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AzTrials

Non-Small Cell Lung CancerPhase 2/3NCT07155187

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 study testing Telisotuzumab Adizutecan and Osimertinib in people with Non-Small Cell Lung Cancer and c-MET, run by AbbVie at 117 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer, c-MET
What is being tested?
Telisotuzumab Adizutecan and Osimertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
490 participants
Where
117 sitesin 20 countries
Study dates
10 Dec 2025to Sep 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

117 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

117 sites in 20 countries

United States16 sites, 16 recruiting

  • City of Hope National Medical Center /ID# 277005

    Duarte, California, 91010

    Recruiting

  • Astera Cancer Care /ID# 277570

    East Brunswick, New Jersey, 08816-4096

    Recruiting

  • Parkview Research Center /ID# 277651

    Fort Wayne, Indiana, 46845

    Recruiting

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

    Irvine, California, 92618

    Recruiting

  • Cancer Specialists of North Florida /ID# 277332

    Jacksonville, Florida, 32256

    Recruiting

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

    Knoxville, Tennessee, 37909

    Recruiting

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

    La Jolla, California, 92037

    Recruiting

  • Dartmouth-Hitchcock Medical Center /ID# 277673

    Lebanon, New Hampshire, 03756

    Recruiting

  • Nho - Revive Research Institute /ID# 277569

    Lincoln, Nebraska, 68506

    Recruiting

  • SCRI Oncology Partners /ID# 276959

    Nashville, Tennessee, 37203

    Recruiting

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

    Rockledge, Florida, 32955

    Recruiting

  • HealthPartners Cancer Research Center /ID# 277339

    Saint Louis Park, Minnesota, 55426

    Recruiting

  • Fred Hutchinson Cancer Center. /ID# 277939

    Seattle, Washington, 98109-4405

    Recruiting

  • Highlands Oncology Group - Springdale /ID# 277132

    Springdale, Arkansas, 72762

    Site Coordinator, 479-872-8130

    Recruiting

  • Moffitt Cancer Center /ID# 276785

    Tampa, Florida, 33612

    Recruiting

  • Northwest Cancer Specialists - Vancouver /ID# 277855

    Vancouver, Washington, 98684

    Recruiting

Other trials in United States

Italy9 sites, 9 recruiting

  • Centro Di Riferimento Oncologico /ID# 276923

    Aviano, Pordenone, 33081

    Recruiting

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

    Candiolo, Torino, 10060

    Recruiting

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

    Catania, 95123

    Recruiting

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

    Fano, Pesaro E Urbino, 61032

    Recruiting

  • Istituto Europeo Di Oncologia /ID# 276788

    Milan, Milano, 20141

    Recruiting

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

    Monza, Monza E Brianza, 20900

    Recruiting

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

    Rome, Roma, 00144

    Recruiting

  • Ospedale Isola Tiberina - Gemelli Isola /ID# 277117

    Rome, Roma, 00186

    Recruiting

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

    Verona, 37126

    Recruiting

Other trials in Italy

Turkey (Türkiye)9 sites, 9 recruiting

  • Adana Sehir Hastanesi /ID# 276957

    Adana, 01370

    Recruiting

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

    Adapazarı, Sakarya, 54290

    Recruiting

  • Gazi University Medical Faculty /ID# 276943

    Ankara, 06560

    Recruiting

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 276961

    Ankara, 06620

    Recruiting

  • Liv Hospital Ankara /ID# 276950

    Ankara, 06680

    Recruiting

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

    Istanbul, 34722

    Recruiting

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

    Istanbul, 34899

    Recruiting

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

    Konya, 42080

    Recruiting

  • Samsun Medical Park Hastanesi /ID# 277201

    Samsun, 55200

    Recruiting

Other trials in Turkey (Türkiye)

