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A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

NCT07155187 · AbbVie
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Official title
A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713
About this study
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 490 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan as a monotherapy or in combination with oral osimertinib. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 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.
Eligibility criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation. * Provide recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable. * Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry. Participant who has received prior third-generation EGFR TKI therapy in the adjuvant setting must have progressed while on treatment. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated. Exclusion Criteria: * Tumor(s) have adenosquamous or squamous histology or sarcomatoid features. * Received more than 1 line of systemic therapy in the locally advanced or metastatic setting. * Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable. * Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids. * Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
Study design
Enrollment target: 490 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-10
Estimated completion: 2030-09
Last updated: 2026-09-15
Interventions
Drug: Telisotuzumab AdizutecanDrug: Standard of CareDrug: Osimertinib
Primary outcomes
  • Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR) (Up to Approximately 69 Months)
  • Phase 3: Progression-Free Survival (PFS) as assessed by the BICR (Up to Approximately 69 Months)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (116)
Highlands Oncology Group - Springdale /ID# 277132Recruiting
Springdale, Arkansas, United States
City of Hope National Medical Center /ID# 277005Recruiting
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928Recruiting
Irvine, California, United States
UC San Diego Health - Moores Cancer Center /ID# 278836Recruiting
La Jolla, California, United States
Cancer Specialists of North Florida /ID# 277332Recruiting
Jacksonville, Florida, United States
Cancer Care Centers of Brevard- Rockledge /ID# 277853Recruiting
Rockledge, Florida, United States
Moffitt Cancer Center /ID# 276785Recruiting
Tampa, Florida, United States
Parkview Research Center /ID# 277651Recruiting
Fort Wayne, Indiana, United States
HealthPartners Cancer Research Center /ID# 277339Recruiting
Saint Louis Park, Minnesota, United States
Nho - Revive Research Institute /ID# 277569Recruiting
Lincoln, Nebraska, United States
Dartmouth-Hitchcock Medical Center /ID# 277673Recruiting
Lebanon, New Hampshire, United States
Astera Cancer Care /ID# 277570Recruiting
East Brunswick, New Jersey, United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891Recruiting
Knoxville, Tennessee, United States
SCRI Oncology Partners /ID# 276959Recruiting
Nashville, Tennessee, United States
Fred Hutchinson Cancer Center. /ID# 277939Recruiting
Seattle, Washington, United States
Northwest Cancer Specialists - Vancouver /ID# 277855Recruiting
Vancouver, Washington, United States
Canberra Hospital /ID# 277166Recruiting
Garran, Australian Capital Territory, Australia
St George Hospital - Kogarah /ID# 277168Recruiting
Kogarah, New South Wales, Australia
Mater Misericordiae /ID# 276985Recruiting
South Brisbane, Queensland, Australia
Icon Cancer Centre Hobart /ID# 277549Recruiting
Hobart, Tasmania, Australia
St Vincent's Hospital Melbourne /ID# 277002Recruiting
Fitzroy, Victoria, Australia
Sunshine Hospital /ID# 276894Recruiting
St Albans, Victoria, Australia
One Clinical Research - Nedlands /ID# 277598Recruiting
Nedlands, Western Australia, Australia
Klinik Floridsdorf /ID# 276679Recruiting
Vienna, State of Vienna, Austria
Institut Jules Bordet /ID# 277283Recruiting
Anderlecht, Brussels Capital, Belgium
Grand Hopital de Charleroi - Les Viviers /ID# 277282Recruiting
Charleroi, Hainaut, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 278951Recruiting
Liège, Liege, Belgium
Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202Recruiting
Hasselt, Limburg, Belgium
Universitair Ziekenhuis Leuven /ID# 276874Recruiting
Leuven, Vlaams-Brabant, Belgium
William Osler Health System - Brampton Civic Hospital /ID# 277798Recruiting
Brampton, Ontario, Canada
Guangdong Provincial People's Hospital /ID# 277631Recruiting
Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanchang University - Xianghu Campus /ID# 277491Recruiting
Nanchang, Jiangxi, China
Shanghai Pulmonary Hospital /ID# 277488Recruiting
Shanghai, Shanghai Municipality, China
Xinjiang Medical University Cancer Hospital - Urumqi /ID# 277638Recruiting
Ürümqi, Xinjiang, China
Assistance Publique Hopitaux de Marseille - Hopital Nord /ID# 277288Recruiting
Marseille, Bouches-du-Rhone, France
CHU Brest - Hopital de la Cavale Blanche /ID# 277883Recruiting
Brest, Finistere, France
CHU de Lille - Institut Coeur Poumon /ID# 276868Recruiting
Lille, Hauts-de-France, France
Hopital Arnaud de Villeneuve /ID# 276872Recruiting
Montpellier, Herault, France
Institut Curie /ID# 277623Recruiting
Paris, Île-de-France Region, France
Universitaetsklinikum Heidelberg /ID# 277275Recruiting
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Wuerzburg /ID# 277213Recruiting
Würzburg, Bavaria, Germany
Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873Recruiting
Marburg, Hesse, Germany
Universitaetsklinikum Koeln /ID# 276862Recruiting
Cologne, North Rhine-Westphalia, Germany
Universitatsklinikum Jena /ID# 277281Recruiting
Jena, Thuringia, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 276869Recruiting
Hamburg, Germany
Meir Medical Center /ID# 277289Recruiting
Kefar Sava, Central District, Israel
