 tablets of 80 mg lazertinib) under specific circumstances

  • Gefitinib 250 mgDrug

    Also called Iressa 250 mg

    The initial dose for Gefitinib (250 mg once daily) cannot be reduced to a lower dose

  • Lazertinib-matching placebo 240 mg/160 mgDrug

    Also called YH25448-matching placebo 240 mg/160 mg

    The initial dose of lazertinib-matching placebo 240 mg (3 tablets of 80 mg lazertinib-matching placebo) once daily can be reduced to 160 mg once daily (2 tablets of 80 mg lazertinib-matching placebo) under specific circumstances

  • Gefitinib-matching placebo 250 mgDrug

    Also called Iressa-matching placebo 250 mg

    The initial dose for Gefitinib-matching placebo (250 mg once daily) cannot be reduced to a lower dose

Study groups in NCT04248829
Study groupRoleWhat they receive
Lazertinib + Gefitinib-matching placeboExperimentalLazertinib (240 mg or 160 mg orally, once daily) plus Gefitinib-matching placebo (250 mg orally, once daily) in accordance with the randomization schedule
Receives: Drug: Lazertinib 240 mg/160 mg; Drug: Gefitinib-matching placebo 250 mg
Gefitinib + Lazertinib-matching placeboActive comparatorGefitinib (250 mg orally, once daily) plus Lazertinib-matching placebo (240 mg or 160 mg orally, once daily) in accordance with the randomization schedule
Receives: Drug: Gefitinib 250 mg; Drug: Lazertinib-matching placebo 240 mg/160 mg

What is being measured

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

  1. Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment

    PFS was defined as the time from randomization until the date of objective progression or death(by any cause whichever comes first based on investigator assessment using RECIST v1.1 and was used to assess the efficacy of lazertinib compared to the gefitinib).

    Measured: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant.

Secondary outcomes (11)

  1. Objective Response Rate (ORR) According to RECIST v1.1 by Investigator Assessments

    ORR was defined as the percentage of participants with measurable disease with at least on visit response of complete response(CR) or Partial response(PR) and it was used to further assess the efficacy of lazertinib compared with gefitinib.

    Measured: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant.

  2. Duration of Response (DoR) According to RECIST v1.1 by Investigator Assessments

    DoR was defined as the time from the date of first documented response(CR or PR) until the date of documented progression or death, whichever comes first and was used to further assess the efficacy of lazertinib compared with gefitinib.

    Measured: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant.

  3. Disease Control Rate (DCR) According to RECIST v1.1 by Investigator Assessments

    DCR was defined as the percentage of participants who have a best overall response of CR or PR or SD(SD at >= 6weeks prior to any PD event) and was used to further assess the efficacy of lazertinib compared with gefitinib.

    Measured: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant.

  4. Depth of Response According to RECIST v1.1 by Investigator Assessments

    The depth of response was defined as the best percent change in the sum of diameters of target lesions in the absense of new lesions or progression of non-target lesions compared to the baseline and was used to further assess the efficacy of lazertinib compared with gefitinib.

    Measured: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression.

  5. Time to Response According to RECIST v1.1 by Investigator Assessments

    Time to Response was defined as the time from the date of randomization until the date of first documented response and was used to further assess the efficacy of lazertinib compared with gefitinib.

    Measured: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression.

  6. Overall Survival (OS)

    OS was defined as the time from the date of randomization until the date of death due to any cause and was used to further assess the efficacy of lazertinib compared with gefitinib.

    Measured: From the randomization to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks. (Up to 29 months per participant.)

  7. Plasma Concentrations of Lazertinib

    To characterize the pharmacokinetics (PK) of lazertinib.

    Measured: Blood samples collected from each participant at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose on Day 1 Cycle 1, Day 1 Cycle 2, Day 1 Cycle 5, Day 1 Cycle 9, and Day 1 Cycle 13.

  8. Cerebrospinal Fluid (CSF) Concentrations of Lazertinib

    To characterize the pharmacokinetics (PK) of lazertinib.

    Measured: A cerebrospinal fluid (CSF) sample once collected from participants with brain metastases, at Cycle 5 Day 1 or afterward.

