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A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Sponsor: AbbVie
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 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. 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 430 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. 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.
Official title: Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
430
Start Date
2025-12-10
Completion Date
2030-09
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Standard of Care
Standard of Care
Locations (53)
Highlands Oncology Group - Springdale /ID# 277132
Springdale, Arkansas, United States
Cancer Care Centers of Brevard- Rockledge /ID# 277853
Rockledge, Florida, United States
HealthPartners Cancer Research Center /ID# 277339
Saint Louis Park, Minnesota, United States
Nho - Revive Research Institute /ID# 277569
Lincoln, Nebraska, United States
Astera Cancer Care /ID# 277570
East Brunswick, New Jersey, United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
Knoxville, Tennessee, United States
SCRI Oncology Partners /ID# 276959
Nashville, Tennessee, United States
Northwest Cancer Specialists - Vancouver /ID# 277855
Vancouver, Washington, United States
Canberra Hospital /ID# 277166
Garran, Australian Capital Territory, Australia
St George Hospital /ID# 277168
Kogarah, New South Wales, Australia
Mater Hospital Brisbane /ID# 276985
South Brisbane, Queensland, Australia
Icon Cancer Centre Hobart /ID# 277549
Hobart, Tasmania, Australia
St Vincent's Hospital Melbourne /ID# 277002
Fitzroy, Victoria, Australia
Sunshine Hospital /ID# 276894
St Albans, Victoria, Australia
One Clinical Research - Nedlands /ID# 277598
Nedlands, Western Australia, Australia
Klinik Floridsdorf /ID# 276679
Vienna, Vienna, Austria
Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202
Hasselt, Limburg, Belgium
Universitair Ziekenhuis Leuven /ID# 276874
Leuven, Vlaams-Brabant, Belgium
Guangdong Provincial People'S Hospital /ID# 277631
Guangzhou, Guangdong, China
Universitaetsklinikum Heidelberg /ID# 277275
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Wuerzburg /ID# 277213
Würzburg, Bavaria, Germany
Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873
Marburg, Hesse, Germany
Universitaetsklinikum Koeln /ID# 276862
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Jena /ID# 277281
Jena, Thuringia, Germany
Meir Medical Center /ID# 277289
Kfar Saba, Central District, Israel
Rabin Medical Center /ID# 276748
Petah Tikva, Central District, Israel
Yitzhak Shamir Medical Center /ID# 276750
Ẕerifin, Central District, Israel
The Chaim Sheba Medical Center /ID# 276745
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 276746
Haifa, Israel
Ospedale Isola Tiberina - Gemelli Isola /ID# 277117
Rome, Roma, Italy
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119
Candiolo, Torino, Italy
Hokkaido University Hospital /ID# 277240
Sapporo, Hokkaido, Japan
Kitasato University Hospital /ID# 277241
Sagamihara-shi, Kanagawa, Japan
National Cancer Center Hospital /ID# 277093
Chuo-Ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 277238
Wakayama, Wakayama, Japan
Unidade Local de Saude do Alto Ave, EPE /ID# 277249
Guimarães, Braga District, Portugal
Unidade Local de Saude de Loures-Odivelas, EPE /ID# 277223
Loures, Lisbon District, Portugal
Unidade Local de Saude de Matosinhos, EPE /ID# 277228
Senhora da Hora, Porto District, Portugal
Unidade Local de Saude de Braga, EPE /ID# 277217
Braga, Portugal
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 277216
Porto, Portugal
National Cancer Center /ID# 277353
Goyang-si, Gyeonggido, South Korea
Chungbuk National University Hospital /ID# 277372
Cheongju-si, North Chungcheong, South Korea
Seoul National University Hospital /ID# 277373
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 277371
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 277600
Seoul, Seoul Teugbyeolsi, South Korea
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
Taichung Veterans General Hospital /ID# 277142
Taichung, Taiwan
Mackay Memorial Hospital /ID# 277146
Taipei, Taiwan
Taipei Veterans General Hospital /ID# 277141
Taipei, Taiwan