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
An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations
- Non Small Cell Lung Carcinoma
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- AbbVie
- Enrolment target
- 252
- Started
- 6 March 2025
- Main results due
- November 2027
- Study sites
- 123
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study. * Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1. * For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC. * For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration. * Must have documented programmed death ligand 1 (PD-L1) status. * For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to randomization. * Must have adequate organ function. Exclusion Criteria: * Known uncontrolled metastases to the central nervous system. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.
What this study is about
In the sponsor’s own words, from the registry.
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 reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 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.
Study sites(123)
Mayo Clinic Hospital - Phoenix /ID# 272971
Phoenix, Arizona, United States
Active, not recruiting
Providence - St. Jude Medical Center /ID# 271414
Fullerton, California, United States
Recruiting
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450
Oxnard, California, United States
Recruiting
UCLA - Santa Monica /ID# 271690
Santa Monica, California, United States
Recruiting
University Of Colorado - Anschutz Medical Campus /ID# 269069
Aurora, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers - Lone Tree /ID# 272603
Lone Tree, Colorado, United States
Recruiting
Mayo Clinic Hospital Jacksonville /ID# 275073
Jacksonville, Florida, United States
Recruiting
Mid Florida Hematology And Oncology Center /ID# 273777
Orange City, Florida, United States
Recruiting
Hope And Healing Cancer Services /ID# 276223
Hinsdale, Illinois, United States
Recruiting
Parkview Comprehensive Cancer Center /ID# 271879
Fort Wayne, Indiana, United States
Recruiting
Community Health Network /ID# 273437
Indianapolis, Indiana, United States
Completed
Kansas City Cancer Center /ID# 273679
Overland Park, Kansas, United States
Recruiting
Dana-Farber Cancer Institute /ID# 278417
Boston, Massachusetts, United States
Recruiting
Henry Ford Hospital - Detroit /ID# 271642
Detroit, Michigan, United States
Recruiting
St. Luke'S /ID# 273344
Duluth, Minnesota, United States
Recruiting
Mayo Clinic-Rochester /ID# 274512
Rochester, Minnesota, United States
Recruiting
Astera Cancer Care /ID# 271915
East Brunswick, New Jersey, United States
Recruiting
New York Cancer And Blood Specialists - Shirley /ID# 272547
Shirley, New York, United States
Recruiting
University Hospitals Cleveland Medical Center /ID# 271726
Cleveland, Ohio, United States
Completed
The Mark H Zangmeister Center /ID# 272502
Columbus, Ohio, United States
Recruiting
Spoknwrd Clinical Trials /ID# 273776
Easton, Pennsylvania, United States
Recruiting
Millennium Physicians /ID# 271717
Houston, Texas, United States
Completed
Joe Arrington Cancer Research /ID# 272776
Lubbock, Texas, United States
Recruiting
Huntsman Cancer Institute /ID# 271686
Salt Lake City, Utah, United States
Recruiting
Virgnia Cancer Specialists /ID# 269633
Leesburg, Virginia, United States
Recruiting
Vista Oncology - East Olympia /ID# 275438
Olympia, Washington, United States
Recruiting
Northwest Medical Specialties Tacoma /ID# 270469
Tacoma, Washington, United States
Recruiting
Blacktown Hospital /ID# 281588
Blacktown, New South Wales, Australia
Recruiting
Townsville University Hospital /ID# 281498
Townsville, Queensland, Australia
Recruiting
Lyell Mcewin Hospital /ID# 281860
Elizabeth Vale, South Australia, Australia
Recruiting
Peninsula University Hospital /ID# 281824
Frankston, Victoria, Australia
Recruiting
Jessa Ziekenhuis - Campus Virga Jesse /ID# 268573
Hasselt, Limburg, Belgium
Recruiting
Vitaz /Id# 280187
Sint-Niklaas, Oost-Vlaanderen, Belgium
Recruiting
AZ-Delta. /ID# 272433
Roeselare, West-Vlaanderen, Belgium
Recruiting
Groupe Sante CHC - Clinique du MontLegia /ID# 271760
Liège, Belgium
Recruiting
Cancer Hospital - Chinese Academy of Medical Sciences /ID# 269715
Beijing, Beijing Municipality, China
Recruiting
Fujian Province Cancer Hospital /ID# 269150
Fuzhou, Fujian, China
Recruiting
Liuzhou People's hospital /ID# 269667
Liuzhou, Guangxi, China
Recruiting
Henan Cancer Hospital /ID# 269668
Zhengzhou, Henan, China
Recruiting
Union Hospital - Tongji Medical College /ID# 272286
Wuhan, Hubei, China
Recruiting
Hunan Province Cancer Hospital /ID# 269679
Changsha, Hunan, China
Recruiting
Nanjing Drum Tower Hospital /ID# 269762
Nanjing, Jiangsu, China
Recruiting
The First Affiliated Hospital of Nanchang University /ID# 269190
Nanchang, Jiangxi, China
Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271904
Xi'an, Shaanxi, China
Recruiting
Shanghai Chest Hospital /ID# 269155
Shanghai, Shanghai Municipality, China
Recruiting
Shanghai Pulmonary Hospital /ID# 276397
Shanghai, Shanghai Municipality, China
Recruiting
First Affiliated Hospital of Shanxi Medical University /ID# 276482
Taiyuan, Shanxi, China
Recruiting
Sichuan Cancer Hospital /ID# 269712
Chengdu, Sichuan, China
Recruiting
West China Hospital of Sichuan University /ID# 270244
Chengdu, Sichuan, China
Recruiting
Yunnan Province Cancer Hospital /ID# 272331
Kunming, Yunnan, China
Recruiting
Institut Bergonie /ID# 258377
Bordeaux, Gironde, France
Recruiting
CHU Nantes - Hopital Laennec /ID# 268475
Saint-Herblain, Loire-Atlantique, France
Recruiting
Institut de Cancerologie de l'Ouest Rene Gauducheau /ID# 268484
Saint-Herblain, Loire-Atlantique, France
Recruiting
Centre De Cancerologie Du Grand Montpellier /ID# 273724
Montpellier, Occitanie, France
Recruiting
Centre Antoine-Lacassagne /ID# 268486
Nice, Provence-Alpes-Côte d'Azur Region, France
Recruiting
Institut Gustave Roussy /ID# 258373
Villejuif, Val-de-Marne, France
Recruiting
Institut Curie /ID# 271395
Paris, Île-de-France Region, France
Recruiting
Universitaetsklinikum Freiburg /ID# 268473
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Recruiting
Slk-Kliniken Heilbronn /ID# 269621
Heilbronn, Baden-Wurttemberg, Germany
Recruiting
Hamatologie-Onkologie im Zentrum MVZ GmbH /ID# 273043
Augsburg, Bavaria, Germany
Recruiting
Showing 60 of 123 sites — filter to narrow it down. 119 of the 123 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06772623. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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