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NCT07155187From ClinicalTrials.govRecruiting

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

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

  • Non-Small Cell Lung Cancer

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
AbbVie
Enrolment target
490
Started
10 December 2025
Main results due
September 2030
Study sites
116
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(116)

  • Highlands Oncology Group - Springdale /ID# 277132

    Springdale, Arkansas, United States

    Recruiting

  • City of Hope National Medical Center /ID# 277005

    Duarte, California, United States

    Recruiting

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

    Irvine, California, United States

    Recruiting

  • UC San Diego Health - Moores Cancer Center /ID# 278836

    La Jolla, California, United States

    Recruiting

  • Cancer Specialists of North Florida /ID# 277332

    Jacksonville, Florida, United States

    Recruiting

  • Cancer Care Centers of Brevard- Rockledge /ID# 277853

    Rockledge, Florida, United States

    Recruiting

  • Moffitt Cancer Center /ID# 276785

    Tampa, Florida, United States

    Recruiting

  • Parkview Research Center /ID# 277651

    Fort Wayne, Indiana, United States

    Recruiting

  • HealthPartners Cancer Research Center /ID# 277339

    Saint Louis Park, Minnesota, United States

    Recruiting

  • Nho - Revive Research Institute /ID# 277569

    Lincoln, Nebraska, United States

    Recruiting

  • Dartmouth-Hitchcock Medical Center /ID# 277673

    Lebanon, New Hampshire, United States

    Recruiting

  • Astera Cancer Care /ID# 277570

    East Brunswick, New Jersey, United States

    Recruiting

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

    Knoxville, Tennessee, United States

    Recruiting

  • SCRI Oncology Partners /ID# 276959

    Nashville, Tennessee, United States

    Recruiting

  • Fred Hutchinson Cancer Center. /ID# 277939

    Seattle, Washington, United States

    Recruiting

  • Northwest Cancer Specialists - Vancouver /ID# 277855

    Vancouver, Washington, United States

    Recruiting

  • Canberra Hospital /ID# 277166

    Garran, Australian Capital Territory, Australia

    Recruiting

  • St George Hospital - Kogarah /ID# 277168

    Kogarah, New South Wales, Australia

    Recruiting

  • Mater Misericordiae /ID# 276985

    South Brisbane, Queensland, Australia

    Recruiting

  • Icon Cancer Centre Hobart /ID# 277549

    Hobart, Tasmania, Australia

    Recruiting

  • St Vincent's Hospital Melbourne /ID# 277002

    Fitzroy, Victoria, Australia

    Recruiting

  • Sunshine Hospital /ID# 276894

    St Albans, Victoria, Australia

    Recruiting

  • One Clinical Research - Nedlands /ID# 277598

    Nedlands, Western Australia, Australia

    Recruiting

  • Klinik Floridsdorf /ID# 276679

    Vienna, State of Vienna, Austria

    Recruiting

  • Institut Jules Bordet /ID# 277283

    Anderlecht, Brussels Capital, Belgium

    Recruiting

  • Grand Hopital de Charleroi - Les Viviers /ID# 277282

    Charleroi, Hainaut, Belgium

    Recruiting

  • Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202

    Hasselt, Limburg, Belgium

    Recruiting

  • Universitair Ziekenhuis Leuven /ID# 276874

    Leuven, Vlaams-Brabant, Belgium

    Recruiting

  • Groupe Sante CHC - Clinique du MontLegia /ID# 278951

    Liège, Belgium

    Recruiting

  • William Osler Health System - Brampton Civic Hospital /ID# 277798

    Brampton, Ontario, Canada

    Recruiting

  • Guangdong Provincial People's Hospital /ID# 277631

    Guangzhou, Guangdong, China

    Recruiting

  • The First Affiliated Hospital of Nanchang University - Xianghu Campus /ID# 277491

    Nanchang, Jiangxi, China

    Recruiting

  • Shanghai Pulmonary Hospital /ID# 277488

    Shanghai, Shanghai Municipality, China

    Recruiting

  • Xinjiang Medical University Cancer Hospital - Urumqi /ID# 277638

    Ürümqi, Xinjiang, China

    Recruiting

  • Assistance Publique Hopitaux de Marseille - Hopital Nord /ID# 277288

    Marseille, Bouches-du-Rhone, France

    Recruiting

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

    Brest, Finistere, France

    Recruiting

  • CHU de Lille - Institut Coeur Poumon /ID# 276868

    Lille, Hauts-de-France, France

    Recruiting

  • Hopital Arnaud de Villeneuve /ID# 276872

    Montpellier, Herault, France

    Recruiting

  • Institut Curie /ID# 277623

    Paris, Île-de-France Region, France

    Recruiting

  • Universitaetsklinikum Heidelberg /ID# 277275

    Heidelberg, Baden-Wurttemberg, Germany

    Recruiting

  • Universitaetsklinikum Wuerzburg /ID# 277213

    Würzburg, Bavaria, Germany

    Recruiting

  • Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873

    Marburg, Hesse, Germany

    Recruiting

  • Universitaetsklinikum Koeln /ID# 276862

    Cologne, North Rhine-Westphalia, Germany

    Recruiting

  • Universitatsklinikum Jena /ID# 277281

    Jena, Thuringia, Germany

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 276869

    Hamburg, Germany

    Recruiting

  • Meir Medical Center /ID# 277289

    Kefar Sava, Central District, Israel

    Recruiting

  • Rabin Medical Center /ID# 276748

    Petah Tikva, Central District, Israel

    Recruiting

  • Yitzhak Shamir Medical Center /ID# 276750

    Ẕerifin, Central District, Israel

    Recruiting

  • The Chaim Sheba Medical Center /ID# 276745

    Ramat Gan, Tel Aviv, Israel

    Recruiting

  • Rambam Health Care Campus- Haifa /ID# 276746

    Haifa, Israel

    Recruiting

  • Istituto Europeo Di Oncologia /ID# 276788

    Milan, Milano, Italy

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 276928

    Monza, Monza E Brianza, Italy

    Recruiting

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

    Fano, Pesaro E Urbino, Italy

    Recruiting

  • Centro Di Riferimento Oncologico /ID# 276923

    Aviano, Pordenone, Italy

    Recruiting

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

    Rome, Roma, Italy

    Recruiting

  • Ospedale Isola Tiberina - Gemelli Isola /ID# 277117

    Rome, Roma, Italy

    Recruiting

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

    Candiolo, Torino, Italy

    Recruiting

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

    Catania, Italy

    Recruiting

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

    Verona, Italy

    Recruiting

  • Hokkaido University Hospital /ID# 277240

    Sapporo, Hokkaido, Japan

    Recruiting

Showing 60 of 116 sites — filter to narrow it down. 116 of the 116 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07155187. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, | Trialion