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
3 other identifiers
interventional
252
14 countries
117
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2025
Typical duration for phase_1
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2025
CompletedFirst Posted
Study publicly available on registry
January 13, 2025
CompletedStudy Start
First participant enrolled
March 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
July 31, 2026
July 1, 2026
2.7 years
January 9, 2025
July 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Part 1: Dose-Limiting Toxicities (DLT)s of Telisotuzumab Adizutecan
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Up to Approximately 84 Days
Part 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) per BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Up to Approximately 33 Months
Number of Participants with Adverse Events (AE)s
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to Approximately 33 Months
Secondary Outcomes (9)
Part 1 and Part 2: PFS as Assessed by Investigator
Up to Approximately 33 Months
Part 1 and Part 2: DOR as Assessed by Investigator
Up to Approximately 33 Months
Part 1 and Part 2: DC as Assessed by Investigator
Up to Approximately 33 Months
Part 1 and Part 2: Overall Survival (OS)
Up to Approximately 33 Months
Programmed Death Ligand 1 (PD-L1) and c-Met Subgroups: OR
Up to Approximately 33 Months
- +4 more secondary outcomes
Study Arms (4)
Part 1: Telisotuzumab Adizutecan + Budigalimab
EXPERIMENTALParticipants will receive several doses of telisotuzumab adizutecan in combination with budigalimab, as part of the 33 month study duration.
Part 2 Arm 1: Telisotuzumab Adizutecan + Pembrolizumab
EXPERIMENTALParticipants will receive telisotuzumab adizutecan dose A in combination with pembrolizumab, as part of the 33 month study duration.
Part 2 Arm 2: Telisotuzumab Adizutecan + Pembrolizumab
EXPERIMENTALParticipants will receive telisotuzumab adizutecan dose B in combination with pembrolizumab, as part of the 33 month study duration.
Part 2: Standard of Care
EXPERIMENTALParticipants 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.
Interventions
Intravenous (IV) Infusion
IV Injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (117)
Mayo Clinic Hospital - Phoenix /ID# 272971
Phoenix, Arizona, 85054, United States
Providence - St. Jude Medical Center /ID# 271414
Fullerton, California, 92835, United States
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450
Oxnard, California, 93030, United States
UCLA - Santa Monica /ID# 271690
Santa Monica, California, 90404, United States
University Of Colorado - Anschutz Medical Campus /ID# 269069
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers - Lone Tree /ID# 272603
Lone Tree, Colorado, 80124, United States
Mayo Clinic Hospital Jacksonville /ID# 275073
Jacksonville, Florida, 32224, United States
Mid Florida Hematology And Oncology Center /ID# 273777
Orange City, Florida, 32763, United States
Hope And Healing Cancer Services /ID# 276223
Hinsdale, Illinois, 60521, United States
Parkview Comprehensive Cancer Center /ID# 271879
Fort Wayne, Indiana, 46845, United States
Community Health Network /ID# 273437
Indianapolis, Indiana, 46202, United States
Kansas City Cancer Center /ID# 273679
Overland Park, Kansas, 66210, United States
Dana-Farber Cancer Institute /ID# 278417
Boston, Massachusetts, 02215, United States
Henry Ford Hospital /ID# 271642
Detroit, Michigan, 48202, United States
St. Luke'S /ID# 273344
Duluth, Minnesota, 55805, United States
Mayo Clinic-Rochester /ID# 274512
Rochester, Minnesota, 55905, United States
Astera Cancer Care /ID# 271915
East Brunswick, New Jersey, 08816-4096, United States
New York Cancer And Blood Specialists - Shirley /ID# 272547
Shirley, New York, 11967, United States
University Hospitals Cleveland Medical Center /ID# 271726
Cleveland, Ohio, 44106, United States
The Mark H Zangmeister Center /ID# 272502
Columbus, Ohio, 43219, United States
