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Study identifier: NCT07155187 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Non-Small Cell Lung Cancer  ·  Sponsor: AbbVie

PhasePhase 2/Phase 3
Planned participants490
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 an…

This description comes directly from the study's public registry record.

Talk to the study team

ABBVIE CALL CENTER  ·  844-663-3742  ·  abbvieclinicaltrials@abbvie.com

Always discuss trial participation with your own doctor first.

Locations (110)

Highlands Oncology Group - Springdale /ID# 277132Springdale, Arkansas, United StatesRecruiting
City of Hope National Medical Center /ID# 277005Duarte, California, United StatesRecruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928Irvine, California, United StatesRecruiting
Cancer Specialists of North Florida /ID# 277332Jacksonville, Florida, United StatesRecruiting
Cancer Care Centers of Brevard- Rockledge /ID# 277853Rockledge, Florida, United StatesRecruiting
Moffitt Cancer Center /ID# 276785Tampa, Florida, United StatesRecruiting
Parkview Research Center /ID# 277651Fort Wayne, Indiana, United StatesRecruiting
HealthPartners Cancer Research Center /ID# 277339Saint Louis Park, Minnesota, United StatesRecruiting
Nho - Revive Research Institute /ID# 277569Lincoln, Nebraska, United StatesRecruiting
Dartmouth-Hitchcock Medical Center /ID# 277673Lebanon, New Hampshire, United StatesRecruiting
Astera Cancer Care /ID# 277570East Brunswick, New Jersey, United StatesRecruiting
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891Knoxville, Tennessee, United StatesRecruiting

+ 98 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07155187