Non-Small Cell Lung CancerPhase 2NCT06568939
A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Telisotuzumab Vedotin in people with Non-Small Cell Lung Cancer and c-MET, run by AbbVie at 83 sites in 7 countries.
Trial summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. 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 Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 83 sitesin 7 countries
- Study dates
- 20 Jan 2025to Feb 2028
- Phase
- Phase 2
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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
83 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
83 sites in 7 countries
United States41 sites, 39 recruiting
- Recruiting
University Cancer and Blood Center /ID# 270969
Athens, Georgia, 30607
- Recruiting
Ironwood Cancer and Research Center /ID# 276370
Chandler, Arizona, 85224
- Recruiting
Medical University of South Carolina /ID# 273272
Charleston, South Carolina, 29425
- Recruiting
University of Illinois Hospital and Health Sciences System /ID# 275345
Chicago, Illinois, 60607
- Recruiting
Texas Oncology - Dallas - Worth Street /ID# 278947
Dallas, Texas, 75246
- Recruiting
Astera Cancer Care /ID# 272359
East Brunswick, New Jersey, 08816-4096
- Recruiting
Virginia Cancer Specialists - Fairfax /ID# 272004
Fairfax, Virginia, 22031
- Recruiting
Saint Francis Cancer Center - Greenville /ID# 276368
Greenville, South Carolina, 29607
- Recruiting
Kaiser Permanente Moanalua Medical Center /ID# 272916
Honolulu, Hawaii, 96819
- Recruiting
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
Jacksonville, Florida, 32256
- Recruiting
Nebraska Hematology-Oncology /ID# 272970
Lincoln, Nebraska, 68506
- Recruiting
University of Arkansas for Medical Sciences /ID# 272923
Little Rock, Arkansas, 72205
- Recruiting
Start Los Angeles /ID# 284999
Los Angeles, California, 90025
- Recruiting
Valkyrie Clinical Trials /ID# 271322
Los Angeles, California, 90067
- Recruiting
Northwest Georgia Oncology Centers /ID# 275374
Marietta, Georgia, 30060
- Recruiting
SCRI Oncology Partners /ID# 270162
Nashville, Tennessee, 37203
- Completed
Yale New Haven Hospital /ID# 271584
New Haven, Connecticut, 06510
- Recruiting
Illinois Cancer Specialists /ID# 274678
Niles, Illinois, 60714
- Recruiting
Ocala Oncology Center /ID# 273697
Ocala, Florida, 34474
- Recruiting
Community Cancer Trials Of Utah /ID# 276598
Ogden, Utah, 84405
- Recruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
Omaha, Nebraska, 68130
- Recruiting
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 284816
Oxnard, California, 93030
- Recruiting
Memorial Hospital West /ID# 270313
Pembroke Pines, Florida, 33028
- Recruiting
OSF St. Francis Medical Center /ID# 281591
Peoria, Illinois, 61637-0001
- Recruiting
Mercy Health - Perrysburg Cancer Center /ID# 270536
Perrysburg, Ohio, 43551
- Recruiting
FirstHealth of the Carolinas- Speciality Center /ID# 272924
Pinehurst, North Carolina, 28374
- Recruiting
Renown Regional Medical Center /ID# 273535
Reno, Nevada, 89502
- Completed
Memorial University Medical Center /ID# 272467
Savannah, Georgia, 31404
- Recruiting
Guthrie Robert Packer Hospital /ID# 270316
Sayre, Pennsylvania, 18840
- Recruiting
Medical Oncology Associates - Spokane /ID# 277172
Spokane, Washington, 99208
- Recruiting
Springfield Clinic - First /ID# 272576
Springfield, Illinois, 62702
- Recruiting
Comprehensive Hematology Oncology /ID# 270422
St. Petersburg, Florida, 33701-4732
- Recruiting
Florida Cancer Specialists - North /ID# 271995
St. Petersburg, Florida, 33705
- Recruiting
Northwest Medical Specialties Tacoma /ID# 270534
Tacoma, Washington, 98405
- Recruiting
Regional Cancer Care Associates /ID# 270783
Teaneck, New Jersey, 07666
- Recruiting
Montefiore Medical Center - Einstein Campus /ID# 277169
The Bronx, New York, 10461
- Recruiting
Texas Oncology - Northeast Texas /ID# 272000
Tyler, Texas, 75702
- Recruiting
Florida Cancer Specialists - East /ID# 271993
West Palm Beach, Florida, 33401
- Recruiting
Clinical Research Alliance (SMO/Network/Consortium) /ID# 270455
Westbury, New York, 11590
- Recruiting
Cancer Care Associates Of York /ID# 270971
