Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
- Trial number:
- NCT04248829
- Trial phase:
- 3
- Study type:
- Targeted therapy
- Overall status:
- Active, not recruiting
Study start date
February, 2020
Scientific 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
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
Pathologically confirmed adenocarcinoma of the lungLocally 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
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Intervention 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, Subject masked:
Yes, Caregiver masked:
Yes, Investigator masked:
Yes, Outcomes assessor masked:
Yes,
Conditions
Non-Small Cell Lung Cancer
Other study ID numbers
YH25448-301
Choose trial site (126)
Debreceni Egyetem
Debrecen, Hungary
Calvary Mater Newcastle
Edith &, Platt St, Waratah NSW 2298, Australia
The Townsville Hospital
The Townsville Hospital, 100 Angus Smith Dr, Douglas QLD 4814, Australia
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102, Australia
Peninsula & South Eastern Haematology and Oncology Group
205 Bell St, Preston VIC 3072, Australia
General Hospital Of Chest Diseases Of Athens "Sotiria"
Mesogion 152, Athina 115 27, Greece
Eygenidio Therapeftirio - Oncology Department
Kidantidon 41, Athina 118 51, Greece
Attikon Hospital
Rimini 1, Chaidari 124 62, Greece
University General Hospital of Larissa
Larisa 413 34, Greece
Theageneio Anticancer Hospital of Thessaloniki
Al. Papanastasiou 11, Thessaloniki 546 39, Greece
Bioclinic Thessaloniki
Mitropoleos 86, Thessaloniki 546 22, Greece
Veszprem Megyei Onkormanyzat Tudogyogyintezete
Veszprém, Hungary
Fejér Megyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, Seregélyesi út 3, 8000 Hungary
Szent Borbála Kórház
Tatabánya, Dózsa György út 77, 2800 Hungary
Törökbálinti Tüdőgyógyintézet
Törökbálint, Munkácsy Mihály u. 70, 2045 Hungary
Chungbuk National University Hospital
South Korea, Chungcheongbuk-do, Cheongju, 서원구 Seonghwa.gaesin.jungnim-dong, 1(il) Sunhawn-ro, 776 KR
Yonsei Universtiy, Wonju Severance Christian Hospital
20 Ilsan-ro, Ilsan-dong, Weonju, Gangwon-do, South Korea
Hallym University Sacred Heart Hospital
22 Gwanpyeong-ro 170beon-gil, Pyeongan-dong, Dongan-gu, Anyang, Gyeonggi-do, South Korea
Soon Chun Hyang University Hospital Bucheon
170 Jomaru-ro, Jung 1(il)-dong, Bucheon, Gyeonggi-do, South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
327 Sosa-ro, Sosa-dong, Wonmi-gu, Bucheon, Gyeonggi-do, South Korea
National Cancer Center
Ilsan-ro, 마두1동 Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea
CHA Bundang Medical Center, CHA University
59 Yatap-ro, Yatap-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
South Korea, Gyeonggi-do, Seongnam-si, Bundang-gu, Gumi-dong, Gumi-ro 173(baekchilsipsam)beo, 82 KR
The Catholic University of Korea, St. Vincent's Hospital
93 Jungbu-daero, Ji-dong, Paldal-gu, Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
164 Woldeukeom-ro, Woncheon-dong, Yeongtong-gu, Suwon, Gyeonggi-do, South Korea
Gyeongsang National University Hospital
15 Jinju-daero 816beon-gil, Juyak-dong, Jinju, Gyeongsangnam-do, South Korea
Inje University Haeundae Paik Hospital
875 Haeun-daero, Jwa-dong, Haeundae, Busan, South Korea
Yeungnam University Medical Center
Daemyeong-dong, Daegu, South Korea
