A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Start Date
12/10/2025
Completion Date
9/1/2030
Summary
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 490 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan as a monotherapy or in combination with oral osimertinib. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Telisotuzumab Adizutecan
Standard of Care
Osimertinib
Conditions
Locations
Highlands Oncology Group - Springdale /ID# 277132
Springdale, Arkansas 72762
United States
City of Hope National Medical Center /ID# 277005
Duarte, California 91010
United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928
Irvine, California 92618
United States
Cancer Specialists of North Florida /ID# 277332
Jacksonville, Florida 32256
United States
Cancer Care Centers of Brevard- Rockledge /ID# 277853
Rockledge, Florida 32955
United States
Moffitt Cancer Center /ID# 276785
Tampa, Florida 33612
United States
Parkview Research Center /ID# 277651
Fort Wayne, Indiana 46845
United States
HealthPartners Cancer Research Center /ID# 277339
Saint Louis Park, Minnesota 55426
United States
Nho - Revive Research Institute /ID# 277569
Lincoln, Nebraska 68506
United States
Dartmouth-Hitchcock Medical Center /ID# 277673
Lebanon, New Hampshire 03756
United States
Astera Cancer Care /ID# 277570
East Brunswick, New Jersey 08816-4096
United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
Knoxville, Tennessee 37909
United States
SCRI Oncology Partners /ID# 276959
Nashville, Tennessee 37203
United States
Fred Hutchinson Cancer Center. /ID# 277939
Seattle, Washington 98109-4405
United States
Northwest Cancer Specialists - Vancouver /ID# 277855
Vancouver, Washington 98684
United States
Canberra Hospital /ID# 277166
Garran, Australian Capital Territory 2605
Australia
St George Hospital - Kogarah /ID# 277168
Kogarah, New South Wales 2217
Australia
Mater Hospital Brisbane /ID# 276985
South Brisbane, Queensland 4101
Australia
Icon Cancer Centre Hobart /ID# 277549
Hobart, Tasmania 7000
Australia
St Vincent's Hospital Melbourne /ID# 277002
Fitzroy, Victoria 03065
Australia
Sunshine Hospital /ID# 276894
St Albans, Victoria 3021
Australia
One Clinical Research - Nedlands /ID# 277598
Nedlands, Western Australia 6009
Australia
Klinik Floridsdorf /ID# 276679
Vienna, State of Vienna 1210
Austria
Institut Jules Bordet /ID# 277283
Anderlecht, Brussels Capital 1070
Belgium
Grand Hopital de Charleroi - Les Viviers /ID# 277282
Charleroi, Hainaut 6280
Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 278951
Liège, Liege 4000
Belgium
Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202
Hasselt, Limburg 3500
Belgium
Universitair Ziekenhuis Leuven /ID# 276874
Leuven, Vlaams-Brabant 3000
Belgium
Guangdong Provincial People's Hospital /ID# 277631
Guangzhou, Guangdong 510080
China
The First affiliated hospital of Nanchang University (Xianghu campus) /ID# 277491
Nanchang, Jiangxi 330209
China
Shanghai Pulmonary Hospital /ID# 277488
Shanghai, Shanghai Municipality 200433
China
Xinjiang Medical University Cancer Hospital - Urumqi /ID# 277638
Ürümqi, Xinjiang 830000
China
CHU Brest - Hopital de la Cavale Blanche /ID# 277883
Brest, Finistere 29200
France
CHU de Lille - Institut Coeur Poumon /ID# 276868
Lille, Hauts-de-France 59000
France
Hopital Arnaud de Villeneuve /ID# 276872
Montpellier, Herault 34090
France
Institut Curie /ID# 277623
Paris, Île-de-France Region 75248
France
Universitaetsklinikum Heidelberg /ID# 277275
Heidelberg, Baden-Wurttemberg 69120
Germany
Universitaetsklinikum Wuerzburg /ID# 277213
Würzburg, Bavaria 97080
Germany
Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873
Marburg, Hesse 35043
Germany
Universitaetsklinikum Koeln /ID# 276862
Cologne, North Rhine-Westphalia 50937
Germany
Universitätsklinikum Jena /ID# 277281
Jena, Thuringia 07747
Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 276869
Hamburg, 20246
Germany
Meir Medical Center /ID# 277289
Kefar Sava, Central District 4428164
Israel
Rabin Medical Center /ID# 276748
Petah Tikva, Central District 4941492
Israel
Yitzhak Shamir Medical Center /ID# 276750
Ẕerifin, Central District 7030000
Israel
The Chaim Sheba Medical Center /ID# 276745
Ramat Gan, Tel Aviv 5265601
Israel
Rambam Health Care Campus- Haifa /ID# 276746
Haifa, 3109601
Israel
Istituto Europeo Di Oncologia /ID# 276788
Milan, Milano 20141
Italy
AST Pesaro Urbino - Presidio Ospedaliero Santa Croce Di Fano /ID# 277338
Fano, Pesaro E Urbino 61032
Italy
Centro Di Riferimento Oncologico /ID# 276923
Aviano, Pordenone 33081
Italy
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 277296
Rome, Roma 00144
Italy
Ospedale Isola Tiberina - Gemelli Isola /ID# 277117
Rome, Roma 00186
