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Study identifier: NCT06772623 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations

Condition: Non Small Cell Lung Carcinoma  ·  Sponsor: AbbVie

PhasePhase 1/Phase 2
Planned participants252
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC. Telisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 252 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan r…

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 (115)

Mayo Clinic Hospital - Phoenix /ID# 272971Phoenix, Arizona, United StatesActive Not Recruiting
Providence - St. Jude Medical Center /ID# 271414Fullerton, California, United StatesRecruiting
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450Oxnard, California, United StatesRecruiting
UCLA - Santa Monica /ID# 271690Santa Monica, California, United StatesRecruiting
University Of Colorado - Anschutz Medical Campus /ID# 269069Aurora, Colorado, United StatesRecruiting
Rocky Mountain Cancer Centers - Lone Tree /ID# 272603Lone Tree, Colorado, United StatesRecruiting
Mayo Clinic Hospital Jacksonville /ID# 275073Jacksonville, Florida, United StatesRecruiting
Mid Florida Hematology And Oncology Center /ID# 273777Orange City, Florida, United StatesRecruiting
Hope And Healing Cancer Services /ID# 276223Hinsdale, Illinois, United StatesRecruiting
Parkview Comprehensive Cancer Center /ID# 271879Fort Wayne, Indiana, United StatesRecruiting
Community Health Network /ID# 273437Indianapolis, Indiana, United StatesCompleted
Kansas City Cancer Center /ID# 273679Overland Park, Kansas, United StatesRecruiting

+ 103 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06772623