Spoknwrd Clinical Trials /ID# 273776
Easton, Pennsylvania, 18045, United States
Millennium Physicians /ID# 271717
Houston, Texas, 77090, United States
Joe Arrington Cancer Research /ID# 272776
Lubbock, Texas, 79410-1121, United States
Huntsman Cancer Institute /ID# 271686
Salt Lake City, Utah, 84112, United States
Virgnia Cancer Specialists /ID# 269633
Leesburg, Virginia, 20176, United States
Vista Oncology - East Olympia /ID# 275438
Olympia, Washington, 98506, United States
Northwest Medical Specialties Tacoma /ID# 270469
Tacoma, Washington, 98405, United States
Groupe Sante CHC - Clinique du MontLegia /ID# 271760
Liège, Liege, 4000, Belgium
Jessa Ziekenhuis - Campus Virga Jesse /ID# 268573
Hasselt, Limburg, 3500, Belgium
Vitaz /Id# 280187
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
AZ-Delta. /ID# 272433
Roeselare, West-Vlaanderen, 8800, Belgium
Cancer Hospital - Chinese Academy of Medical Sciences /ID# 269715
Beijing, Beijing Municipality, 100021, China
Fujian Province Cancer Hospital /ID# 269150
Fuzhou, Fujian, 350014, China
Liuzhou People's hospital /ID# 269667
Liuzhou, Guangxi, 545006, China
Henan Cancer Hospital /ID# 269668
Zhengzhou, Henan, 450008, China
Union Hospital - Tongji Medical College /ID# 272286
Wuhan, Hubei, 430022, China
Hunan Province Cancer Hospital /ID# 269679
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital /ID# 269762
Nanjing, Jiangsu, 210008, China
The First Affiliated Hospital of Nanchang University /ID# 269190
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271904
Xi'an, Shaanxi, 710061, China
Shanghai Chest Hospital /ID# 269155
Shanghai, Shanghai Municipality, 200030, China
Shanghai Pulmonary Hospital /ID# 276397
Shanghai, Shanghai Municipality, 200433, China
First Affiliated Hospital of Shanxi Medical University /ID# 276482
Taiyuan, Shanxi, 030001, China
Sichuan Cancer Hospital /ID# 269712
Chengdu, Sichuan, 610041, China
West China Hospital of Sichuan University /ID# 270244
Chengdu, Sichuan, 610041, China
Yunnan Province Cancer Hospital /ID# 272331
Kunming, Yunnan, 650106, China
Institut Bergonie /ID# 258377
Bordeaux, Gironde, 33000, France
CHU Nantes - Hopital Laennec /ID# 268475
Saint-Herblain, Loire-Atlantique, 44800, France
Institut de Cancerologie de l'Ouest Rene Gauducheau /ID# 268484
Saint-Herblain, Loire-Atlantique, 44805, France
Centre De Cancerologie Du Grand Montpellier /ID# 273724
Montpellier, Occitanie, 34070, France
Centre Antoine-Lacassagne /ID# 268486
Nice, Provence-Alpes-Côte d'Azur Region, 06189, France
Institut Gustave Roussy /ID# 258373
Villejuif, Val-de-Marne, 94805, France
Institut Curie /ID# 271395
Paris, Île-de-France Region, 75248, France
Universitaetsklinikum Freiburg /ID# 268473
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Slk-Kliniken Heilbronn /ID# 269621
Heilbronn, Baden-Wurttemberg, 74078, Germany
Hamatologie-Onkologie im Zentrum MVZ GmbH /ID# 273043
Augsburg, Bavaria, 86150, Germany
Universitaetsklinikum Wuerzburg /ID# 275445
Würzburg, Bavaria, 97080, Germany
Universitaetsklinikum Frankfurt /ID# 268721
Frankfurt am Main, Hesse, 60590, Germany
Universitaetsklinikum Koeln /ID# 268489
Cologne, North Rhine-Westphalia, 50937, Germany
Lungenklinik Hemer /ID# 269779
Hemer, North Rhine-Westphalia, 58675, Germany
ohO Research GmbH /ID# 273060
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Universitatsklinikum Jena /ID# 269700
Jena, Thuringia, 07747, Germany
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 268684
Meldola, Forlì-Cesena, 47014, Italy
Istituto Europeo Di Oncologia /Id# 268670
Milan, Milano, 20121, Italy
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 268626
Rome, Roma, 00144, Italy
Azienda Ospedaliera Complesso Ospedaliero San Giovanni-Addolorata /ID# 273438
Rome, Roma, 00184, Italy
Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 268641
Orbassano, Torino, 10043, Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 268667
Ancona, 60126, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 268675