Italy
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119
Candiolo, Torino 10060
Italy
AOU Policlinico G. Rodolico - San Marco /ID# 277265
Catania, 95123
Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 277280
Verona, 37126
Italy
Hokkaido University Hospital /ID# 277240
Sapporo, Hokkaido 060-8648
Japan
Kitasato University Hospital /ID# 277241
Sagamihara-shi, Kanagawa 252-0375
Japan
National Cancer Center Hospital /ID# 277093
Chuo-Ku, Tokyo 104-0045
Japan
Wakayama Medical University Hospital /ID# 277238
Wakayama, Wakayama 641-8510
Japan
Radboudumc /ID# 277639
Nijmegen, Gelderland 6525 GA
Netherlands
Leids Universitair Medisch Centrum /ID# 277270
Leiden, South Holland 2333 ZA
Netherlands
Erasmus Medisch Centrum /ID# 276989
Rotterdam, South Holland 3015 CE
Netherlands
Universitair Medisch Centrum Utrecht /ID# 277114
Utrecht, 3584 CX
Netherlands
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 277066
Poznan, Greater Poland Voivodeship 60-569
Poland
Pratia MCM Krakow /ID# 277118
Krakow, Lesser Poland Voivodeship 30-727
Poland
Provita Centrum Medyczne /ID# 277494
Warsaw, Masovian Voivodeship 00-585
Poland
Uniwersyteckie Centrum Kliniczne /ID# 277210
Gdansk, Pomeranian Voivodeship 80-214
Poland
Gyncentrum Sp. z o.o. /ID# 277522
Sosnowiec, Silesian Voivodeship 41-208
Poland
Unidade Local de Saude do Alto Ave, EPE /ID# 277249
Guimarães, Braga District 4835-044
Portugal
Unidade Local de Saude de Loures-Odivelas /ID# 277223
Loures, Lisbon District 2674-514
Portugal
Unidade Local de Saude de Matosinhos EPE /ID# 277228
Senhora da Hora, Porto District 4464-513
Portugal
Unidade Local de Saude de Braga, EPE /ID# 277217
Braga, 4710-243
Portugal
Unidade Local de Saude de Santo Antonio /ID# 277216
Porto, 4099-003
Portugal
Hospital Cuf Porto /ID# 277225
Porto, 4100-180
Portugal
University Clinical Center Serbia /ID# 277051
Belgrade, Beograd 11000
Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 277052
Belgrade, Beograd 11080
Serbia
University Clinical Center Nis /ID# 277200
Niš, Nisavski Okrug 18300
Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 277047
Kamenitz, Sremski Okrug 21208
Serbia
University Clinical Center Kragujevac /ID# 277162
Kragujevac, Sumadijski Okrug 34000
Serbia
National Cancer Center /ID# 277353
Goyang-si, Gyeonggido 10408
South Korea
Chungbuk National University Hospital /ID# 277372
Cheongju-si, North Chungcheong 28644
South Korea
Seoul National University Hospital /ID# 277373
Seoul, Seoul Teugbyeolsi 03080
South Korea
Yonsei University Health System Severance Hospital /ID# 277394
Seoul, Seoul Teugbyeolsi 03722
South Korea
Asan Medical Center /ID# 277371
Seoul, Seoul Teugbyeolsi 05505
South Korea
Samsung Medical Center /ID# 277600
Seoul, Seoul Teugbyeolsi 06351
South Korea
Complejo Hospitalario Universitario de Santiago /ID# 277173
Santiago de Compostela, A Coruna 15706
Spain
Hospital Universitari Parc Tauli /ID# 277177
Sabadell, Barcelona 08208
Spain
Hospital Universitari Vall d Hebron /ID# 277156
Barcelona, 08035
Spain
Hospital Universitario Ramon y Cajal /ID# 277153
Madrid, 28034
Spain
Hospital Universitario 12 de Octubre /ID# 277155
Madrid, 28041
Spain
Hospital Universitario Virgen de la Victoria /ID# 277159
Málaga, 29010
Spain
Hospital Clinico Universitario de Valencia /ID# 277147
Valencia, 46010
Spain
Hospital Clinico Universitario Lozano Blesa /ID# 277154
Zaragoza, 50009
Spain
Changhua Christian Hospital /ID# 277145
Changhua, 500
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138
Kaohsiung City, 807
Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 277472
Kaohsiung City, 833
Taiwan
Taichung Veterans General Hospital /ID# 277142
Taichung, 407
Taiwan
Mackay Memorial Hospital /ID# 277146
Taipei, 104
Taiwan
National Taiwan University Cancer Center (Ntucc) /ID# 277134
Taipei, 106
Taiwan
Taipei Veterans General Hospital /ID# 277141
Taipei, 112
Taiwan
Linkou Chang Gung Memorial Hospital /ID# 277135
Taoyuan City, 333
Taiwan
Sakarya Universitesi Tip Fakultesi - Korucuk Kampusu /ID# 276962
Adapazarı, Sakarya 54290
Turkey (Türkiye)
Adana Sehir Hastanesi /ID# 276957
Adana, 01370
Turkey (Türkiye)
Gazi University Medical Faculty /ID# 276943
Ankara, 06560
Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 276961
Ankara, 06620
Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276956
Istanbul, 34722
Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 277063
Istanbul, 34899
Turkey (Türkiye)
Samsun Medical Park Hastanesi /ID# 277201
Samsun, 55200
Turkey (Türkiye)
St Bartholomews Hospital - Barts Health /ID# 277301
London, Greater London EC1A 7BE
United Kingdom
The Christie NHS Foundation Trust - Christie Hospital /ID# 277304
Manchester, M20 4BX
United Kingdom