Actively 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
Led by AbbVie · Updated on 2026-05-13
252
Participants Needed
64
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-squamous non small cell lung carcinoma that is locally advanced or metastatic
- Measurable disease based on RECIST v1.1 criteria
- For Part 1: No more than one prior systemic therapy for advanced disease including platinum-based chemotherapy, immune checkpoint inhibitor, or appropriate targeted therapy for actionable gene alteration if applicable
- For Part 2: No prior systemic therapy for advanced disease and no known actionable genomic alterations
- Documented programmed death ligand 1 (PD-L1) status
- For Part 2: Evaluable c-Met immunohistochemistry result from central testing before randomization
- Adequate organ function
You will not qualify if you...
- Known uncontrolled metastases to the central nervous system
- History of interstitial lung disease or pneumonitis requiring systemic steroids treatment, or any active interstitial lung disease or pneumonitis on screening chest CT scan
AI-Screening
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Trial Site Locations
Total: 64 locations
1
Providence - St. Jude Medical Center /ID# 271414
Fullerton, California, United States, 92835
Actively Recruiting
2
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450
Oxnard, California, United States, 93030
Actively Recruiting
3
UCLA - Santa Monica /ID# 271690
Santa Monica, California, United States, 90404
Actively Recruiting
4
University Of Colorado - Anschutz Medical Campus /ID# 269069
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Rocky Mountain Cancer Centers - Lone Tree /ID# 272603
Lone Tree, Colorado, United States, 80124
Actively Recruiting
6
Mid Florida Hematology And Oncology Center /ID# 273777
Orange City, Florida, United States, 32763
Actively Recruiting
7
Hope And Healing Cancer Services /ID# 276223
Hinsdale, Illinois, United States, 60521
Actively Recruiting
8
Community Health Network /ID# 273437
Indianapolis, Indiana, United States, 46202
Actively Recruiting
9
Kansas City Cancer Center /ID# 273679
Overland Park, Kansas, United States, 66210
Actively Recruiting
10
Astera Cancer Care /ID# 271915
East Brunswick, New Jersey, United States, 08816-4096
Actively Recruiting
11
New York Cancer And Blood Specialists - Shirley /ID# 272547
Shirley, New York, United States, 11967
Actively Recruiting
12
University Hospitals Cleveland Medical Center /ID# 271726
Cleveland, Ohio, United States, 44106
Actively Recruiting
13
The Mark H Zangmeister Center /ID# 272502
Columbus, Ohio, United States, 43219
Actively Recruiting
14
Spoknwrd Clinical Trials /ID# 273776
Easton, Pennsylvania, United States, 18045
Actively Recruiting
15
Millennium Physicians /ID# 271717
Houston, Texas, United States, 77090
Completed
16
Joe Arrington Cancer Research /ID# 272776
Lubbock, Texas, United States, 79410-1121
Actively Recruiting
17
Huntsman Cancer Institute /ID# 271686
Salt Lake City, Utah, United States, 84112
Actively Recruiting
18
Virgnia Cancer Specialists /ID# 269633
Leesburg, Virginia, United States, 20176
Actively Recruiting
19
Vista Oncology - East Olympia /ID# 275438
Olympia, Washington, United States, 98506
Actively Recruiting
20
Northwest Medical Specialties Tacoma /ID# 270469
Tacoma, Washington, United States, 98405
Actively Recruiting
21
Groupe Sante CHC - Clinique du MontLegia /ID# 271760
Liège, Liege, Belgium, 4000
Actively Recruiting
22
AZ-Delta. /ID# 272433
Roeselare, West-Vlaanderen, Belgium, 8800
Actively Recruiting
23
Liuzhou People's hospital /ID# 269667
Liuzhou, Guangxi, China, 545006
Actively Recruiting
24
CHU Nantes - Hopital Laennec /ID# 268475
Saint-Herblain, Loire-Atlantique, France, 44800
Actively Recruiting
25
Centre Antoine-Lacassagne /ID# 268486
Nice, Provence-Alpes-Côte d'Azur Region, France, 06189
Actively Recruiting
26
Institut Gustave Roussy /ID# 258373
Villejuif, Val-de-Marne, France, 94805
Actively Recruiting
27
Universitaetsklinikum Freiburg /ID# 268473
