Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
NCT ID: NCT04248829
Last Updated: 2024-12-03
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
393 participants
INTERVENTIONAL
2020-02-13
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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
TREATMENT
QUADRUPLE
Study Groups
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Lazertinib + Gefitinib-matching placebo
Lazertinib (240 mg or 160 mg orally, once daily) plus Gefitinib-matching placebo (250 mg orally, once daily) in accordance with the randomization schedule
Lazertinib 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-matching placebo 250 mg
The initial dose for Gefitinib-matching placebo (250 mg once daily) cannot be reduced to a lower dose
Gefitinib + Lazertinib-matching placebo
Gefitinib (250 mg orally, once daily) plus Lazertinib-matching placebo (240 mg or 160 mg orally, once daily) in accordance with the randomization schedule
Gefitinib 250 mg
The initial dose for Gefitinib (250 mg once daily) cannot be reduced to a lower dose
Lazertinib-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
Interventions
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Lazertinib 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 mg
The initial dose for Gefitinib (250 mg once daily) cannot be reduced to a lower dose
Lazertinib-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 mg
The initial dose for Gefitinib-matching placebo (250 mg once daily) cannot be reduced to a lower dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Locations
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Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Eugenideio Therapeutirio - Ongcology Department
Athens, , Greece
Attikon Hospital
Athens, , Greece
Theageneio Anticancer Hospital of Thessaloniki
Thessaloniki, , Greece
Debreceni Egyetem
Debrecen, , Hungary
Törökbálinti Tüdőgyógyintézet
Törökbálint, , Hungary
Hospital Sultan Ismail
Johor Bahru, Johor, Malaysia
Hospital Raja Perempuan Zainab Ii
Kota Bharu, Kelantan, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Selangor, Malaysia
Manila Doctors Hospital - Clinical Trial Office
Manila, Quezon, Philippines
Perpetual Succour Hospital
Cebu, , Philippines
Philippine General Hospital
Manila, , Philippines
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, Russia
GBUZ of Nizhny Novgorod region Clinical diagnostic center
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
GAUZ Republican clinical oncology dispensary of the Ministry
Kazan', , Russia
Republic Clinical Oncology Despensary
Kazan', , Russia
Medincentre (GLAVUPDK)
Moscow, , Russia
VitaMed LLC
Moscow, , Russia
MBUZ City Clinical Hospital #1
Novosibirsk, , Russia
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
Omsk, , Russia
Private medical institution "Euromedservice"
Pushkin, , Russia
First St. Petersburg State Medical University n. a. Pavlov
Saint Petersburg, , Russia
LLC "Eurocityclinic"
Saint Petersburg, , Russia
Limited Liability Company "AV Medical Group" - Oncology
Saint Petersburg, , Russia
Saint-Petersburg City Clinical Oncology Dispensary
Saint Petersburg, , Russia
GBUZ "Regional clinical oncologic dispensary of Volgograd"
Volgograd, , Russia
Yaroslavl regional oncology hospital
Yaroslavl, , Russia
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, Vojvodina, Serbia
Clinical Hospital Center "Bezanijska Kosa"
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
National University Hospital
Singapore, , Singapore
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
The Catholic University of Korea, Eunpyeong St.Mary's Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Chiang Mai University - Faculty of Medicine
Chiang Mai, , Thailand
Prince of Songkla University
Hat Yai, , Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, , Thailand
Adana Baskent Practice and Research Hospital
Adana, , Turkey (Türkiye)
Cukurova University Medical Faculty
Adana, , Turkey (Türkiye)
Ankara Liv Hospital
Ankara, , Turkey (Türkiye)
Hacettepe University Medical Faculty - Medical Oncology
Ankara, , Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, , Turkey (Türkiye)
Istanbul Medeniyet University Goztepe Training and Research Hospital - Medical Oncology
Istanbul, , Turkey (Türkiye)
Medical Point İzmir Hospital
Izmir, , Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, , Turkey (Türkiye)
Inonu University Turgut Ozal Medical Center
Malatya, , Turkey (Türkiye)
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasnyi klinichnyi spetsializovanyi dyspanser radiatsiinoho zakhystu naselennia" - khirurhichne viddilennia
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Tsentralna miska klinichna likarnia
Uzhhorod, Zakarpattia Oblast, Ukraine
Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr", strukturnyi pidrozdil klinichnoi onkolohii, m.Chernivtsi
Chernivtsi, , Ukraine
Komunalne nekomertsiine pidpryiemstvo "Miska klinichna likarnia №4" Dniprovskoi miskoi rady", khimioterapevtychne viddilennia z dennym statsionarom, Derzhavnyi zaklad "Dnipropetrovskyi derzhavnyi medychnyi universitet", kafedra onkolohii i medychnoi radio
Dnipro, , Ukraine
Kyiv City Clinical Oncology Center - Department of Chemotherapy
Kyiv, , Ukraine
Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady "Sumskyi klinichnyi onkolohichnyi tsentr", onkotorakalne viddilennia, Sumskyi derzhavnyi universytet, kafedra onkolohii ta radiolohii, m. Sumy
Sumy, , Ukraine
Podilskyi rehionalnyi tsentr onkolohii, viddilennia khimioterapii
Vinnytsia, , Ukraine
Medychnyi tsentr Tovarystva z obmezhenoiu vidpovidalnistiu "Onkolaif"
Zaporizhzhia, , Ukraine
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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YH25448-301
Identifier Type: -
Identifier Source: org_study_id