Keimyung University Dongsan Medical Center
1035 Dalgubeol-daero, Sindang-dong, Dalseo-gu, Daegu, South Korea
Gachon University Gil Medical Center
21 Namdong-daero 774beon-gil, Guwol-dong, Namdong-gu, Incheon, South Korea
Korea University Anam Hospital
73 Inchon-ro, Anam-dong, Seongbuk-gu, Seoul, South Korea
Seoul National University Hospital
101 Daehak-ro, Yeongeon-dong, Jongno-gu, Seoul, South Korea
Kangbuk Samsung Hospital
29 Saemunan-ro, Pyeong-dong, Jongno-gu, Seoul, South Korea
The Catholic University of Korea, Eunpyeong St.Mary's Hospital
1021 Tongil-ro, Jingwan-dong, Eunpyeong-gu, Seoul, South Korea
Severance Hospital
50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, South Korea
Asan Medical Center
88 Olympic-ro 43-gil, Pungnap 2(i)-dong, Songpa-gu, Seoul, South Korea
Samsung Medical Center
81 Irwon-ro, Irwonbon-dong, Gangnam-gu, Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
222 Banpo-daero, Banpo-dong, Seocho-gu, Seoul, South Korea
Chung-Ang University Hospital
South Korea, Seoul, Dongjak-gu, Heukseok-dong, Heukseok-ro, 102 KR 06973
SMG-SNU Boramae Medical Center
20 Boramae-ro 5-gil, Sindaebang-dong, Dongjak-gu, Seoul, South Korea
Korea University Guro Hospital
148 Gurodong-ro, Guro-dong, Guro-gu, Seoul, South Korea
Ulsan University Hospital
877 Bangeojinsunhwan-doro, Jeonha-dong, Dong-gu, Ulsan, South Korea
Hospital Sultan Ismail
Jalan Mutiara Emas Utama, Taman Mount Austin, 81100 Johor Bahru, Johor, Malaysia
Hospital Raja Perempuan Zainab Ii
15586, Jalan Hospital, Bandar Kota Bharu, 15200 Kota Bharu, Kelantan, Malaysia
Hospital Tengku Ampuan Afzan
Jalan Tanah Putih, 25100 Kuantan, Pahang, Malaysia
Hospital Pulau Pinang
Jalan Residensi, 10990 George Town, Pulau Pinang, Malaysia
Hospital Umum Sarawak
Jalan Hospital, 93586 Kuching, Sarawak, Malaysia
University Malaya Medical Centre
Jalan Universiti, 59100 Kuala Lumpur, Selangor, Malaysia
Manila Doctors Hospital - Clinical Trial Office
667 United Nations Ave, Ermita, Manila, 1000 Metro Manila, Philippines
Dr. Pablo O. Torre Memorial Hospital
BS Aquino Dr, Bacolod, 6100 Negros Occidental, Philippines
Perpetual Succour Hospital
Gorordo Ave, Cebu City, 6000 Cebu, Philippines
Philippine General Hospital
Taft Ave, Ermita, Manila, 1000 Metro Manila, Philippines
Lung Center of the Philippines
Quezon Ave, Diliman, Quezon City, 1100 Metro Manila, Philippines
Arkhangelsk Regional Clinical Oncological Dispensary
Prospekt Lomonosova, 292, Arkhangel'sk, Arkhangelskaya oblast', Russia, 163045
Kursk Regional Oncology Dispensary
Kursk Oblast, Russia, 305524
GBUZ of Nizhny Novgorod region Clinical diagnostic center
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603006
Pyatigorsk Oncology Center
Pyatigorsk, Stavropol Krai, Russia, 357502
GAUZ Republican clinical oncology dispensary of the Ministry
Kazan, Republic of Tatarstan, Russia, 420029
Republic Clinical Oncology Despensary
Kazan, Republic of Tatarstan, Russia, 420029
LLC Medicine 24/7 - Oncology
Moscow, Russia, 115280
VitaMed LLC
Seslavinskaya Ulitsa, 10, Moskva, Russia, 121309
MBUZ City Clinical Hospital #1
Novosibirsk, Novosibirsk Oblast, Russia
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
Omsk Oblast, Russia, 644013
Private medical institution "Euromedservice"
St Petersburg, Russia, 196603
First St. Petersburg State Medical University n. a. Pavlov
