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Study identifier: NCT07005102 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

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

PhasePhase 2/Phase 3
Planned participants854
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 "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 doses of telisotuzumab adizutecan from from the dose escalation phase with Osi, or standard of care (Osi plus chemotherapy). In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 854 adult participants with 1L estimated glomerular filtration rate (EGFR) mut (mutated) not sufficient quantity (NSq) NSCLC will be enrolled in the study in 200 sites worldwide. In Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. participants will receive 1 of 3 doses of telisotuzumab adizutecan with Osi, or standard of care (Osi plus chemotherapy). In stage 2 pa…

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 (53)

Ironwood Cancer and Research Centers - Chandler II /ID# 275443Chandler, Arizona, United StatesRecruiting
USC Norris Comprehensive Cancer Center /ID# 275343Los Angeles, California, United StatesRecruiting
Usc Norris Oncology/Hematology Treatment Center /ID# 278673Newport Beach, California, United StatesRecruiting
University Colorado Cancer Center /ID# 275382Aurora, Colorado, United StatesRecruiting
Mid Florida Hematology And Oncology Center /ID# 275278Orange City, Florida, United StatesRecruiting
Kaiser Permanente Moanalua Medical Center /ID# 275942Honolulu, Hawaii, United StatesRecruiting
The Iowa Clinic /ID# 276020West Des Moines, Iowa, United StatesCompleted
Nho - Revive Research Institute /ID# 276115Lincoln, Nebraska, United StatesRecruiting
Renown Regional Medical Center /ID# 276049Reno, Nevada, United StatesRecruiting
Texas Oncology - South Austin /ID# 276033Austin, Texas, United StatesRecruiting
The University of Texas MD Anderson Cancer Center /ID# 275107Houston, Texas, United StatesRecruiting
Texas Oncology - Palestine Cancer Center /ID# 276034Palestine, Texas, United StatesRecruiting

+ 41 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07005102