RecruitingPhase 2Phase 3NCT07155187

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

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan 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

Sponsor

AbbVie

Enrollment

430 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

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 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. 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 430 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. 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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new drug called telisotuzumab adizutecan (an antibody-drug conjugate that targets a protein called c-Met) against standard treatment options in people with advanced non-small cell lung cancer that has a specific EGFR gene mutation and has progressed after targeted therapy. **You may be eligible if...** - You have confirmed advanced non-squamous non-small cell lung cancer with an EGFR Exon 19 deletion or Exon 21 L858R mutation - You have received one prior third-generation EGFR-targeted therapy (like osimertinib) and your cancer has since progressed - You have at least one measurable tumor that has not been previously irradiated - Your overall health allows treatment (ECOG score 0–1) - Brain metastases are allowed if they are stable or asymptomatic **You may NOT be eligible if...** - Your tumor has squamous, adenosquamous, or sarcomatoid features - You have received more than one line of treatment for advanced or metastatic disease - You have a history of interstitial lung disease requiring steroids - You have other serious medical conditions that would affect participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTelisotuzumab Adizutecan

Intravenous (IV) Infusion

DRUGStandard of Care

Standard of Care

Locations(53)

Highlands Oncology Group - Springdale /ID# 277132

Springdale, Arkansas, United States

Cancer Care Centers of Brevard- Rockledge /ID# 277853

Rockledge, Florida, United States

HealthPartners Cancer Research Center /ID# 277339

Saint Louis Park, Minnesota, United States

Nho - Revive Research Institute /ID# 277569

Lincoln, Nebraska, United States

Astera Cancer Care /ID# 277570

East Brunswick, New Jersey, United States

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

Knoxville, Tennessee, United States

SCRI Oncology Partners /ID# 276959

Nashville, Tennessee, United States

Northwest Cancer Specialists - Vancouver /ID# 277855

Vancouver, Washington, United States

Canberra Hospital /ID# 277166

Garran, Australian Capital Territory, Australia

St George Hospital /ID# 277168

Kogarah, New South Wales, Australia

Mater Hospital Brisbane /ID# 276985

South Brisbane, Queensland, Australia

Icon Cancer Centre Hobart /ID# 277549

Hobart, Tasmania, Australia

St Vincent's Hospital Melbourne /ID# 277002

Fitzroy, Victoria, Australia

Sunshine Hospital /ID# 276894

St Albans, Victoria, Australia

One Clinical Research - Nedlands /ID# 277598

Nedlands, Western Australia, Australia

Klinik Floridsdorf /ID# 276679

Vienna, State of Vienna, Austria

Jessa Ziekenhuis - Campus Virga Jesse /ID# 277202

Hasselt, Limburg, Belgium

Universitair Ziekenhuis Leuven /ID# 276874

Leuven, Vlaams-Brabant, Belgium

Guangdong Provincial People'S Hospital /ID# 277631

Guangzhou, Guangdong, China

Universitaetsklinikum Heidelberg /ID# 277275

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Wuerzburg /ID# 277213

Würzburg, Bavaria, Germany

Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873

Marburg, Hesse, Germany

Universitaetsklinikum Koeln /ID# 276862

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Jena /ID# 277281

Jena, Thuringia, Germany

Meir Medical Center /ID# 277289

Kfar Saba, Central District, Israel

Rabin Medical Center /ID# 276748

Petah Tikva, Central District, Israel

Yitzhak Shamir Medical Center /ID# 276750

Ẕerifin, Central District, Israel

The Chaim Sheba Medical Center /ID# 276745

Ramat Gan, Tel Aviv, Israel

Rambam Health Care Campus- Haifa /ID# 276746

Haifa, Israel

Ospedale Isola Tiberina - Gemelli Isola /ID# 277117

Rome, Roma, Italy

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

Candiolo, Torino, Italy

Hokkaido University Hospital /ID# 277240

Sapporo, Hokkaido, Japan

Kitasato University Hospital /ID# 277241

Sagamihara-shi, Kanagawa, Japan

National Cancer Center Hospital /ID# 277093

Chuo-Ku, Tokyo, Japan

Wakayama Medical University Hospital /ID# 277238

Wakayama, Wakayama, Japan

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

Guimarães, Braga District, Portugal

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

Loures, Lisbon District, Portugal

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

Senhora da Hora, Porto District, Portugal

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

Braga, Portugal

Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 277216

Porto, Portugal

National Cancer Center /ID# 277353

Goyang-si, Gyeonggido, South Korea

Chungbuk National University Hospital /ID# 277372

Cheongju-si, North Chungcheong, South Korea

Seoul National University Hospital /ID# 277373

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center /ID# 277371

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 277600

Seoul, Seoul Teugbyeolsi, South Korea

Hospital Universitario Virgen de la Victoria /ID# 277159

Málaga, Spain

Hospital Clinico Universitario de Valencia /ID# 277147

Valencia, Spain

Hospital Clinico Universitario Lozano Blesa /ID# 277154

Zaragoza, Spain

Changhua Christian Hospital /ID# 277145

Changhua, Taiwan

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

Kaohsiung City, Taiwan

Taichung Veterans General Hospital /ID# 277142

Taichung, Taiwan

Mackay Memorial Hospital /ID# 277146

Taipei, Taiwan

Taipei Veterans General Hospital /ID# 277141

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07155187