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New drug aimed at Hard-to-Treat lung cancer enters Mid-Stage trial

NCT ID NCT06568939

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 16, 2026 · Updated 13 times

Summary

This phase 2 trial is testing three different doses of an investigational drug called telisotuzumab vedotin in about 150 adults with a specific type of advanced lung cancer (non-small cell lung cancer that has high levels of a protein called c-Met and no EGFR mutation). The drug is designed to target and kill cancer cells while sparing healthy ones. Researchers will monitor safety, side effects, and whether the tumors shrink. The study is currently recruiting at sites worldwide.

What this could mean

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

Active substance
Telisotuzumab vedotin (a drug that targets cancer cells with high c-Met protein)
What this could lead to
If successful, this could provide a new treatment option for people with a specific type of lung cancer that has not responded to prior therapy.
What could go wrong
This is an early-phase trial with only 150 participants, so results may not apply to everyone. The drug can cause side effects like lung inflammation, nerve damage, and eye problems.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

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

Started

Jan 2025

Expected to finish

Feb 2028

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: * Projected life expectancy of at least 12 weeks. * Must have c-Met overexpressing non-small cell lung cancer (NSCLC) (defined as \>= 25% tumor cells with 3+ staining (high \[\>= 50% 3+\]; intermediate \[\>= 25% - \< 50%\]) as assessed by a Sponsor designated immunohistochemistry (IHC) laboratory * Must have histologically or cytologically documented NSCLC that is locally advanced or metastatic. * Must have a known epidermal growth factor receptor (EGFR) activating mutation status. * Actionable alterations in genes other than EGFR are permitted. * Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * Must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting, as stated in the protocol. * Must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC, as stated in the protocol. Exclusion Criteria: * Adenosquamous or neuroendocrine histology, or sarcomatoid features. * EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion mutations). * Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E. * Received prior docetaxel therapy. * Metastases to the central nervous system (CNS). Participants with CNS metastases are eligible only after adequate treatment (such as surgery or, radiotherapy, or drug therapy) is provided, as stated on the protocol. * History of other malignancies except those stated in the protocol. * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan, as noted in the protocol. * Unresolved clinically significant adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study. * Major surgery within 21 days prior to randomization. * Clinically significant condition(s) including but not limited to those listed in the protocol. * Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis. * Grade \>= 2 edema or lymphedema. * Grade \>= 2 ascites or pleural effusion. * Grade \>= 2 neuropathy. * Active uncontrolled bacterial or viral infection. * Active corneal disorder.

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Conditions

The condition(s) this trial relates to.

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

    79 sites in 7 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

  • Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931

    RECRUITING

    Nanning, Guangxi, 530021, China

  • Astera Cancer Care /ID# 272359

    RECRUITING

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

  • Beijing Chest Tumor Hospital /ID# 271935

    RECRUITING

    Beijing, Beijing Municipality, 101149, China

  • Cancer Care Associates Of York /ID# 270971

    RECRUITING

    York, Pennsylvania, 17403, United States

  • Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933

    RECRUITING

    Ürümqi, Xinjiang, 830011, China

  • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Cepen - Centro De Pesquisa E Ensino Em Oncologia De Santa Catarina /ID# 273204

    RECRUITING

    Florianópolis, Santa Catarina, 88020-210, Brazil

  • Clinical Hospital Center - Bezanijska Kosa /ID# 270558

    RECRUITING

    Belgrade, Beograd, 11080, Serbia

  • Clinical Research Alliance - Westbury /ID# 270455

    RECRUITING

    Westbury, New York, 11590, United States

  • Community Cancer Trials Of Utah /ID# 276598

    RECRUITING

    Ogden, Utah, 84405, United States

  • Comprehensive Hematology Oncology /ID# 270422

    RECRUITING

    St. Petersburg, Florida, 33701-4732, United States

  • FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 284816

    RECRUITING

    Oxnard, California, 93030, United States

  • FirstHealth of the Carolinas- Speciality Center /ID# 272924

    RECRUITING

    Pinehurst, North Carolina, 28374, United States

  • Florida Cancer Specialists - East /ID# 271993

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Florida Cancer Specialists - North /ID# 271995

    RECRUITING

    St. Petersburg, Florida, 33705, United States

  • Fujian Province Cancer Hospital /ID# 276178

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Fujieda Municipal General Hospital /ID# 277025

    RECRUITING

    Fujieda, Shizuoka, 426-0077, Japan

  • Genesis Healthcare System /ID# 273361

    RECRUITING

    Zanesville, Ohio, 43701, United States

  • Guthrie Robert Packer Hospital /ID# 270316

    RECRUITING

    Sayre, Pennsylvania, 18840, United States

  • Harbin Medical University Cancer Hospital /ID# 271665

    RECRUITING

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital /ID# 271927

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hokkaido University Hospital /ID# 277014

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • Hospital Alemao Oswaldo Cruz - Sao Paulo /ID# 272512

    RECRUITING

    São Paulo, 01323-020, Brazil

  • Hospital De Cancer De Pernambuco /ID# 276104

    RECRUITING

    Recife, Pernambuco, 50040-000, Brazil

  • Ictrials Pesquisa E Desenvolvimento /ID# 276681

    RECRUITING

    Curitiba, Paraná, 80510-130, Brazil

  • Illinois Cancer Specialists /ID# 274678

    RECRUITING

    Niles, Illinois, 60714, United States

  • Institute For Pulmonary Diseases Of Vojvodina /ID# 270559

    RECRUITING

    Kamenitz, Sremski Okrug, 21208, Serbia

  • Institute for Oncology and Radiology of Serbia /ID# 270561

    RECRUITING

    Belgrade, Beograd, 11000, Serbia

  • Ironwood Cancer and Research Center /ID# 276370

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Kaiser Permanente Moanalua Medical Center /ID# 272916

