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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT06772623

Registry updated: 2026-10-20
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Description

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.

Interventions

  • Telisotuzumab Adizutecan (Drug)
    Intravenous (IV) Infusion
  • Budigalimab (Drug)
    IV Infusion
  • Pembrolizumab (Drug)
    IV Injection
  • Pembrolizumab (Drug)
    IV Infusion
  • Carboplatin (Drug)
    IV Infusion
  • Pemetrexed (Drug)
    IV Infusion
  • Cisplatin (Drug)
    IV Infusion

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.

Conditions

Non Small Cell Lung Carcinoma c-MET

Locations

  • Mayo Clinic Hospital - Phoenix /ID# 272971 — Phoenix, Arizona, United States
  • 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
  • UCLA - Santa Monica /ID# 271690 — Santa Monica, 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
  • Mayo Clinic Hospital Jacksonville /ID# 275073 — Jacksonville, Florida, 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
  • Parkview Comprehensive Cancer Center /ID# 271879 — Fort Wayne, Indiana, United States
  • Community Health Network /ID# 273437 — Indianapolis, Indiana, United States
  • Kansas City Cancer Center /ID# 273679 — Overland Park, Kansas, United States
  • Dana-Farber Cancer Institute /ID# 278417 — Boston, Massachusetts, United States
  • Henry Ford Hospital - Detroit /ID# 271642 — Detroit, Michigan, United States
  • St. Luke'S /ID# 273344 — Duluth, Minnesota, United States
  • Mayo Clinic-Rochester /ID# 274512 — Rochester, Minnesota, United States
  • Astera Cancer Care /ID# 271915 — East Brunswick, New Jersey, United States
  • New York Cancer And Blood Specialists - Shirley /ID# 272547 — Shirley, 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 Physicians /ID# 271717 — Houston, Texas, United States
  • Joe Arrington Cancer Research /ID# 272776 — Lubbock, Texas, United States
  • Huntsman Cancer Institute /ID# 271686 — Salt Lake City, Utah, United States
  • Virgnia Cancer Specialists /ID# 269633 — Leesburg, Virginia, United States
  • Vista Oncology - East Olympia /ID# 275438 — Olympia, Washington, United States
  • Northwest Medical Specialties Tacoma /ID# 270469 — Tacoma, Washington, United States
  • Instituto Alexander Fleming /ID# 282704 — Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
  • Centro Oncologico Korben /ID# 281460 — Buenos Aires, Argentina
  • Fundacion Respirar /ID# 281039 — Buenos Aires, Argentina
  • Blacktown Hospital /ID# 281588 — Blacktown, New South Wales, Australia
  • Townsville University Hospital /ID# 281498 — Townsville, Queensland, Australia
  • Lyell Mcewin Hospital /ID# 281860 — Elizabeth Vale, South Australia, Australia
  • Peninsula University Hospital /ID# 281824 — Frankston, Victoria, Australia
  • Jessa Ziekenhuis - Campus Virga Jesse /ID# 268573 — Hasselt, Limburg, Belgium
  • Vitaz /Id# 280187 — Sint-Niklaas, Oost-Vlaanderen, Belgium
  • AZ-Delta. /ID# 272433 — Roeselare, West-Vlaanderen, Belgium
  • Groupe Sante CHC - Clinique du MontLegia /ID# 271760 — Liège, Belgium
  • Cancer Hospital - Chinese Academy of Medical Sciences /ID# 269715 — Beijing, Beijing Municipality, China
  • Fujian Province Cancer Hospital /ID# 269150 — Fuzhou, Fujian, China
  • Liuzhou People's hospital /ID# 269667 — Liuzhou, Guangxi, China
  • Henan Cancer Hospital /ID# 269668 — Zhengzhou, Henan, China
  • Union Hospital - Tongji Medical College /ID# 272286 — Wuhan, Hubei, China
  • Hunan Province Cancer Hospital /ID# 269679 — Changsha, Hunan, China
  • Nanjing Drum Tower Hospital /ID# 269762 — Nanjing, Jiangsu, China
  • The First Affiliated Hospital of Nanchang University /ID# 269190 — Nanchang, Jiangxi, China
  • The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271904 — Xi'an, Shaanxi, China
  • Shanghai Chest Hospital /ID# 269155 — Shanghai, Shanghai Municipality, China
  • Shanghai Pulmonary Hospital /ID# 276397 — Shanghai, Shanghai Municipality, China
  • First Affiliated Hospital of Shanxi Medical University /ID# 276482 — Taiyuan, Shanxi, China
  • Sichuan Cancer Hospital /ID# 269712 — Chengdu, Sichuan, China
  • West China Hospital of Sichuan University /ID# 270244 — Chengdu, Sichuan, China
  • Yunnan Province Cancer Hospital /ID# 272331 — Kunming, Yunnan, China
  • Institut Bergonie /ID# 258377 — Bordeaux, Gironde, France
  • CHU Nantes - Hopital Laennec /ID# 268475 — Saint-Herblain, Loire-Atlantique, France
  • Institut de Cancerologie de l'Ouest Rene Gauducheau /ID# 268484 — Saint-Herblain, Loire-Atlantique, France
  • Centre De Cancerologie Du Grand Montpellier /ID# 273724 — Montpellier, Occitanie, France
  • Centre Antoine-Lacassagne /ID# 268486 — Nice, Provence-Alpes-Côte d'Azur Region, France
  • Institut Gustave Roussy /ID# 258373 — Villejuif, Val-de-Marne, France