Spain8 sites, 8 recruiting

  • Hospital Universitari Vall d Hebron /ID# 277156

    Barcelona, 08035

    Recruiting

  • Hospital Universitario Ramon y Cajal /ID# 277153

    Madrid, 28034

    Recruiting

  • Hospital Universitario 12 de Octubre /ID# 277155

    Madrid, 28041

    Recruiting

  • Hospital Universitario Virgen de la Victoria /ID# 277159

    Málaga, 29010

    Recruiting

  • Hospital Universitari Parc Tauli /ID# 277177

    Sabadell, Barcelona, 08208

    Recruiting

  • Complejo Hospitalario Universitario de Santiago /ID# 277173

    Santiago de Compostela, A Coruna, 15706

    Recruiting

  • Hospital Clinico Universitario de Valencia /ID# 277147

    Valencia, 46010

    Recruiting

  • Hospital Clinico Universitario Lozano Blesa /ID# 277154

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Taiwan8 sites, 8 recruiting

  • Changhua Christian Hospital /ID# 277145

    Changhua, 500

    Recruiting

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

    Kaohsiung City, 807

    Recruiting

  • Kaohsiung Chang Gung Memorial Hospital /ID# 277472

    Kaohsiung City, 833

    Recruiting

  • Taichung Veterans General Hospital /ID# 277142

    Taichung, 407

    Recruiting

  • Mackay Memorial Hospital /ID# 277146

    Taipei, 104

    Recruiting

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

    Taipei, 106

    Recruiting

  • Taipei Veterans General Hospital /ID# 277141

    Taipei, 112

    Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 277135

    Taoyuan City, 333

    Recruiting

Other trials in Taiwan

Australia7 sites, 7 recruiting

  • St Vincent's Hospital Melbourne /ID# 277002

    Fitzroy, Victoria, 03065

    Recruiting

  • Canberra Hospital /ID# 277166

    Garran, Australian Capital Territory, 2605

    Recruiting

  • Icon Cancer Centre Hobart /ID# 277549

    Hobart, Tasmania, 7000

    Recruiting

  • St George Hospital - Kogarah /ID# 277168

    Kogarah, New South Wales, 2217

    Recruiting

  • One Clinical Research - Nedlands /ID# 277598

    Nedlands, Western Australia, 6009

    Recruiting

  • Mater Misericordiae /ID# 276985

    South Brisbane, Queensland, 4101

    Recruiting

  • Sunshine Hospital /ID# 276894

    St Albans, Victoria, 3021

    Recruiting

Other trials in Australia

Germany6 sites, 6 recruiting

  • Universitaetsklinikum Koeln /ID# 276862

    Cologne, North Rhine-Westphalia, 50937

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 276869

    Hamburg, 20246

    Recruiting

  • Thoraxklinik-Heidelberg gGmbH /ID# 277275

    Heidelberg, Baden-Wurttemberg, 69126

    Recruiting

  • Universitatsklinikum Jena /ID# 277281

    Jena, Thuringia, 07747

    Recruiting

  • Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873

    Marburg, Hesse, 35043

    Recruiting

  • Universitaetsklinikum Wuerzburg /ID# 277213

    Würzburg, Bavaria, 97080

    Recruiting

Other trials in Germany

Portugal6 sites, 6 recruiting

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

    Braga, 4710-243

    Recruiting

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

    Guimarães, Braga District, 4835-044

    Recruiting

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

    Loures, Lisbon District, 2674-514

    Recruiting

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

    Porto, 4099-003

    Recruiting

  • Hospital Cuf Porto /ID# 277225

    Porto, 4100-180

    Recruiting

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

    Senhora da Hora, Porto District, 4464-513

    Recruiting

Other trials in Portugal

Serbia6 sites, 6 recruiting

  • Military Medical Academy /ID# 277053

    Belgrade, Beograd, 11000

    Recruiting

  • University Clinical Center Serbia /ID# 277051

    Belgrade, Beograd, 11000

    Recruiting

  • Clinical Hospital Center - Bezanijska Kosa /ID# 277052

    Belgrade, Beograd, 11080

    Recruiting

  • Institute For Pulmonary Diseases Of Vojvodina /ID# 277047

    Kamenitz, Sremski Okrug, 21208

    Recruiting

  • University Clinical Center Kragujevac /ID# 277162

    Kragujevac, Sumadijski Okrug, 34000

    Recruiting

  • University Clinical Center Nis /ID# 277200

    Niš, Nisavski Okrug, 18300

    Recruiting

Other trials in Serbia

South Korea6 sites, 6 recruiting

  • Chungbuk National University Hospital /ID# 277372

    Cheongju-si, North Chungcheong, 28644

    Recruiting

  • National Cancer Center /ID# 277353

    Goyang-si, Gyeonggido, 10408

    Recruiting

  • Seoul National University Hospital /ID# 277373

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