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
28
Universitaetsklinikum Frankfurt /ID# 268721
Frankfurt am Main, Hesse, Germany, 60590
Actively Recruiting
29
Universitaetsklinikum Koeln /ID# 268489
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
30
Universitätsklinikum Jena /ID# 269700
Jena, Thuringia, Germany, 07747
Actively Recruiting
31
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 268684
Meldola, Forlì-Cesena, Italy, 47014
Actively Recruiting
32
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 268626
Rome, Roma, Italy, 00144
Actively Recruiting
33
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 268675
Bologna, Italy, 40138
Actively Recruiting
34
NHO Nagoya Medical Center /ID# 272515
Nagoya, Aichi-ken, Japan, 460-0001
Actively Recruiting
35
Aichi Cancer Center /ID# 271978
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
36
Hirosaki University Hospital /ID# 274410
Hirosaki, Aomori, Japan, 036-8563
Actively Recruiting
37
Yokohama Municipal Citizen's Hospital /ID# 271979
Yokohama, Kanagawa, Japan, 221-0855
Actively Recruiting
38
Kyoto University Hospital /ID# 272312
Kyoto, Kyoto, Japan, 606-8507
Actively Recruiting
39
Niigata University Medical & Dental Hospital /ID# 274448
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
40
Osaka Medical And Pharmaceutical University Hospital /ID# 273309
Takatsuki, Osaka, Japan, 569-8686
Actively Recruiting
41
National Cancer Center Hospital /ID# 273192
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
42
The Cancer Institute Hospital Of JFCR /ID# 271989
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
43
Nagasaki University Hospital /ID# 273310
Nagasaki, Japan, 852-8501
Actively Recruiting
44
Pan American Center for Oncology Trials /ID# 268827
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
45
Complejo Hospitalario Universitario A Coruña /ID# 271456
A Coruña, A Coruna, Spain, 15006
Actively Recruiting
46
Hospital Universitario Marques de Valdecilla /ID# 271314
Santander, Cantabria, Spain, 39008
Actively Recruiting
47
Hospital Universitario Virgen Macarena /ID# 271447
Seville, Sevilla, Spain, 41009
Actively Recruiting
48
Hospital General Universitario de Alicante Doctor Balmis /ID# 271316
Alicante, Spain, 03010
Actively Recruiting
49
Parc de Salut Mar - Hospital del Mar /ID# 271310
Barcelona, Spain, 08003
Actively Recruiting
50
Hospital Clinic de Barcelona /ID# 271452
Barcelona, Spain, 08036
Actively Recruiting
51
Hospital Santa Creu i Sant Pau /ID# 271311
Barcelona, Spain, 08041
Actively Recruiting
52
Hospital Universitario Virgen de la Victoria /ID# 271312
Málaga, Spain, 29010
Actively Recruiting
53
Kaohsiung Chang Gung Memorial Hospital /ID# 268138
Kaohsiung City, Kaohsiung, Taiwan, 833
Actively Recruiting
54
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 268789
Chiayi City, Taiwan, 62247
Actively Recruiting
55
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 268139
Kaohsiung City, Taiwan, 807
Actively Recruiting
56
National Taiwan University Cancer Center (Ntucc) /ID# 271586
Taipei, Taiwan, 106
Actively Recruiting
57
Taipei Veterans General Hospital /ID# 268787
Taipei, Taiwan, 112
Actively Recruiting
58
Tri-Service General Hospital /ID# 269211
Taipei, Taiwan, 114
Actively Recruiting
59
Linkou Chang Gung Memorial Hospital /ID# 268137
Taoyuan City, Taiwan, 333
Actively Recruiting
60
Sakarya Egitim ve Arastirma Hastanesi /ID# 272878
Adapazarı, Sakarya, Turkey (Türkiye), 54290
Actively Recruiting
61
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 272873
Ankara, Turkey (Türkiye), 06620
Actively Recruiting
62
Pamukkale Universitesi /ID# 272893
Denizli, Turkey (Türkiye), 20070
Actively Recruiting
63
Necmettin Erbakan Üniversitesi Meram Tip Fakültesi - Eski Hastane /ID# 272882
Konya, Turkey (Türkiye), 42080
Actively Recruiting
64
Ondokuz Mayis Universitesi /ID# 272899
Samsun, Turkey (Türkiye), 55139
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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