Bologna, 40138, Italy
NHO Nagoya Medical Center /ID# 272515
Nagoya, Aichi-ken, 460-0001, Japan
Aichi Cancer Center /ID# 271978
Nagoya, Aichi-ken, 464-8681, Japan
Hirosaki University Hospital /ID# 274410
Hirosaki, Aomori, 036-8563, Japan
Yokohama Municipal Citizen's Hospital /ID# 271979
Yokohama, Kanagawa, 221-0855, Japan
Kyoto University Hospital /ID# 272312
Kyoto, Kyoto, 606-8507, Japan
Niigata University Medical and Dental Hospital /ID# 274448
Niigata, Niigata, 951-8520, Japan
Osaka Medical And Pharmaceutical University Hospital /ID# 273309
Takatsuki, Osaka, 569-8686, Japan
National Cancer Center Hospital /ID# 273192
Chuo-Ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital Of JFCR /ID# 271989
Koto-ku, Tokyo, 135-8550, Japan
Nagasaki University Hospital /ID# 273310
Nagasaki, 852-8501, Japan
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 273170
Lublin, Lublin Voivodeship, 20-090, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 276848
Bialystok, Podlaskie Voivodeship, 15-540, Poland
Uniwersyteckie Centrum Kliniczne /ID# 272418
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 274549
Kielce, Świętokrzyskie Voivodeship, 25-734, Poland
Pan American Center for Oncology Trials - Rio Piedras /ID# 268827
Rio Piedras, 00935, Puerto Rico
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca /ID# 268725
Cluj-Napoca, Cluj, 400015, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca /ID# 273125
Cluj-Napoca, Cluj, 400015, Romania
S.C. Radiotherapy Center Cluj SRL /ID# 268729
Cluj-Napoca, Cluj, 400080, Romania
MNT Healthcare Europe SRL /ID# 269075
Bucharest, 013975, Romania
Clinica MedLife Polisano Sibiu /ID# 269078
Sibiu, 550253, Romania
Hospital Universitario Marques de Valdecilla /ID# 271314
Santander, Cantabria, 39008, Spain
Hospital Universitario Virgen Macarena /ID# 271447
Seville, Sevilla, 41009, Spain
Complejo Hospitalario Universitario A Coruna /ID# 271456
A Coruña, 15006, Spain
Hospital General Universitario de Alicante Doctor Balmis /ID# 271316
Alicante, 03010, Spain
Parc de Salut Mar - Hospital del Mar /ID# 271310
Barcelona, 08003, Spain
Hospital Clinic de Barcelona /ID# 271452
Barcelona, 08036, Spain
Hospital Santa Creu i Sant Pau /ID# 271311
Barcelona, 08041, Spain
Hospital Universitario Virgen de la Victoria /ID# 271312
Málaga, 29010, Spain
Changhua Christian Hospital /ID# 280139
Changhua, 500, Taiwan
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 268789
Chiayi City, 62247, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 268139
Kaohsiung City, 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 268138
Kaohsiung City, 833, Taiwan
National Taiwan University Cancer Center (Ntucc) /ID# 271586
Taipei, 106, Taiwan
Taipei Veterans General Hospital /ID# 268787
Taipei, 112, Taiwan
Tri-Service General Hospital /ID# 269211
Taipei, 114, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 268137
Taoyuan City, 333, Taiwan
Gulhane Egitim ve Arastirma Hastanesi /ID# 280715
Ankara, Antalya, 06010, Turkey (Türkiye)
Sakarya Egitim ve Arastirma Hastanesi /ID# 272878
Adapazarı, Sakarya, 54290, Turkey (Türkiye)
Adana Medical Park Seyhan Hastanesi /ID# 272875
Adana, 01140, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 272873
Ankara, 06620, Turkey (Türkiye)
Liv Hospital Ankara /ID# 272876
Ankara, 06680, Turkey (Türkiye)
Pamukkale Universitesi /ID# 272893
Denizli, 20070, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 280635
Istanbul, 34722, Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi - Eski Hastane /ID# 272882
Konya, 42080, Turkey (Türkiye)
Ondokuz Mayis Universitesi /ID# 272899
Samsun, 55139, Turkey (Türkiye)
Samsun Medical Park Hastanesi /ID# 272880
Samsun, 55200, Turkey (Türkiye)
Leicester Royal Infirmary /ID# 276035
Leicester, Leicestershire, LE1 5WW, United Kingdom
Velindre Cancer Centre /ID# 271840
Cardiff, CF14 2TL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2025
First Posted
January 13, 2025
Study Start
March 6, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.