  • Institut Curie /ID# 271395 — Paris, Île-de-France Region, France
  • Universitaetsklinikum Freiburg /ID# 268473 — Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Slk-Kliniken Heilbronn /ID# 269621 — Heilbronn, Baden-Wurttemberg, Germany
  • Hamatologie-Onkologie im Zentrum MVZ GmbH /ID# 273043 — Augsburg, Bavaria, Germany
  • Universitaetsklinikum Wuerzburg /ID# 275445 — Würzburg, Bavaria, Germany
  • Universitaetsklinikum Frankfurt /ID# 268721 — Frankfurt am Main, Hesse, Germany
  • Universitaetsklinikum Koeln /ID# 268489 — Cologne, North Rhine-Westphalia, Germany
  • Lungenklinik Hemer /ID# 269779 — Hemer, North Rhine-Westphalia, Germany
  • ohO Research GmbH /ID# 273060 — Oldenburg in Holstein, Schleswig-Holstein, Germany
  • Universitatsklinikum Jena /ID# 269700 — Jena, Thuringia, Germany
  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 268684 — Meldola, Forlì-Cesena, Italy
  • Istituto Europeo Di Oncologia /Id# 268670 — Milan, Milano, Italy
  • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 268626 — Rome, Roma, Italy
  • Azienda Ospedaliera Complesso Ospedaliero San Giovanni-Addolorata /ID# 273438 — Rome, Roma, Italy
  • Azienda Ospedaliero Universitaria delle Marche /ID# 268667 — Ancona, The Marches, Italy
  • Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 268641 — Orbassano, Torino, 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
  • Hirosaki University Hospital /ID# 274410 — Hirosaki, Aomori, Japan
  • Yokohama Municipal Citizen's Hospital /ID# 271979 — Yokohama, Kanagawa, Japan
  • Kyoto University Hospital /ID# 272312 — Kyoto, Kyoto, Japan
  • Niigata University Medical and Dental Hospital /ID# 274448 — Niigata, Niigata, Japan
  • Osaka Medical And Pharmaceutical University Hospital /ID# 273309 — Takatsuki, Osaka, Japan
  • National Cancer Center Hospital /ID# 273192 — Chuo-Ku, Tokyo, Japan
  • The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 271989 — Koto-ku, Tokyo, Japan
  • Nagasaki University Hospital /ID# 273310 — Nagasaki, Japan
  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 273170 — Lublin, Lublin Voivodeship, Poland
  • Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 276848 — Bialystok, Podlaskie Voivodeship, Poland
  • Uniwersyteckie Centrum Kliniczne /ID# 272418 — Gdansk, Pomeranian Voivodeship, Poland
  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 274549 — Kielce, Świętokrzyskie Voivodeship, Poland
  • Pan American Center for Oncology Trials - Rio Piedras /ID# 268827 — Rio Piedras, Puerto Rico
  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca /ID# 268725 — Cluj-Napoca, Cluj, Romania
  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca /ID# 273125 — Cluj-Napoca, Cluj, Romania
  • S.C. Radiotherapy Center Cluj SRL /ID# 268729 — Cluj-Napoca, Cluj, Romania
  • MNT Healthcare Europe SRL /ID# 269075 — Bucharest, Romania
  • Spitalul Clinic Coltea /ID# 268726 — Bucharest, Romania
  • Clinica MedLife Polisano Sibiu /ID# 269078 — Sibiu, Romania
  • Hospital Universitario Marques de Valdecilla /ID# 271314 — Santander, Cantabria, Spain
  • Hospital Universitario Virgen Macarena /ID# 271447 — Seville, Sevilla, Spain
  • Complejo Hospitalario Universitario A Coruna /ID# 271456 — A Coruña, Spain
  • Hospital General Universitario de Alicante /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
  • Hospital Universitario Virgen de la Victoria /ID# 271312 — Málaga, Spain
  • Changhua Christian Hospital /ID# 280139 — Changhua, Taiwan
  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 268789 — Chiayi City, Taiwan
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 268139 — Kaohsiung City, Taiwan
  • Kaohsiung Chang Gung Memorial Hospital /ID# 268138 — Kaohsiung 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 City, Taiwan
  • Gulhane Egitim ve Arastirma Hastanesi /ID# 280715 — Ankara, Antalya, Turkey (Türkiye)
  • Sakarya Egitim ve Arastirma Hastanesi /ID# 272878 — Adapazarı, Sakarya, Turkey (Türkiye)
  • Adana Medical Park Seyhan Hastanesi /ID# 272875 — Adana, Turkey (Türkiye)
  • Hacettepe Universitesi Tip Fakultesi /ID# 280631 — Ankara, Turkey (Türkiye)
  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 272873 — Ankara, Turkey (Türkiye)
  • Liv Hospital Ankara /ID# 272876 — Ankara, Turkey (Türkiye)
  • Pamukkale Universitesi /ID# 272893 — Denizli, Turkey (Türkiye)
  • Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 280635 — Istanbul, Turkey (Türkiye)
  • Necmettin Erbakan Universitesi Meram Tip Fakultesi - Eski Hastane /ID# 272882 — Konya, Turkey (Türkiye)
  • Ondokuz Mayis Universitesi /ID# 272899 — Samsun, Turkey (Türkiye)
  • Samsun Medical Park Hastanesi /ID# 272880 — Samsun, Turkey (Türkiye)
  • University Hospitals of Leicester NHS Trust /ID# 276035 — Leicester, Leicestershire, United Kingdom
  • Velindre Cancer Centre /ID# 271840 — Cardiff, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record