York, Pennsylvania, 17403
- Recruiting
Genesis Healthcare System /ID# 273361
Zanesville, Ohio, 43701
China10 sites, 10 recruiting
- Recruiting
Beijing Chest Tumor Hospital /ID# 271935
Beijing, Beijing Municipality, 101149
- Recruiting
Fujian Province Cancer Hospital /ID# 276178
Fuzhou, Fujian, 350014
- Recruiting
Harbin Medical University Cancer Hospital /ID# 271665
Harbin, Heilongjiang, 150081
- Recruiting
LinYi Cancer Hospital /ID# 272068
Linyi, Shandong, 276001
- Recruiting
The First Affiliated Hospital of Nanchang University /ID# 271666
Nanchang, Jiangxi, 330006
- Recruiting
Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931
Nanning, Guangxi, 530021
- Recruiting
Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933
Ürümqi, Xinjiang, 830011
- Recruiting
Union Hospital - Tongji Medical College /ID# 271668
Wuhan, Hubei, 430022
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928
Xi'an, Shaanxi, 710061
- Recruiting
Henan Cancer Hospital /ID# 271927
Zhengzhou, Henan, 450008
Japan10 sites, 10 recruiting
- Recruiting
Fujieda Municipal General Hospital /ID# 277025
Fujieda, Shizuoka, 426-0077
- Recruiting
National Cancer Center Hospital East /ID# 277056
Kashiwa-shi, Chiba, 277-8577
- Recruiting
Kobe Minimally Invasive Cancer Center /ID# 277469
Kobe, Hyōgo, 650-0046
- Recruiting
Kurashiki Central Hospital /ID# 276995
Kurashiki-shi, Okayama-ken, 710-8602
- Recruiting
University of Miyazaki Hospital /ID# 277020
Miyazaki, Miyazaki, 889-1692
- Recruiting
Nagoya University Hospital /ID# 277010
Nagoya, Aichi-ken, 466-8560
- Recruiting
Kitasato University Hospital /ID# 277012
Sagamihara-shi, Kanagawa, 252-0375
- Recruiting
Hokkaido University Hospital /ID# 277014
Sapporo, Hokkaido, 060-8648
- Recruiting
Sendai Kousei Hospital /ID# 277023
Sendai, Miyagi, 981-0914
- Recruiting
Wakayama Medical University Hospital /ID# 276997
Wakayama, Wakayama, 641-8510
Brazil8 sites, 8 recruiting
- Recruiting
Cto - Centro De Tratamento Oncologico /ID# 276699
Belém, Pará, 66063-495
- Recruiting
Ictrials Pesquisa E Desenvolvimento /ID# 276681
Curitiba, Paraná, 80510-130
- Recruiting
Cepen - Centro De Pesquisa E Ensino Em Oncologia De Santa Catarina /ID# 273204
Florianópolis, Santa Catarina, 88020-210
- Recruiting
Suporte Nutricional e Quimioterapia LTDA - PRONUTRIR /ID# 273203
Fortaleza, Ceará, 60810-180
- Recruiting
Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 272513
Ijuí, Rio Grande do Sul, 98700-000
- Recruiting
Liga Norte Riograndense Contra O Cancer /ID# 273183
Natal, Rio Grande do Norte, 59075-740
- Recruiting
Hospital De Cancer De Pernambuco /ID# 276104
Recife, Pernambuco, 50040-000
- Recruiting
Hospital Alemao Oswaldo Cruz - Sao Paulo /ID# 272512
São Paulo, 01323-020
Serbia7 sites, 7 recruiting
- Recruiting
Institute for Oncology and Radiology of Serbia /ID# 270561
Belgrade, Beograd, 11000
- Recruiting
Military Medical Academy /ID# 279873
Belgrade, Beograd, 11000
- Recruiting
University Clinical Center Serbia /ID# 270808
Belgrade, Beograd, 11000
- Recruiting
Clinical Hospital Center - Bezanijska Kosa /ID# 270558
Belgrade, Beograd, 11080
- Recruiting
Institute For Pulmonary Diseases Of Vojvodina /ID# 270559
Kamenitz, Sremski Okrug, 21208
- Recruiting
University Clinical Center Kragujevac /ID# 275773
Kragujevac, Sumadijski Okrug, 34000
- Recruiting
University Clinical Center Nis /ID# 270557
Niš, Nisavski Okrug, 18300
Israel5 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus- Haifa /ID# 270078
Haifa, 3109601
- Completed
Shaare Zedek Medical Center /ID# 270095
Jerusalem, 9103102
- Recruiting
Meir Medical Center /ID# 270071
Kefar Sava, Central District, 4428164
- Recruiting
Rabin Medical Center. /ID# 270087
Petah Tikva, Central District, 4941492
- Recruiting
The Chaim Sheba Medical Center /ID# 270068
Ramat Gan, Tel Aviv, 5265601
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital /ID# 271700
Singapore, Central Singapore, 119074
- Recruiting
National Cancer Centre Singapore /ID# 271499
Singapore, Central Singapore, 169611
About this study
Official title: A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 80 to 90 sites worldwide.
