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NCT07155187PHASE2, PHASE3Recruiting

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

AbbVie

Start Date

12/10/2025

Completion Date

9/1/2030

Summary

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Telisotuzumab Adizutecan

DRUG

Standard of Care

DRUG

Osimertinib

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Conditions

Non-Small Cell Lung Cancer

Locations

Highlands Oncology Group - Springdale /ID# 277132

Springdale, Arkansas 72762

United States

City of Hope National Medical Center /ID# 277005

Duarte, California 91010

United States

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928

Irvine, California 92618

United States

Cancer Specialists of North Florida /ID# 277332

Jacksonville, Florida 32256

United States

Cancer Care Centers of Brevard- Rockledge /ID# 277853

Rockledge, Florida 32955

United States

Moffitt Cancer Center /ID# 276785

Tampa, Florida 33612

United States

Parkview Research Center /ID# 277651

Fort Wayne, Indiana 46845

United States

HealthPartners Cancer Research Center /ID# 277339

Saint Louis Park, Minnesota 55426

United States

Nho - Revive Research Institute /ID# 277569

Lincoln, Nebraska 68506

United States

Dartmouth-Hitchcock Medical Center /ID# 277673

Lebanon, New Hampshire 03756

United States

Astera Cancer Care /ID# 277570

East Brunswick, New Jersey 08816-4096

United States

Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891

Knoxville, Tennessee 37909

United States

SCRI Oncology Partners /ID# 276959

Nashville, Tennessee 37203

United States

Fred Hutchinson Cancer Center. /ID# 277939

Seattle, Washington 98109-4405

United States

Northwest Cancer Specialists - Vancouver /ID# 277855

Vancouver, Washington 98684

United States

Canberra Hospital /ID# 277166

Garran, Australian Capital Territory 2605

Australia

St George Hospital - Kogarah /ID# 277168

Kogarah, New South Wales 2217

Australia

Mater Hospital Brisbane /ID# 276985

South Brisbane, Queensland 4101

Australia

Icon Cancer Centre Hobart /ID# 277549

Hobart, Tasmania 7000

Australia

St Vincent's Hospital Melbourne /ID# 277002

Fitzroy, Victoria 03065

Australia

Sunshine Hospital /ID# 276894

St Albans, Victoria 3021

Australia

One Clinical Research - Nedlands /ID# 277598

Nedlands, Western Australia 6009

Australia

Klinik Floridsdorf /ID# 276679

Vienna, State of Vienna 1210

Austria

Institut Jules Bordet /ID# 277283

Anderlecht, Brussels Capital 1070

Belgium

Grand Hopital de Charleroi - Les Viviers /ID# 277282

Charleroi, Hainaut 6280

Belgium

Groupe Sante CHC - Clinique du MontLegia /ID# 278951

Liège, Liege 4000

Belgium

Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202

Hasselt, Limburg 3500

Belgium

Universitair Ziekenhuis Leuven /ID# 276874

Leuven, Vlaams-Brabant 3000

Belgium

Guangdong Provincial People's Hospital /ID# 277631

Guangzhou, Guangdong 510080

China

The First affiliated hospital of Nanchang University (Xianghu campus) /ID# 277491