  9. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 Items (QLQ-C30)

    The EORTC QLQ-C30 consists of 30 items and measures cancer participants' functioning (health related quality of life (HRQoL)) and symptoms for all cancer types. Questions can be grouped into 5 multi item functional scales (physical, role, emotional, cognitive, and social); 3 multi item symptom scales (fatigue, pain, nausea/vomiting); a 2 item global HRQoL scale; 5 single items assessing additional symptoms commonly reported by cancer participants (dyspnea, loss of appetite, insomnia, constipation, diarrhea) and 1 item on the financial impact of the disease.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    • a high score for a functional scale represents a high / healthy level of functioning
    • a high score for the global health status / QoL represents a high QoL
    • but a high score for a symptom scale / item represents a high level of symptomatology / problems

    Measured: Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later).

  10. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Lung Cancer 13 Items (EORTC QLQ-LC13)

    The EORTC QLQ-LC13 includes questions assessing cough, hemoptysis, dyspnea, site specific pain (symptoms), sore mouth, dysphagia, peripheral neuropathy, and alopecia (treatment related side effects), and pain medication.

    The items on both measures were scaled and scored using the recommended EORTC procedures. Raw scores were transformed to a linear scale ranging from 0 to 100, with a higher score representing a higher level of functioning or higher level of symptoms. Provided at least half of the items in the scale were completed, the scale score was calculated using only those items for which values existed.

    Measured: Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later).

  11. Change From Baseline in Euro-Quality of Life-5 Dimension-5 Level (EQ-5D-5L)

    The EQ-5D comprises the following two questionnaires:

    • The EQ-5D comprises 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension comprises five levels (no problems, slight problems, moderate problem, severe problem, unable/extreme problems).
    • The EQ VAS records the participants self-rated health status on a vertical graduated (0-100) visual analogue scale. The patient's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS.

    Measured: Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later).

Timeline

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

  1. First posted30 Jan 2020
  2. Study start13 Feb 2020
  3. Primary completion29 Jul 2022
  4. Study completion22 Apr 2026

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
Approximately 380 patients will be randomized in a 1:1 ratio to either lazertinib (n=190) or gefitinib (n= 190). Following objective disease progression according to RECIST v1.1, as per investigator assessment, patients who were randomized to gefitinib arm may have the option to receive open-label lazertinib
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
393 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248829
Sponsor's protocol ID
YH25448-301
Status last verified
May 2026
First submitted
14 Jan 2020
Last updated
29 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to hmbyun@yuhan.co.kr. Other documents(i.e. a summary of the study results, study protocol, statistical analysis plan) will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.

Publications

  • Soo RA, Cho BC, Kim JH, Ahn MJ, Lee KH, Zimina A, Orlov S, Bondarenko I, Lee YG, Lim YN, Lee SS, Lee KH, Pang YK, Fong CH, Kang JH, Lim CS, Danchaivijitr P, Kilickap S, Yang JC, Arslan C, Lee H, Park SN, Cicin I. Central Nervous System Outcomes of Lazertinib Versus Gefitinib in EGFR-Mutated Advanced NSCLC: A LASER301 Subset Analysis. J Thorac Oncol. 2023 Dec;18(12):1756-1766. doi: 10.1016/j.jtho.2023.08.017. Epub 2023 Oct 22.

    PubMed 37865896

  • Cho BC, Ahn MJ, Kang JH, Soo RA, Reungwetwattana T, Yang JC, Cicin I, Kim DW, Wu YL, Lu S, Lee KH, Pang YK, Zimina A, Fong CH, Poddubskaya E, Sezer A, How SH, Danchaivijitr P, Kim Y, Lim Y, An T, Lee H, Byun HM, Zaric B. Lazertinib Versus Gefitinib as First-Line Treatment in Patients With EGFR-Mutated Advanced Non-Small-Cell Lung Cancer: Results From LASER301. J Clin Oncol. 2023 Sep 10;41(26):4208-4217. doi: 10.1200/JCO.23.00515. Epub 2023 Jun 28.

    PubMed 37379502

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lazertinib 240 mg/160 mg and Gefitinib 250 mg in people with Non-Small Cell Lung Cancer, run by Yuhan Corporation at 80 sites in 13 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 6 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: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in South Korea, Russia, Turkey (Türkiye), Ukraine, Malaysia and 8 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 22 Mar 2024). 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?

Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment (time frame: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant.). 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 NCT04248829, 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 29 Jun 2026.

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