  • Yonsei University Health System Severance Hospital /ID# 277394

    Seoul, Seoul Teugbyeolsi, 03722

    Recruiting

  • Asan Medical Center /ID# 277371

    Seoul, Seoul Teugbyeolsi, 05505

    Recruiting

  • Samsung Medical Center /ID# 277600

    Seoul, Seoul Teugbyeolsi, 06351

    Recruiting

Other trials in South Korea

Belgium5 sites, 5 recruiting

  • Institut Jules Bordet /ID# 277283

    Anderlecht, Brussels Capital, 1070

    Recruiting

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

    Charleroi, Hainaut, 6280

    Recruiting

  • Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202

    Hasselt, Limburg, 3500

    Recruiting

  • Universitair Ziekenhuis Leuven /ID# 276874

    Leuven, Vlaams-Brabant, 3000

    Recruiting

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

    Liège, 4000

    Recruiting

Other trials in Belgium

France5 sites, 5 recruiting

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

    Brest, Finistere, 29200

    Recruiting

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

    Lille, Hauts-de-France, 59000

    Recruiting

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

    Marseille, Bouches-du-Rhone, 13915

    Recruiting

  • Hopital Arnaud de Villeneuve /ID# 276872

    Montpellier, Herault, 34090

    Recruiting

  • Institut Curie /ID# 277623

    Paris, Île-de-France Region, 75248

    Recruiting

Other trials in France

Israel5 sites, 5 recruiting

  • Rambam Health Care Campus- Haifa /ID# 276746

    Haifa, 3109601

    Recruiting

  • Meir Medical Center /ID# 277289

    Kefar Sava, Central District, 4428164

    Recruiting

  • Rabin Medical Center /ID# 276748

    Petah Tikva, Central District, 4941492

    Recruiting

  • The Chaim Sheba Medical Center /ID# 276745

    Ramat Gan, Tel Aviv, 5265601

    Recruiting

  • Yitzhak Shamir Medical Center /ID# 276750

    Tsrifin, Central District, 7030000

    Recruiting

Other trials in Israel

Poland5 sites, 5 recruiting

  • Uniwersyteckie Centrum Kliniczne /ID# 277210

    Gdansk, Pomeranian Voivodeship, 80-214

    Recruiting

  • Pratia MCM Krakow /ID# 277118

    Krakow, Lesser Poland Voivodeship, 30-727

    Recruiting

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

    Poznan, Greater Poland Voivodeship, 60-569

    Recruiting

  • Gyncentrum Sp. z o.o. /ID# 277522

    Sosnowiec, Silesian Voivodeship, 41-208

    Recruiting

  • Provita Centrum Medyczne /ID# 277494

    Warsaw, Masovian Voivodeship, 00-585

    Recruiting

Other trials in Poland

China4 sites, 4 recruiting

  • Guangdong Provincial People's Hospital /ID# 277631

    Guangzhou, Guangdong, 510080

    Recruiting

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

    Nanchang, Jiangxi, 330209

    Recruiting

  • Shanghai Pulmonary Hospital /ID# 277488

    Shanghai, Shanghai Municipality, 200433

    Recruiting

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

    Ürümqi, Xinjiang, 830000

    Recruiting

Other trials in China

Japan4 sites, 4 recruiting

  • National Cancer Center Hospital /ID# 277093

    Chuo-Ku, Tokyo, 104-0045

    Recruiting

  • Kitasato University Hospital /ID# 277241

    Sagamihara-shi, Kanagawa, 252-0375

    Recruiting

  • Hokkaido University Hospital /ID# 277240

    Sapporo, Hokkaido, 060-8648

    Recruiting

  • Wakayama Medical University Hospital /ID# 277238

    Wakayama, Wakayama, 641-8510

    Recruiting

Other trials in Japan

Netherlands4 sites, 4 recruiting

  • Leids Universitair Medisch Centrum /ID# 277270

    Leiden, South Holland, 2333 ZA

    Recruiting

  • Radboudumc /ID# 277639

    Nijmegen, Gelderland, 6525 GA

    Recruiting

  • Erasmus Medisch Centrum /ID# 276989

    Rotterdam, South Holland, 3015 CE

    Recruiting

  • Universitair Medisch Centrum Utrecht /ID# 277114

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

United Kingdom2 sites, 2 recruiting

  • St Bartholomews Hospital - Barts Health /ID# 277301

    London, Greater London, EC1A 7BE

    Recruiting

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

    Manchester, M20 4BX

    Recruiting

Other trials in United Kingdom

Austria1 site, 1 recruiting

  • Klinik Floridsdorf /ID# 276679

    Vienna, State of Vienna, 1210

    Recruiting

Other trials in Austria

Canada1 site, 1 recruiting

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

    Brampton, Ontario, L6R 3J7

    Recruiting

Other trials in Canada

About this study

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

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.

