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New hope for lung cancer patients whose treatment has failed

NCT ID NCT07155187

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This study tests a new drug, telisotuzumab adizutecan, in people with advanced EGFR-mutated non-small cell lung cancer whose cancer has progressed after a third-generation targeted therapy. About 430 adults will receive either the new drug or standard care. The goal is to see if the new drug can shrink tumors or delay cancer growth better than current options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
telisotuzumab adizutecan
What this could lead to
If it works, this could offer a new treatment option for people with a specific type of lung cancer that has stopped responding to current targeted therapies.
What could go wrong
This is an early-to-mid-stage trial, so the drug may not prove more effective than standard care. Side effects from the investigational drug are not yet fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 490 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    116 sites in 20 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Catania, 95123, Italy

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

    RECRUITING

    Fano, Pesaro E Urbino, 61032, Italy

  • Adana Sehir Hastanesi /ID# 276957

    RECRUITING

    Adana, 01370, Turkey (Türkiye)

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 276961

    RECRUITING

    Ankara, 06620, Turkey (Türkiye)

  • Asan Medical Center /ID# 277371

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

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

    RECRUITING

    Marseille, Bouches-du-Rhone, 13915, France

  • Astera Cancer Care /ID# 277570

    RECRUITING

    East Brunswick, New Jersey, 08816-4096, United States

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

    RECRUITING

    Verona, 37126, Italy

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

    RECRUITING

    Brest, Finistere, 29200, France

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

    RECRUITING

    Lille, Hauts-de-France, 59000, France

  • Canberra Hospital /ID# 277166

    RECRUITING

    Garran, Australian Capital Territory, 2605, Australia

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

    RECRUITING

    Rockledge, Florida, 32955, United States

  • Cancer Specialists of North Florida /ID# 277332

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Centro Di Riferimento Oncologico /ID# 276923

    RECRUITING

    Aviano, Pordenone, 33081, Italy

  • Changhua Christian Hospital /ID# 277145

    RECRUITING

    Changhua, 500, Taiwan

  • Chungbuk National University Hospital /ID# 277372

    RECRUITING

    Cheongju-si, North Chungcheong, 28644, South Korea

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

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope National Medical Center /ID# 277005

    RECRUITING

    Duarte, California, 91010, United States

  • Clinical Hospital Center - Bezanijska Kosa /ID# 277052

    RECRUITING

    Belgrade, Beograd, 11080, Serbia

  • Complejo Hospitalario Universitario de Santiago /ID# 277173

    RECRUITING

    Santiago de Compostela, A Coruna, 15706, Spain

  • Dartmouth-Hitchcock Medical Center /ID# 277673

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Erasmus Medisch Centrum /ID# 276989

    RECRUITING

    Rotterdam, South Holland, 3015 CE, Netherlands

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

    RECRUITING

    Monza, Monza E Brianza, 20900, Italy

  • Fred Hutchinson Cancer Center. /ID# 277939

    RECRUITING

    Seattle, Washington, 98109-4405, United States

  • Gazi University Medical Faculty /ID# 276943

    RECRUITING

    Ankara, 06560, Turkey (Türkiye)

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

    RECRUITING

    Istanbul, 34722, Turkey (Türkiye)

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

    RECRUITING

    Charleroi, Hainaut, 6280, Belgium

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

    RECRUITING

    Liège, Liege, 4000, Belgium

  • Guangdong Provincial People's Hospital /ID# 277631

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Gyncentrum Sp. z o.o. /ID# 277522

    RECRUITING

    Sosnowiec, Silesian Voivodeship, 41-208, Poland

  • HealthPartners Cancer Research Center /ID# 277339

    RECRUITING

    Saint Louis Park, Minnesota, 55426, United States

  • Highlands Oncology Group - Springdale /ID# 277132

    RECRUITING

    Springdale, Arkansas, 72762, United States

  • Hokkaido University Hospital /ID# 277240

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • Hopital Arnaud de Villeneuve /ID# 276872

