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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

393

Participants

Timeline

Start Date

February 13, 2020

Primary Completion Date

July 29, 2022

Study Completion Date

June 30, 2026

Conditions
Non-Small Cell Lung Cancer
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

Trial Locations (80)

1000

Manila Doctors Hospital - Clinical Trial Office, Manila

Philippine General Hospital, Manila

1120

Adana Baskent Practice and Research Hospital, Adana

1330

Cukurova University Medical Faculty, Adana

2045

Törökbálinti Tüdőgyógyintézet, Törökbálint

3115

Kyiv City Clinical Oncology Center - Department of Chemotherapy, Kyiv

4102

Princess Alexandra Hospital, Woolloongabba

6000

Perpetual Succour Hospital, Cebu

6230

Hacettepe University Medical Faculty - Medical Oncology, Ankara

10002

National Taiwan University Hospital, Taipei

10400

Ramathibodi Hospital, Mahidol University, Bangkok

Hospital Pulau Pinang, George Town

10408

National Cancer Center, Goyang-si

10450

Hospital Umum Sarawak, Kuching

10700

Siriraj Hospital, Bangkok

11080

"Clinical Hospital Center Bezanijska Kosa", Belgrade

11217

Taipei Veterans General Hospital, Taipei

11528

Eugenideio Therapeutirio - Ongcology Department, Athens

12462

Attikon Hospital, Athens

13496

CHA Bundang Medical Center, CHA University, Seongnam-si

13620

Seoul National University Bundang Hospital, Seongnam-si

14647

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

15586

Hospital Raja Perempuan Zainab Ii, Kota Bharu

16247

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

16499

Ajou University Hospital, Suwon

21029

Podilskyi rehionalnyi tsentr onkolohii, viddilennia khimioterapii, Vinnytsia

21204

Institute for Pulmonary Diseases of Vojvodina, Kamenitz

21565

Gachon University Gil Medical Center, Incheon

22030

Trakya University Medical Faculty, Edirne

25100

Hospital Tengku Ampuan Afzan, Kuantan

28644

Chungbuk National University Hospital, Cheongju-si

34000

Clinical Center Kragujevac, Kragujevac

34722

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

35560

Medical Point İzmir Hospital, Izmir

40002

Srinagarind Hospital, Khon Kaen University, Khon Kaen

40022

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

41380

Kocaeli University Medical Faculty, Kocaeli

42415

Yeungnam University Medical Center, Daegu

42601

Keimyung University Dongsan Medical Center, Daegu

44033

Ulsan University Hospital, Ulsan

44280

Inonu University Turgut Ozal Medical Center, Malatya

48108

Inje University Haeundae Paik Hospital, Busan

49102

"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

50200

Chiang Mai University - Faculty of Medicine, Chiang Mai

52727

Gyeongsang National University Hospital, Jinju

54007

Theageneio Anticancer Hospital of Thessaloniki, Thessaloniki

58013

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

59100

University Malaya Medical Centre, Kuala Lumpur

61166

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

69059

"Medychnyi tsentr Tovarystva z obmezhenoiu vidpovidalnistiu Onkolaif", Zaporizhzhia

81100

Hospital Sultan Ismail, Johor Bahru

88000

Tsentralna miska klinichna likarnia, Uzhhorod

90110

Prince of Songkla University, Hat Yai

119034

Medincentre (GLAVUPDK), Moscow

119074

National University Hospital, Singapore

121309

VitaMed LLC, Moscow

150054

Yaroslavl regional oncology hospital, Yaroslavl

163045

Arkhangelsk Regional Clinical Oncological Dispensary, Arkhangelsk

196603

"Private medical institution Euromedservice", Pushkin

197022

First St. Petersburg State Medical University n. a. Pavlov, Saint Petersburg

"LLC Eurocityclinic", Saint Petersburg

197082

"Limited Liability Company AV Medical Group - Oncology", Saint Petersburg

198255

Saint-Petersburg City Clinical Oncology Dispensary, Saint Petersburg

400138

"GBUZ Regional clinical oncologic dispensary of Volgograd", Volgograd

420029

GAUZ Republican clinical oncology dispensary of the Ministry, Kazan'

Republic Clinical Oncology Despensary, Kazan'

603006

GBUZ of Nizhny Novgorod region Clinical diagnostic center, Nizhny Novgorod

644013

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

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03181

Kangbuk Samsung Hospital, Seoul

03312

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

03722

Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

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

07061

SMG-SNU Boramae Medical Center, Seoul

06680

Ankara Liv Hospital, Ankara

H-4012

Debreceni Egyetem, Debrecen

Unknown

MBUZ City Clinical Hospital #1, Novosibirsk

All Listed Sponsors
lead

Yuhan Corporation

INDUSTRY