Read more

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.

Being tested
Telisotuzumab Adizutecan, Standard of Care, Osimertinib
Keywords
Non-Small Cell Lung Cancer, Telisotuzumab Adizutecan, ABBV-400, Osimertinib, Standard of Care, Cancer, AndroMETa-Lung-713
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telisotuzumab AdizutecanDrug

    Intravenous (IV) Infusion

  • Standard of CareDrug

    Standard of Care

  • OsimertinibDrug

    Oral

Study groups in NCT07155187
Study groupRoleWhat they receive
Phase 2: Telisotuzumab Adizutecan Dose AExperimentalParticipants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration.
Receives: Drug: Telisotuzumab Adizutecan
Phase 2: Telisotuzumab Adizutecan Dose BExperimentalParticipants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration.
Receives: Drug: Telisotuzumab Adizutecan
Phase 2: Telisotuzumab Adizutecan Dose A + OsimertinibExperimentalParticipants will receive telisotuzumab adizutecan dose A in combination with osimertinib, as part of the approximately 69 month study duration.
Receives: Drug: Telisotuzumab Adizutecan; Drug: Osimertinib
Phase 2: Telisotuzumab Adizutecan Dose B + OsimertinibExperimentalParticipants will receive telisotuzumab adizutecan dose B in combination with osimertinib, as part of the approximately 69 month study duration.
Receives: Drug: Telisotuzumab Adizutecan; Drug: Osimertinib
Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 DoseExperimentalParticipants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration.
Receives: Drug: Telisotuzumab Adizutecan
Phase 3: Stand of Care (SOC)ExperimentalParticipants will receive investigator's choice of SOC, as part of the approximately 69 month study duration.
Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR)

    OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per the BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Up to Approximately 69 Months

  2. Phase 3: Progression-Free Survival (PFS) as assessed by the BICR

    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the BICR or death from any cause, whichever occurs earlier.

    Measured: Up to Approximately 69 Months

Secondary outcomes (8)

  1. Phase 2 and 3: Overall Survival (OS)

    OS is defined as the time from randomization to the event of death from any cause.

    Measured: Up to Approximately 69 Months

  2. Phase 2: PFS as assessed by the BICR

    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the BICR or death from any cause, whichever occurs earlier.

    Measured: Up to Approximately 69 Months

  3. Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per RECIST v1.1

    DoR is defined as the time from the first response (CR or PR) to Progressive Disease (PD) or death (whichever occurs first) amongst confirmed responders.

    Measured: Up to Approximately 69 Months

  4. Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1

    DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1.

    Measured: Up to Approximately 69 Months

  5. Phase 3: OR Assessed by the BICR

    OR is defined as participants achieving a best overall response of confirmed CR or confirmed PR per the BICR based on RECIST version 1.1.

    Measured: Up to Approximately 69 Months

  6. Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)

    Health-related quality-of-life and symptoms will be assessed with the EORTC QLQ-C30, version 3.0. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status (GHS)/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).

    Measured: Up to Week 12

  7. Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13)

    The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much).

    Measured: Up to Week 12

  8. Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30

    Health-related quality-of-life and symptoms will be assessed with the EORTC QLQ-C30, version 3.0. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a GHS/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).

    Measured: Up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start10 Dec 2025
  3. Primary completionSep 2030 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
490 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07155187
Sponsor's protocol ID
M25-713
Other IDs
2025-521124-29, 2025
Status last verified
Oct 2026
First submitted
28 Aug 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Telisotuzumab Adizutecan and Osimertinib in people with Non-Small Cell Lung Cancer and c-MET, run by AbbVie at 117 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Italy, Turkey (Türkiye), Spain, Taiwan and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR) (time frame: Up to Approximately 69 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07155187.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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