Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04248829
PHASE3

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

Sponsor: Yuhan Corporation

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

393

Start Date

2020-02-13

Completion Date

2026-06

Last Updated

2024-12-03

Healthy Volunteers

No

Interventions

DRUG

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

DRUG

Gefitinib 250 mg

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

DRUG

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

DRUG

Gefitinib-matching placebo 250 mg

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

Locations (80)

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