Ulitsa L'va Tolstogo, 6-8, Sankt-Peterburg, Russia, 197022
LLC "Eurocityclinic"
Медиков проспект, дом 10, корп.1, лит. А, помещение 47-Н, Sankt-Peterburg, Russia, 197022
Limited Liability Company "AV Medical Group" - Oncology
Turistskaya Ulitsa, 18 корпус 1, Sankt-Peterburg, Russia, 197082
Saint-Petersburg City Clinical Oncology Dispensary
St Petersburg, Russia, 198255
GBUZ "Saint-Petersburg Clinical Scientific and Practical Center of Specialized Types of Care (Oncology)"
St. Petersburg, FL, USA
GBUZ "Regional clinical oncologic dispensary of Volgograd"
Volgograd, Volgograd Oblast, Russia, 400138
Yaroslavl regional oncology hospital
Sovetskaya Ulitsa, 18, Yaroslavl', Yaroslavskaya oblast', Russia, 150003
Institute for Pulmonary Diseases of Vojvodina
Institutski put 4, Sremska Kamenica 21204, Serbia
Clinical Center of Serbia
Pasterova 2, Beograd 11000, Serbia
Institute for Oncology and Radiology of Serbia
Pasterova 14, Beograd, Serbia
Special hospital for Internal diseases, Oncomed system
Karpoševa 91, Beograd, Serbia
Clinical Hospital Center "Bezanijska Kosa"
Bežanijska kosa, Beograd, Serbia
Clinical Center Kragujevac
Zmaj Jovina 30, Kragujevac, Serbia
Clinical Center Nis
Bulevar Dr Zorana Đinđića 48, Niš 18000, Serbia
National University Hospital 119074
5 Lower Kent Ridge Rd, Singapore 119074
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Oncology
No. 123號, Dapi Road, Niaosong District, Kaohsiung City, Taiwan 833
China Medical University Healthcare System
No. 2, Yude Road, North District, Taichung City, Taiwan 404
National Cheng Kung University Hospital
No. 138號, Shengli Road, North District, Tainan City, Taiwan 704
National Taiwan University Hospital
No. 7號, Zhongshan South Road, Zhongzheng District, Taipei City, Taiwan 100
Taipei Veterans General Hospital
No. 201, Section 2, Shipai Road, Beitou District, Taipei City, Taiwan 112
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Pulmonary
No. 5, Fuxing Street, Guishan District, Taoyuan City, Taiwan 333
Chulalongkorn University
254 Phayathai Rd, Khwaeng Pathum Wan, Khet Pathum Wan, Krung Thep Maha Nakhon 10330, Thailand
Ramathibodi Hospital, Mahidol University
1 Thanon Rama VI, Khwaeng Thung Phaya Thai, Khet Ratchathewi, Krung Thep Maha Nakhon 10400, Thailand
Siriraj Hospital
2 Thanon Wang Lang, Khwaeng Siriraj, Khet Bangkok Noi, Krung Thep Maha Nakhon 10700, Thailand
Chiang Mai University - Faculty of Medicine
เลขที่ 110 ถนนอินทวโรรส ซอย 2 Tambon Su Thep, Amphoe Mueang Chiang Mai, Chang Wat Chiang Mai 50200, Thailand
Prince of Songkla University
15 ถนนกาญจนวนิช Kho Hong, Amphoe Hat Yai, Chang Wat Songkhla 90110, Thailand
Srinagarind Hospital, Khon Kaen University
Nai Mueang, Mueang Khon Kaen District, Khon Kaen 40000, Thailand
Adana Baskent Practice and Research Hospital
Adana, Reşatbey, Seyhan/Adana, Turkey
Cukurova University Medical Faculty
Balcalı, Çukurova Üniversitesi Rektörlüğü, 01330 Sarıçam/Adana, Turkey
Hacettepe University Medical Faculty - Medical Oncology
Hacettepe, Hacettepe Ünv. Tıp Fakültesi Hst., 06230 Altındağ/Ankara, Turkey
Ankara University Medical Faculty - Oncology
Cebeci, 06590 Çankaya/Ankara, Turkey
Trakya University Medical Faculty
Şükrüpaşa, 22030 Edirne Merkez/Edirne, Turkey
Istanbul University Cerrahpasa Medical Faculty
Cerrahpaşa, Koca Mustafapaşa Cd. No:53 D:No:53, 34096 Fatih/İstanbul, Turkey