Read more
Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration.
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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
- Conditions
- Non-Small Cell Lung Cancer, c-MET
- Being tested
- Telisotuzumab Vedotin
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Telisotuzumab Vedotin, ABBV-399, TeliMET NSCLC-04
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telisotuzumab VedotinDrug
Also called ABBV-399
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| Telisotuzumab Vedotin Dose A | Experimental | Participants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration. Receives: Drug: Telisotuzumab Vedotin |
| Telisotuzumab Vedotin Dose B | Experimental | Participants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration. Receives: Drug: Telisotuzumab Vedotin |
| Telisotuzumab Vedotin Dose C | Experimental | Participants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration. Receives: Drug: Telisotuzumab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2)
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Measured: Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent Interstitial Lung Disease (ILD)
ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication (any-grade and Grade >= 2).
Measured: Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent Peripheral Neuropathy
Peripheral neuropathy is defined by peripheral neuropathy SMQ (narrow) (any-grade and Grade >= 2)
Measured: Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent Ocular Surface Disorders
Treatment-emergent ocular surface disorders defined by corneal epitheliopathy company MedDRA query (CMQ) (any-grade and Grade >= 2).
Measured: Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent AEs Leading to Study Drug Discontinuation
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Measured: Up to Approximately 3 Years
Percentage of Participants with Grade 5 Treatment-Emergent AEs
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Measured: Up to Approximately 3 Years
Objective Response (OR) by Blinded Independent Central Review (BICR)
OR will be defined as achieving confirmed complete response (CR) or confirmed partial response (PR) based on response evaluation criteria in solid tumors (RECIST), version 1.1.
Measured: Up to Approximately 3 Years
Secondary outcomes (9)
Concentrations of Telisotuzumab Vedotin Conjugate in Serum
Concentrations of telisotuzumab vedotin conjugate in serum.
Measured: Up to 26 Weeks
Concentrations of Monomethylauristatin E (MMAE) Payload in Plasma
Concentrations of MMAE payload in plasma.
Measured: Up to 26 Weeks
Percentage of Participants with Antidrug Antibodies (ADAs) of Telisotuzumab Vedotin
Percentage of participants with ADAs of telisotuzumab vedotin.
Measured: Up to 26 Weeks
Percentage of Participants with Neutralizing Antidrug Antibodies (nADAs) of Telisotuzumab Vedotin
Percentage of participants with nADAs of telisotuzumab vedotin.
Measured: Up to 26 Weeks
Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in patients participating in cancer clinical trials. PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0/1 for absent/present).
Measured: Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G)
The GP5 item ("I am bothered by side effects of treatment") of FACT-G is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on participants.
Measured: Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
Duration of Response (DoR) by BICR
DoR is defined for confirmed responders as the time from the participants' initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause.
Measured: Up to Approximately 3 Years
Progression-Free Survival (PFS) by BICR
PFS will be defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause.
Measured: Up to Approximately 3 Years
Overall Survival (OS)
OS will be defined as the time from randomization to death from any cause.
Measured: Up to Approximately 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start20 Jan 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568939
- Sponsor's protocol ID
- M25-274
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2024
- Last updated
- 22 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.