Nanchang, Jiangxi 330209

China

Shanghai Pulmonary Hospital /ID# 277488

Shanghai, Shanghai Municipality 200433

China

Xinjiang Medical University Cancer Hospital - Urumqi /ID# 277638

Ürümqi, Xinjiang 830000

China

CHU Brest - Hopital de la Cavale Blanche /ID# 277883

Brest, Finistere 29200

France

CHU de Lille - Institut Coeur Poumon /ID# 276868

Lille, Hauts-de-France 59000

France

Hopital Arnaud de Villeneuve /ID# 276872

Montpellier, Herault 34090

France

Institut Curie /ID# 277623

Paris, Île-de-France Region 75248

France

Universitaetsklinikum Heidelberg /ID# 277275

Heidelberg, Baden-Wurttemberg 69120

Germany

Universitaetsklinikum Wuerzburg /ID# 277213

Würzburg, Bavaria 97080

Germany

Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873

Marburg, Hesse 35043

Germany

Universitaetsklinikum Koeln /ID# 276862

Cologne, North Rhine-Westphalia 50937

Germany

Universitätsklinikum Jena /ID# 277281

Jena, Thuringia 07747

Germany

Universitaetsklinikum Hamburg-Eppendorf /ID# 276869

Hamburg, 20246

Germany

Meir Medical Center /ID# 277289

Kefar Sava, Central District 4428164

Israel

Rabin Medical Center /ID# 276748

Petah Tikva, Central District 4941492

Israel

Yitzhak Shamir Medical Center /ID# 276750

Ẕerifin, Central District 7030000

Israel

The Chaim Sheba Medical Center /ID# 276745

Ramat Gan, Tel Aviv 5265601

Israel

Rambam Health Care Campus- Haifa /ID# 276746

Haifa, 3109601

Israel

Istituto Europeo Di Oncologia /ID# 276788

Milan, Milano 20141

Italy

AST Pesaro Urbino - Presidio Ospedaliero Santa Croce Di Fano /ID# 277338

Fano, Pesaro E Urbino 61032

Italy

Centro Di Riferimento Oncologico /ID# 276923

Aviano, Pordenone 33081

Italy

IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 277296

Rome, Roma 00144

Italy

Ospedale Isola Tiberina - Gemelli Isola /ID# 277117

Rome, Roma 00186

Italy

Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119

Candiolo, Torino 10060

Italy

AOU Policlinico G. Rodolico - San Marco /ID# 277265

Catania, 95123

Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 277280

Verona, 37126

Italy

Hokkaido University Hospital /ID# 277240

Sapporo, Hokkaido 060-8648

Japan

Kitasato University Hospital /ID# 277241

Sagamihara-shi, Kanagawa 252-0375

Japan

National Cancer Center Hospital /ID# 277093

Chuo-Ku, Tokyo 104-0045

Japan

Wakayama Medical University Hospital /ID# 277238

Wakayama, Wakayama 641-8510

Japan

Radboudumc /ID# 277639

Nijmegen, Gelderland 6525 GA

Netherlands

Leids Universitair Medisch Centrum /ID# 277270

Leiden, South Holland 2333 ZA

Netherlands

Erasmus Medisch Centrum /ID# 276989

Rotterdam, South Holland 3015 CE

Netherlands

Universitair Medisch Centrum Utrecht /ID# 277114

Utrecht, 3584 CX

Netherlands

Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 277066

Poznan, Greater Poland Voivodeship 60-569

Poland

Pratia MCM Krakow /ID# 277118

Krakow, Lesser Poland Voivodeship 30-727

Poland

Provita Centrum Medyczne /ID# 277494

Warsaw, Masovian Voivodeship 00-585

Poland

Uniwersyteckie Centrum Kliniczne /ID# 277210

Gdansk, Pomeranian Voivodeship 80-214

Poland

Gyncentrum Sp. z o.o. /ID# 277522

Sosnowiec, Silesian Voivodeship 41-208

Poland

Unidade Local de Saude do Alto Ave, EPE /ID# 277249

Guimarães, Braga District 4835-044

Portugal

Unidade Local de Saude de Loures-Odivelas /ID# 277223

Loures, Lisbon District 2674-514

Portugal

Unidade Local de Saude de Matosinhos EPE /ID# 277228

Senhora da Hora, Porto District 4464-513

Portugal

Unidade Local de Saude de Braga, EPE /ID# 277217

Braga, 4710-243

Portugal

Unidade Local de Saude de Santo Antonio /ID# 277216

Porto, 4099-003

Portugal

Hospital Cuf Porto /ID# 277225

Porto, 4100-180

Portugal

University Clinical Center Serbia /ID# 277051

Belgrade, Beograd 11000

Serbia

Clinical Hospital Center - Bežanijska Kosa /ID# 277052

Belgrade, Beograd 11080

Serbia

University Clinical Center Nis /ID# 277200

Niš, Nisavski Okrug 18300

Serbia

Institute For Pulmonary Diseases Of Vojvodina /ID# 277047

Kamenitz, Sremski Okrug 21208

Serbia

University Clinical Center Kragujevac /ID# 277162

Kragujevac, Sumadijski Okrug 34000

Serbia

National Cancer Center /ID# 277353

Goyang-si, Gyeonggido 10408

South Korea

Chungbuk National University Hospital /ID# 277372

Cheongju-si, North Chungcheong 28644

South Korea

Seoul National University Hospital /ID# 277373

Seoul, Seoul Teugbyeolsi 03080

South Korea

Yonsei University Health System Severance Hospital /ID# 277394

Seoul, Seoul Teugbyeolsi 03722

South Korea

Asan Medical Center /ID# 277371

Seoul, Seoul Teugbyeolsi 05505

South Korea

Samsung Medical Center /ID# 277600

Seoul, Seoul Teugbyeolsi 06351

South Korea

Complejo Hospitalario Universitario de Santiago /ID# 277173

Santiago de Compostela, A Coruna 15706

Spain

Hospital Universitari Parc Tauli /ID# 277177

Sabadell, Barcelona 08208

Spain

Hospital Universitari Vall d Hebron /ID# 277156

Barcelona, 08035

Spain

Hospital Universitario Ramon y Cajal /ID# 277153

Madrid, 28034

Spain

Hospital Universitario 12 de Octubre /ID# 277155

Madrid, 28041

Spain

Hospital Universitario Virgen de la Victoria /ID# 277159

Málaga, 29010

Spain

Hospital Clinico Universitario de Valencia /ID# 277147

Valencia, 46010

Spain

Hospital Clinico Universitario Lozano Blesa /ID# 277154

Zaragoza, 50009

Spain

Changhua Christian Hospital /ID# 277145

Changhua, 500

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138

Kaohsiung City, 807

Taiwan

Kaohsiung Chang Gung Memorial Hospital /ID# 277472

Kaohsiung City, 833

Taiwan

Taichung Veterans General Hospital /ID# 277142

Taichung, 407

Taiwan

Mackay Memorial Hospital /ID# 277146

Taipei, 104

Taiwan

National Taiwan University Cancer Center (Ntucc) /ID# 277134

Taipei, 106

Taiwan

Taipei Veterans General Hospital /ID# 277141

Taipei, 112

Taiwan

Linkou Chang Gung Memorial Hospital /ID# 277135

Taoyuan City, 333

Taiwan

Sakarya Universitesi Tip Fakultesi - Korucuk Kampusu /ID# 276962

Adapazarı, Sakarya 54290

Turkey (Türkiye)

Adana Sehir Hastanesi /ID# 276957

Adana, 01370

Turkey (Türkiye)

Gazi University Medical Faculty /ID# 276943

Ankara, 06560

Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 276961

Ankara, 06620

Turkey (Türkiye)

Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276956

Istanbul, 34722

Turkey (Türkiye)

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 277063

Istanbul, 34899

Turkey (Türkiye)

Samsun Medical Park Hastanesi /ID# 277201

Samsun, 55200

Turkey (Türkiye)

St Bartholomews Hospital - Barts Health /ID# 277301

London, Greater London EC1A 7BE

United Kingdom

The Christie NHS Foundation Trust - Christie Hospital /ID# 277304

Manchester, M20 4BX

United Kingdom