Istanbul Medeniyet University Goztepe Training and Research Hospital - Medical Oncology
Dumlupınar D100 Karayolu No:98, Dumlupınar, 34720 Kadıköy/İstanbul, Turkey
Ege University Medical Faculty
Kazımdirik, Ege Ünv. Hst. No:9, 35100 Bornova/İzmir, Turkey
T.C. Saglik Bakanligi - Izmir Dr.Suat Seren Gogus Hastaliklari Ve Cerrahisi Egitim Ve Arastirma Hastanesi
Yenişehir, Gaziler Cd No:331 D:28, 35170 Konak/İzmir, Turkey
Izmir Medical Park Hospital - Medical Oncology
Yeni Girne Bulvarı, İmbatlı, 1825. Sk. No:12, 35575 Karşıyaka/İzmir, Turkey
Kocaeli University Medical Faculty
Kabaoğlu, Kocaeli Ünv. Tıp Fakültesi, 41380 Umuttepe/İzmit/Kocaeli, Turkey
Necmettin Erbakan University Meram Medical Faculty - Oncology
Konya, Turkey
Inonu University Turgut Ozal Medical Center
Bulgurlu, Malatya Elazığ Yolu 10.KM No:44210, 44000 Battalgazi/Malatya, Turkey
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasnyi klinichnyi spetsializovanyi dyspanser radiatsiinoho zakhystu naselennia" - khirurhichne viddilennia
Kharkiv, Kharkiv Oblast, Ukraine
Komunalne pidpryiemstvo "Volynskyi oblasnyi medychnyi tsentr onkolohii" Volynskoyi oblasnoyi rady
Lutsk, Volyn Oblast, Ukraine
Tsentralna miska klinichna likarnia
Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
Chernivtsi Regional Oncology Center
Chernivtsi, Chernivtsi Oblast, Ukraine, 58000
Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr"
Chernivtsi, Chernivtsi Oblast, Ukraine, 58000
Komunalne nekomertsiine pidpryiemstvo "Miska klinichna likarnia №4" Dniprovskoi miskoi rady"
Likarnia, Dnipropetrovs'k, Dnipropetrovs'ka oblast, Ukraine, 49000
S.P. Grigoreva Institute of medical radiology
Kharkiv, Kharkiv Oblast, Ukraine
Kyiv City Clinical Oncology Center - Department of Chemotherapy
Verkhovynna St, 69, Kyiv, Ukraine, 03115
Sumskyi oblasnyi klinichnyi onkolohichnyi dyspanser
Sumy, Sumy Oblast, Ukraine, 40000
Zakarpatskyi obl onkodyspanser
Onkodyspanser, Uzhhorod, Zakarpats'ka oblast, Ukraine, 88000
Podilskyi rehionalnyi tsentr onkolohii, viddilennia khimioterapii
Vinnytsia, Vinnytsia Oblast, Ukraine, 21000
Medychnyi tsentr Tovarystva z obmezhenoiu vidpovidalnistiu "Onkolaif"
Zaporizhzhia, Zaporizhia Oblast, Ukraine, 69061
University General Hospital Of Patras - Dpt Of Medicine, Division Oncology
Rio 265 04, Greece
Siberian State Medical University
Moskovskiy Trakt, 2, Tomsk, Tomskaya oblast', Russia, 634050
Ankara Liv Hospital
Kavaklıdere, Bestekar Cd No:8, 06680 Çankaya/Ankara, Turkey
Eugenideio Therapeutirio - Ongcology Department
Kidantidon 41, Athina 118 51, Greece
National Cancer Center
809 Madu 1(il)-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea
Medincentre (GLAVUPDK)
Ulitsa Prechistenka, 20, стр. 3, Moskva, Russia, 119034
Medical Point İzmir Hospital
Yeni Girne Bulvarı, İmbatlı, 1825. Sk. No:12, 35575 Karşıyaka/İzmir, Türkiye
Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr", strukturnyi pidrozdil klinichnoi onkolohii, m.Chernivtsi
Chernivtsi, Chernivtsi Oblast, Ukraine, 58000
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, Dnipropetrovsk Oblast, Ukraine, 49000
Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady "Sumskyi klinichnyi onkolohichnyi tsentr", onkotorakalne viddilennia, Sumskyi derzhavnyi universytet, kafedra onkolohii ta radiolohii, m. Sumy
Sumy, Sumy Oblast, Ukraine, 40000