    RECRUITING

    Montpellier, Herault, 34090, France

  • Hospital Clinico Universitario Lozano Blesa /ID# 277154

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Clinico Universitario de Valencia /ID# 277147

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Cuf Porto /ID# 277225

    RECRUITING

    Porto, 4100-180, Portugal

  • Hospital Universitari Parc Tauli /ID# 277177

    RECRUITING

    Sabadell, Barcelona, 08208, Spain

  • Hospital Universitari Vall d Hebron /ID# 277156

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre /ID# 277155

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal /ID# 277153

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de la Victoria /ID# 277159

    RECRUITING

    Málaga, 29010, Spain

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

    RECRUITING

    Rome, Roma, 00144, Italy

  • Icon Cancer Centre Hobart /ID# 277549

    RECRUITING

    Hobart, Tasmania, 7000, Australia

  • Institut Curie /ID# 277623

    RECRUITING

    Paris, Île-de-France Region, 75248, France

  • Institut Jules Bordet /ID# 277283

    RECRUITING

    Anderlecht, Brussels Capital, 1070, Belgium

  • Institute For Pulmonary Diseases Of Vojvodina /ID# 277047

    RECRUITING

    Kamenitz, Sremski Okrug, 21208, Serbia

  • Istituto Europeo Di Oncologia /ID# 276788

    RECRUITING

    Milan, Milano, 20141, Italy

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

    RECRUITING

    Candiolo, Torino, 10060, Italy

  • Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202

    RECRUITING

    Hasselt, Limburg, 3500, Belgium

  • Kaohsiung Chang Gung Memorial Hospital /ID# 277472

    RECRUITING

    Kaohsiung City, 833, Taiwan

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

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Kitasato University Hospital /ID# 277241

    RECRUITING

    Sagamihara-shi, Kanagawa, 252-0375, Japan

  • Klinik Floridsdorf /ID# 276679

    RECRUITING

    Vienna, State of Vienna, 1210, Austria

  • Leids Universitair Medisch Centrum /ID# 277270

    RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • Linkou Chang Gung Memorial Hospital /ID# 277135

    RECRUITING

    Taoyuan City, 333, Taiwan

  • Liv Hospital Ankara /ID# 276950

    RECRUITING

    Ankara, 06680, Turkey (Türkiye)

  • Mackay Memorial Hospital /ID# 277146

    RECRUITING

    Taipei, 104, Taiwan

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 277063

    RECRUITING

    Istanbul, 34899, Turkey (Türkiye)

  • Mater Misericordiae /ID# 276985

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Meir Medical Center /ID# 277289

    RECRUITING

    Kefar Sava, Central District, 4428164, Israel

  • Moffitt Cancer Center /ID# 276785

    RECRUITING

    Tampa, Florida, 33612, United States

  • National Cancer Center /ID# 277353

    RECRUITING

    Goyang-si, Gyeonggido, 10408, South Korea

  • National Cancer Center Hospital /ID# 277093

    RECRUITING

    Chuo-Ku, Tokyo, 104-0045, Japan

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

    RECRUITING

    Taipei, 106, Taiwan

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi - Eski Hastane /ID# 276946

    RECRUITING

    Konya, 42080, Turkey (Türkiye)

  • Nho - Revive Research Institute /ID# 277569

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • Northwest Cancer Specialists - Vancouver /ID# 277855

    RECRUITING

    Vancouver, Washington, 98684, United States

  • One Clinical Research - Nedlands /ID# 277598

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Ospedale Isola Tiberina - Gemelli Isola /ID# 277117

    RECRUITING

    Rome, Roma, 00186, Italy

  • Parkview Research Center /ID# 277651

    RECRUITING

    Fort Wayne, Indiana, 46845, United States

  • Pratia MCM Krakow /ID# 277118

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Provita Centrum Medyczne /ID# 277494

