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
NCT ID: NCT06772623
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
252 participants
INTERVENTIONAL
2025-03-06
2027-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Telisotuzumab Adizutecan + Budigalimab
Participants will receive several doses of telisotuzumab adizutecan in combination with budigalimab, as part of the 33 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Budigalimab
IV Infusion
Part 2 Arm 1: Telisotuzumab Adizutecan + Pembrolizumab
Participants will receive telisotuzumab adizutecan dose A in combination with pembrolizumab, as part of the 33 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Pembrolizumab
IV Injection
Part 2 Arm 2: Telisotuzumab Adizutecan + Pembrolizumab
Participants will receive telisotuzumab adizutecan dose B in combination with pembrolizumab, as part of the 33 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Pembrolizumab
IV Injection
Part 2: Standard of Care
Participants will receive pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed, as part of the 33 month study duration.
Pembrolizumab
IV Injection
Pembrolizumab
IV Infusion
Carboplatin
IV Infusion
Pemetrexed
IV Infusion
Cisplatin
IV Infusion
Interventions
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Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Budigalimab
IV Infusion
Pembrolizumab
IV Injection
Pembrolizumab
IV Infusion
Carboplatin
IV Infusion
Pemetrexed
IV Infusion
Cisplatin
IV Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Providence - St. Jude Medical Center /ID# 271414
Fullerton, California, United States
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450
Oxnard, California, United States
University Of Colorado - Anschutz Medical Campus /ID# 269069
Aurora, Colorado, United States
Rocky Mountain Cancer Centers - Lone Tree /ID# 272603
Lone Tree, Colorado, United States
Mid Florida Hematology And Oncology Center /ID# 273777
Orange City, Florida, United States
Hope And Healing Cancer Services /ID# 276223
Hinsdale, Illinois, United States
Community Health Network /ID# 273437
Indianapolis, Indiana, United States
Astera Cancer Care /ID# 271915
East Brunswick, New Jersey, United States
New York Cancer and Blood Specialists - New York /ID# 272547
New York, New York, United States
University Hospitals Cleveland Medical Center /ID# 271726
Cleveland, Ohio, United States
The Mark H Zangmeister Center /ID# 272502
Columbus, Ohio, United States
Spoknwrd Clinical Trials /ID# 273776
Easton, Pennsylvania, United States
Millennium Research & Clinical Development /ID# 271717
Houston, Texas, United States
Huntsman Cancer Institute /ID# 271686
Salt Lake City, Utah, United States
Vista Oncology - East Olympia /ID# 275438
Olympia, Washington, United States
Northwest Medical Specialties Tacoma /ID# 270469
Tacoma, Washington, United States
Groupe Sante CHC - Clinique du MontLegia /ID# 271760
Liège, Liege, Belgium
AZ-Delta /ID# 272433
Roeselare, West-Vlaanderen, Belgium
CHU Nantes - Hopital Laennec /ID# 268475
Saint-Herblain, Loire-Atlantique, France
Centre Antoine-Lacassagne /ID# 268486
Nice, Provence-Alpes-Côte d'Azur Region, France
Institut Gustave Roussy /ID# 258373
Villejuif, Val-de-Marne, France
Universitaetsklinikum Freiburg /ID# 268473
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsklinikum Frankfurt /ID# 268721
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Koeln /ID# 268489
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Jena /ID# 269700
Jena, Thuringia, Germany
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 268684
Meldola, Forlì-Cesena, Italy
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 268626
Rome, Roma, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 268675
Bologna, , Italy
NHO Nagoya Medical Center /ID# 272515
Nagoya, Aichi-ken, Japan
Aichi Cancer Center /ID# 271978
Nagoya, Aichi-ken, Japan
Yokohama Municipal Citizen's Hospital /ID# 271979
Yokohama, Kanagawa, Japan
Kyoto University Hospital /ID# 272312
Kyoto, Kyoto, Japan
Osaka Medical And Pharmaceutical University Hospital /ID# 273309
Takatsuki, Osaka, Japan
National Cancer Center Hospital /ID# 273192
Chuo-Ku, Tokyo, Japan
Pan American Center for Oncology Trials /ID# 268827
Rio Piedras, , Puerto Rico
Complejo Hospitalario Universitario A Coruña /ID# 271456
A Coruña, A Coruna, Spain
Hospital Universitario Marques de Valdecilla /ID# 271314
Santander, Cantabria, Spain
Hospital Universitario Virgen de la Victoria /ID# 271312
Málaga, Malaga, Spain
Hospital Universitario Virgen Macarena /ID# 271447
Seville, Sevilla, Spain
Hospital General Universitario de Alicante Doctor Balmis /ID# 271316
Alicante, , Spain
Parc de Salut Mar - Hospital del Mar /ID# 271310
Barcelona, , Spain
Hospital Clinic de Barcelona /ID# 271452
Barcelona, , Spain
Hospital Santa Creu i Sant Pau /ID# 271311
Barcelona, , Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 268138
Kaohsiung City, Kaohsiung, Taiwan
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 268789
Chiayi City, , Taiwan
National Taiwan University Cancer Center (Ntucc) /ID# 271586
Taipei, , Taiwan
Taipei Veterans General Hospital /ID# 268787
Taipei, , Taiwan
Tri-Service General Hospital /ID# 269211
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 268137
Taoyuan, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2024-514465-18
Identifier Type: OTHER
Identifier Source: secondary_id
M24-536
Identifier Type: -
Identifier Source: org_study_id
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