    RECRUITING

    Honolulu, Hawaii, 96819, United States

  • Kitasato University Hospital /ID# 277012

    RECRUITING

    Sagamihara-shi, Kanagawa, 252-0375, Japan

  • Kobe Minimally Invasive Cancer Center /ID# 277469

    RECRUITING

    Kobe, Hyōgo, 650-0046, Japan

  • Kurashiki Central Hospital /ID# 276995

    RECRUITING

    Kurashiki-shi, Okayama-ken, 710-8602, Japan

  • Liga Norte Riograndense Contra O Cancer /ID# 273183

    RECRUITING

    Natal, Rio Grande do Norte, 59075-740, Brazil

  • LinYi Cancer Hospital /ID# 272068

    RECRUITING

    Linyi, Shandong, 276001, China

  • Medical Oncology Associates - Spokane /ID# 277172

    RECRUITING

    Spokane, Washington, 99208, United States

  • Medical University of South Carolina /ID# 273272

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Meir Medical Center /ID# 270071

    RECRUITING

    Kefar Sava, Central District, 4428164, Israel

  • Memorial Hospital West /ID# 270313

    RECRUITING

    Pembroke Pines, Florida, 33028, United States

  • Memorial University Medical Center /ID# 272467

    COMPLETED

    Savannah, Georgia, 31404, United States

  • Mercy Health - Perrysburg Cancer Center /ID# 270536

    RECRUITING

    Perrysburg, Ohio, 43551, United States

  • Military Medical Academy /ID# 279873

    RECRUITING

    Belgrade, Beograd, 11000, Serbia

  • Montefiore Medical Center - Einstein Campus /ID# 277169

    RECRUITING

    The Bronx, New York, 10461, United States

  • Nagoya University Hospital /ID# 277010

    RECRUITING

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cancer Center Hospital East /ID# 277056

    RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cancer Centre Singapore /ID# 271499

    RECRUITING

    Singapore, Central Singapore, 169611, Singapore

  • National University Hospital /ID# 271700

    RECRUITING

    Singapore, 119074, Singapore

  • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • Nebraska Hematology-Oncology /ID# 272970

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • Northwest Georgia Oncology Centers /ID# 275374

    RECRUITING

    Marietta, Georgia, 30060, United States

  • Northwest Medical Specialties Tacoma /ID# 270534

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Ocala Oncology Center /ID# 273697

    RECRUITING

    Ocala, Florida, 34474, United States

  • Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 272513

    RECRUITING

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Rabin Medical Center. /ID# 270087

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Rambam Health Care Campus- Haifa /ID# 270078

    RECRUITING

    Haifa, 3109601, Israel

  • Regional Cancer Care Associates /ID# 270783

    RECRUITING

    Teaneck, New Jersey, 07666, United States

  • Renown Regional Medical Center /ID# 273535

    RECRUITING

    Reno, Nevada, 89502, United States

  • SCRI Oncology Partners /ID# 270162

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Saint Francis Cancer Center - Greenville /ID# 276368

    RECRUITING

    Greenville, South Carolina, 29607, United States

  • Sendai Kousei Hospital /ID# 277023

    RECRUITING

    Sendai, Miyagi, 981-0914, Japan

  • Shaare Zedek Medical Center /ID# 270095

    COMPLETED

    Jerusalem, 9103102, Israel

  • Springfield Clinic - First /ID# 272576

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Start Los Angeles /ID# 284999

    RECRUITING

    Los Angeles, California, 90025, United States

  • Suporte Nutricional e Quimioterapia LTDA - PRONUTRIR /ID# 273203

    RECRUITING

    Fortaleza, Ceará, 60810-180, Brazil

  • Texas Oncology - Dallas - Worth Street /ID# 278947

    RECRUITING

    Dallas, Texas, 75246, United States

  • Texas Oncology - Northeast Texas /ID# 272000

    RECRUITING

    Tyler, Texas, 75702, United States

  • The Chaim Sheba Medical Center /ID# 270068

    RECRUITING

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The First Affiliated Hospital of Nanchang University /ID# 271666

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • Union Hospital - Tongji Medical College /ID# 271668

    RECRUITING

    Wuhan, Hubei, 430022, China

  • University Cancer & Blood Center /ID# 270969

    RECRUITING

    Athens, Georgia, 30607, United States

  • University Clinical Center Kragujevac /ID# 275773

    RECRUITING

    Kragujevac, Sumadijski Okrug, 34000, Serbia

  • University Clinical Center Nis /ID# 270557

    RECRUITING

    Niš, Nisavski Okrug, 18300, Serbia

  • University Clinical Center Serbia /ID# 270808

    RECRUITING

    Belgrade, Beograd, 11000, Serbia

  • University of Arkansas for Medical Sciences /ID# 272923

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of Illinois Hospital and Health Sciences System /ID# 275345

    RECRUITING

    Chicago, Illinois, 60607, United States

  • University of Miyazaki Hospital /ID# 277020

    RECRUITING

    Miyazaki, Miyazaki, 889-1692, Japan

  • Valkyrie Clinical Trials /ID# 271322

    RECRUITING

    Los Angeles, California, 90067, United States

  • Virginia Cancer Specialists - Fairfax /ID# 272004

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Wakayama Medical University Hospital /ID# 276997

    RECRUITING

    Wakayama, Wakayama, 641-8510, Japan

  • Yale New Haven Hospital /ID# 271584

    RECRUITING

    New Haven, Connecticut, 06510, United States

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