    RECRUITING

    Warsaw, Masovian Voivodeship, 00-585, Poland

  • Rabin Medical Center /ID# 276748

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Radboudumc /ID# 277639

    RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Rambam Health Care Campus- Haifa /ID# 276746

    RECRUITING

    Haifa, 3109601, Israel

  • SCRI Oncology Partners /ID# 276959

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sakarya Universitesi Tip Fakultesi - Korucuk Kampusu /ID# 276962

    RECRUITING

    Adapazarı, Sakarya, 54290, Turkey (Türkiye)

  • Samsun Medical Park Hastanesi /ID# 277201

    RECRUITING

    Samsun, 55200, Turkey (Türkiye)

  • Samsung Medical Center /ID# 277600

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital /ID# 277373

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Shanghai Pulmonary Hospital /ID# 277488

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • St Bartholomews Hospital - Barts Health /ID# 277301

    RECRUITING

    London, Greater London, EC1A 7BE, United Kingdom

  • St George Hospital - Kogarah /ID# 277168

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • St Vincent's Hospital Melbourne /ID# 277002

    RECRUITING

    Fitzroy, Victoria, 03065, Australia

  • Sunshine Hospital /ID# 276894

    RECRUITING

    St Albans, Victoria, 3021, Australia

  • Taichung Veterans General Hospital /ID# 277142

    RECRUITING

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital /ID# 277141

    RECRUITING

    Taipei, 112, Taiwan

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

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • The Chaim Sheba Medical Center /ID# 276745

    RECRUITING

    Ramat Gan, Tel Aviv, 5265601, Israel

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

    RECRUITING

    Manchester, M20 4BX, United Kingdom

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

    RECRUITING

    Nanchang, Jiangxi, 330209, China

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

    RECRUITING

    La Jolla, California, 92037, United States

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

    RECRUITING

    Braga, 4710-243, Portugal

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

    RECRUITING

    Loures, Lisbon District, 2674-514, Portugal

  • Unidade Local de Saude de Matosinhos EPE /ID# 277228

    RECRUITING

    Senhora da Hora, Porto District, 4464-513, Portugal

  • Unidade Local de Saude de Santo Antonio /ID# 277216

    RECRUITING

    Porto, 4099-003, Portugal

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

    RECRUITING

    Guimarães, Braga District, 4835-044, Portugal

  • Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873

    RECRUITING

    Marburg, Hesse, 35043, Germany

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 276869

    RECRUITING

    Hamburg, 20246, Germany

  • Universitaetsklinikum Heidelberg /ID# 277275

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitaetsklinikum Koeln /ID# 276862

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitaetsklinikum Wuerzburg /ID# 277213

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Universitair Medisch Centrum Utrecht /ID# 277114

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • Universitair Ziekenhuis Leuven /ID# 276874

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Universitatsklinikum Jena /ID# 277281

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • University Clinical Center Kragujevac /ID# 277162

    RECRUITING

    Kragujevac, Sumadijski Okrug, 34000, Serbia

  • University Clinical Center Nis /ID# 277200

    RECRUITING

    Niš, Nisavski Okrug, 18300, Serbia

  • University Clinical Center Serbia /ID# 277051

    RECRUITING

    Belgrade, Beograd, 11000, Serbia

  • Uniwersyteckie Centrum Kliniczne /ID# 277210

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Wakayama Medical University Hospital /ID# 277238

    RECRUITING

    Wakayama, Wakayama, 641-8510, Japan

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

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-569, Poland

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

    RECRUITING

    Brampton, Ontario, L6R 3J7, Canada

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

    RECRUITING

    Ürümqi, Xinjiang, 830000, China

  • Yitzhak Shamir Medical Center /ID# 276750

    RECRUITING

    Ẕerifin, Central District, 7030000, Israel

  • Yonsei University Health System Severance Hospital /ID# 277394

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

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