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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzona diagnoza zaawansowanego raka płuca (bez komórek płaskonabłonkowych) z mutacją EGFR
- •Wcześniejsze leczenie lkiem trzeciej generacji (EGFR TKI) z dokumentowanym postępem choroby
- •Dobry ogólny stan zdrowia (ECOG 0-1)
- •Co najmniej jeden widoczny guz, który nie był wcześniej napromieniowany
- •Próbka guza dostępna do badań laboratoryjnych
✗ Disqualifies
- •Guz o innym typie histologicznym (płaskonabłonkowy, adenośluzakowy)
- •Więcej niż jedno poprzednie leczenie w stadium zaawansowanym
- •Czynne przerzuty do mózgu z objawami
- •Zapalenie tkanki płucnej lub jego historia wymagająca sterydów
- •Inne poważne problemy zdrowotne utrudniające udział w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 9, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (110)
Highlands Oncology Group - Springdale /ID# 277132
Springdale, United States
City of Hope National Medical Center /ID# 277005
Duarte, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928
Irvine, United States
Cancer Specialists of North Florida /ID# 277332
Jacksonville, United States
Cancer Care Centers of Brevard- Rockledge /ID# 277853
Rockledge, United States
Moffitt Cancer Center /ID# 276785
Tampa, United States
Parkview Research Center /ID# 277651
Fort Wayne, United States
HealthPartners Cancer Research Center /ID# 277339
Saint Louis Park, United States
Nho - Revive Research Institute /ID# 277569
Lincoln, United States
Dartmouth-Hitchcock Medical Center /ID# 277673
Lebanon, United States
Astera Cancer Care /ID# 277570
East Brunswick, United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
Knoxville, United States
SCRI Oncology Partners /ID# 276959
Nashville, United States
Fred Hutchinson Cancer Center. /ID# 277939
Seattle, United States
Northwest Cancer Specialists - Vancouver /ID# 277855
Vancouver, United States
Canberra Hospital /ID# 277166
Garran, Australia
St George Hospital - Kogarah /ID# 277168
Kogarah, Australia
Mater Hospital Brisbane /ID# 276985
South Brisbane, Australia
Icon Cancer Centre Hobart /ID# 277549
Hobart, Australia
St Vincent's Hospital Melbourne /ID# 277002
Fitzroy, Australia
Sunshine Hospital /ID# 276894
St Albans, Australia
One Clinical Research - Nedlands /ID# 277598
Nedlands, Australia
Klinik Floridsdorf /ID# 276679
Vienna, Austria
Institut Jules Bordet /ID# 277283
Anderlecht, Belgium
Grand Hopital de Charleroi - Les Viviers /ID# 277282
Charleroi, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 278951
Liège, Belgium
Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202
Hasselt, Belgium
Universitair Ziekenhuis Leuven /ID# 276874
Leuven, Belgium
Guangdong Provincial People's Hospital /ID# 277631
Guangzhou, China
The First affiliated hospital of Nanchang University (Xianghu campus) /ID# 277491
Nanchang, China
Shanghai Pulmonary Hospital /ID# 277488
Shanghai, China
Xinjiang Medical University Cancer Hospital - Urumqi /ID# 277638
Ürümqi, China
CHU Brest - Hopital de la Cavale Blanche /ID# 277883
Brest, France
CHU de Lille - Institut Coeur Poumon /ID# 276868
Lille, France
Hopital Arnaud de Villeneuve /ID# 276872
Montpellier, France
Institut Curie /ID# 277623
Paris, France
Universitaetsklinikum Heidelberg /ID# 277275
Heidelberg, Germany
Universitaetsklinikum Wuerzburg /ID# 277213
Würzburg, Germany
Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873
Marburg, Germany
Universitaetsklinikum Koeln /ID# 276862
Cologne, Germany
Universitätsklinikum Jena /ID# 277281
Jena, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 276869
Hamburg, Germany
Meir Medical Center /ID# 277289
Kefar Sava, Israel
Rabin Medical Center /ID# 276748
Petah Tikva, Israel
Yitzhak Shamir Medical Center /ID# 276750
Ẕerifin, Israel
The Chaim Sheba Medical Center /ID# 276745
Ramat Gan, Israel
Rambam Health Care Campus- Haifa /ID# 276746
Haifa, Israel
Istituto Europeo Di Oncologia /ID# 276788
Milan, Italy
AST Pesaro Urbino - Presidio Ospedaliero Santa Croce Di Fano /ID# 277338
Fano, Italy
Centro Di Riferimento Oncologico /ID# 276923