Rabin Medical Center /ID# 276748Recruiting
Petah Tikva, Central District, Israel
Yitzhak Shamir Medical Center /ID# 276750Recruiting
Ẕerifin, Central District, Israel
The Chaim Sheba Medical Center /ID# 276745Recruiting
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 276746Recruiting
Haifa, Israel
Istituto Europeo Di Oncologia /ID# 276788Recruiting
Milan, Milano, Italy
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 276928Recruiting
Monza, Monza E Brianza, Italy
AST Pesaro Urbino - Presidio Ospedaliero Santa Croce Di Fano /ID# 277338Recruiting
Fano, Pesaro E Urbino, Italy
Centro Di Riferimento Oncologico /ID# 276923Recruiting
Aviano, Pordenone, Italy
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 277296Recruiting
Rome, Roma, Italy
Ospedale Isola Tiberina - Gemelli Isola /ID# 277117Recruiting
Rome, Roma, Italy
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119Recruiting
Candiolo, Torino, Italy
AOU Policlinico G. Rodolico - San Marco /ID# 277265Recruiting
Catania, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 277280Recruiting
Verona, Italy
Hokkaido University Hospital /ID# 277240Recruiting
Sapporo, Hokkaido, Japan
Kitasato University Hospital /ID# 277241Recruiting
Sagamihara-shi, Kanagawa, Japan
National Cancer Center Hospital /ID# 277093Recruiting
Chuo-Ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 277238Recruiting
Wakayama, Wakayama, Japan
Radboudumc /ID# 277639Recruiting
Nijmegen, Gelderland, Netherlands
Leids Universitair Medisch Centrum /ID# 277270Recruiting
Leiden, South Holland, Netherlands
Erasmus Medisch Centrum /ID# 276989Recruiting
Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum Utrecht /ID# 277114Recruiting
Utrecht, Netherlands
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 277066Recruiting
Poznan, Greater Poland Voivodeship, Poland
Pratia MCM Krakow /ID# 277118Recruiting
Krakow, Lesser Poland Voivodeship, Poland
Provita Centrum Medyczne /ID# 277494Recruiting
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne /ID# 277210Recruiting
Gdansk, Pomeranian Voivodeship, Poland
Gyncentrum Sp. z o.o. /ID# 277522Recruiting
Sosnowiec, Silesian Voivodeship, Poland
Unidade Local de Saude do Alto Ave, EPE /ID# 277249Recruiting
Guimarães, Braga District, Portugal
Unidade Local de Saude de Loures-Odivelas /ID# 277223Recruiting
Loures, Lisbon District, Portugal
Unidade Local de Saude de Matosinhos EPE /ID# 277228Recruiting
Senhora da Hora, Porto District, Portugal
Unidade Local de Saude de Braga, EPE /ID# 277217Recruiting
Braga, Portugal
Unidade Local de Saude de Santo Antonio /ID# 277216Recruiting
Porto, Portugal
Hospital Cuf Porto /ID# 277225Recruiting
Porto, Portugal
University Clinical Center Serbia /ID# 277051Recruiting
Belgrade, Beograd, Serbia
Clinical Hospital Center - Bezanijska Kosa /ID# 277052Recruiting
Belgrade, Beograd, Serbia
University Clinical Center Nis /ID# 277200Recruiting
Niš, Nisavski Okrug, Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 277047Recruiting
Kamenitz, Sremski Okrug, Serbia
University Clinical Center Kragujevac /ID# 277162Recruiting
Kragujevac, Sumadijski Okrug, Serbia
National Cancer Center /ID# 277353Recruiting
Goyang-si, Gyeonggido, South Korea
Chungbuk National University Hospital /ID# 277372Recruiting
Cheongju-si, North Chungcheong, South Korea
Seoul National University Hospital /ID# 277373Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 277394Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 277371Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 277600Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Complejo Hospitalario Universitario de Santiago /ID# 277173Recruiting
Santiago de Compostela, A Coruna, Spain
Hospital Universitari Parc Tauli /ID# 277177Recruiting
Sabadell, Barcelona, Spain
Hospital Universitari Vall d Hebron /ID# 277156Recruiting
Barcelona, Spain
Hospital Universitario Ramon y Cajal /ID# 277153Recruiting
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 277155Recruiting
Madrid, Spain
Hospital Universitario Virgen de la Victoria /ID# 277159Recruiting
Málaga, Spain
Hospital Clinico Universitario de Valencia /ID# 277147Recruiting
Valencia, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 277154Recruiting
Zaragoza, Spain
Changhua Christian Hospital /ID# 277145Recruiting
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138Recruiting
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 277472Recruiting
Kaohsiung City, Taiwan
Taichung Veterans General Hospital /ID# 277142Recruiting
Taichung, Taiwan
Mackay Memorial Hospital /ID# 277146Recruiting
Taipei, Taiwan
National Taiwan University Cancer Center (Ntucc) /ID# 277134Recruiting
Taipei, Taiwan
Taipei Veterans General Hospital /ID# 277141Recruiting
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 277135Recruiting
Taoyuan City, Taiwan
Sakarya Universitesi Tip Fakultesi - Korucuk Kampusu /ID# 276962Recruiting
Adapazarı, Sakarya, Turkey (Türkiye)
Adana Sehir Hastanesi /ID# 276957Recruiting
Adana, Turkey (Türkiye)
Gazi University Medical Faculty /ID# 276943Recruiting
Ankara, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 276961Recruiting
Ankara, Turkey (Türkiye)
Liv Hospital Ankara /ID# 276950Recruiting
Ankara, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276956Recruiting
Istanbul, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 277063Recruiting
Istanbul, Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi - Eski Hastane /ID# 276946Recruiting
Konya, Turkey (Türkiye)
Samsun Medical Park Hastanesi /ID# 277201Recruiting
Samsun, Turkey (Türkiye)
St Bartholomews Hospital - Barts Health /ID# 277301Recruiting
London, Greater London, United Kingdom
The Christie NHS Foundation Trust - Christie Hospital /ID# 277304Recruiting
Manchester, United Kingdom
A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer · TrialPath