Aviano, Italy
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 277296
Rome, Italy
Ospedale Isola Tiberina - Gemelli Isola /ID# 277117
Rome, Italy
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119
Candiolo, Italy
AOU Policlinico G. Rodolico - San Marco /ID# 277265
Catania, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 277280
Verona, Italy
Hokkaido University Hospital /ID# 277240
Sapporo, Japan
Kitasato University Hospital /ID# 277241
Sagamihara-shi, Japan
National Cancer Center Hospital /ID# 277093
Chuo-Ku, Japan
Wakayama Medical University Hospital /ID# 277238
Wakayama, Japan
Radboudumc /ID# 277639
Nijmegen, Netherlands
Leids Universitair Medisch Centrum /ID# 277270
Leiden, Netherlands
Erasmus Medisch Centrum /ID# 276989
Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht /ID# 277114
Utrecht, Netherlands
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 277066
Poznan, Poland
Pratia MCM Krakow /ID# 277118
Krakow, Poland
Provita Centrum Medyczne /ID# 277494
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne /ID# 277210
Gdansk, Poland
Gyncentrum Sp. z o.o. /ID# 277522
Sosnowiec, Poland
Unidade Local de Saude do Alto Ave, EPE /ID# 277249
Guimarães, Portugal
Unidade Local de Saude de Loures-Odivelas /ID# 277223
Loures, Portugal
Unidade Local de Saude de Matosinhos EPE /ID# 277228
Senhora da Hora, Portugal
Unidade Local de Saude de Braga, EPE /ID# 277217
Braga, Portugal
Unidade Local de Saude de Santo Antonio /ID# 277216
Porto, Portugal
Hospital Cuf Porto /ID# 277225
Porto, Portugal
University Clinical Center Serbia /ID# 277051
Belgrade, Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 277052
Belgrade, Serbia
University Clinical Center Nis /ID# 277200
Niš, Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 277047
Kamenitz, Serbia
University Clinical Center Kragujevac /ID# 277162
Kragujevac, Serbia
National Cancer Center /ID# 277353
Goyang-si, South Korea
Chungbuk National University Hospital /ID# 277372
Cheongju-si, South Korea
Seoul National University Hospital /ID# 277373
Seoul, South Korea
Yonsei University Health System Severance Hospital /ID# 277394
Seoul, South Korea
Asan Medical Center /ID# 277371
Seoul, South Korea
Samsung Medical Center /ID# 277600
Seoul, South Korea
Complejo Hospitalario Universitario de Santiago /ID# 277173
Santiago de Compostela, Spain
Hospital Universitari Parc Tauli /ID# 277177
Sabadell, Spain
Hospital Universitari Vall d Hebron /ID# 277156
Barcelona, Spain
Hospital Universitario Ramon y Cajal /ID# 277153
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 277155
Madrid, Spain
Hospital Universitario Virgen de la Victoria /ID# 277159
Málaga, Spain
Hospital Clinico Universitario de Valencia /ID# 277147
Valencia, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 277154
Zaragoza, Spain
Changhua Christian Hospital /ID# 277145
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 277472
Kaohsiung City, Taiwan
Taichung Veterans General Hospital /ID# 277142
Taichung, Taiwan
Mackay Memorial Hospital /ID# 277146
Taipei, Taiwan
National Taiwan University Cancer Center (Ntucc) /ID# 277134
Taipei, Taiwan
Taipei Veterans General Hospital /ID# 277141
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 277135
Taoyuan City, Taiwan
Sakarya Universitesi Tip Fakultesi - Korucuk Kampusu /ID# 276962
Adapazarı, Turkey (Türkiye)
Adana Sehir Hastanesi /ID# 276957
Adana, Turkey (Türkiye)
Gazi University Medical Faculty /ID# 276943
Ankara, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 276961
Ankara, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276956
Istanbul, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 277063
Istanbul, Turkey (Türkiye)
Samsun Medical Park Hastanesi /ID# 277201
Samsun, Turkey (Türkiye)
St Bartholomews Hospital - Barts Health /ID# 277301
London, United Kingdom
The Christie NHS Foundation Trust - Christie Hospital /ID# 277304
Manchester, United Kingdom
Trial contact
ABBVIE CALL CENTER
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/10/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.