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Telisotuzumab Vedotin

Phase 3

Non Small Cell Lung Cancer | Monoclonal antibody | Oncology |AbbVie Inc.|Last Updated: Sep 2, 2026

Target and mechanism

Molecular targetMET
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment768

FDA Designations

No designations recorded

Clinical trial landscape

Telisotuzumab Vedotin · 3 trials · 2 indications

Phase 3 1Phase 2 2
NCT04928846A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)Non Small Cell Lung Cancer
RECRUITING768 Analytics
PHASE3RECRUITING
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
Up to approximately 39 months

PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per BICR or death from any cause.

Overall Survival (OS)
Up to approximately 39 months

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

Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2)
Up to Approximately 3 Years

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.

Percentage of Participants with Treatment-Emergent Interstitial Lung Disease (ILD)
Up to Approximately 3 Years

ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication (any-grade and Grade \>= 2).

Percentage of Participants with Treatment-Emergent Peripheral Neuropathy
Up to Approximately 3 Years

Peripheral neuropathy is defined by peripheral neuropathy SMQ (narrow) (any-grade and Grade \>= 2)

Percentage of Participants with Treatment-Emergent Ocular Surface Disorders
Up to Approximately 3 Years

Treatment-emergent ocular surface disorders defined by corneal epitheliopathy company MedDRA query (CMQ) (any-grade and Grade \>= 2).

Percentage of Participants with Treatment-Emergent AEs Leading to Study Drug Discontinuation
Up to Approximately 3 Years

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.

Percentage of Participants with Grade 5 Treatment-Emergent AEs
Up to Approximately 3 Years

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.

Objective Response (OR) by Blinded Independent Central Review (BICR)
Up to Approximately 3 Years

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.

Overall Response Rate (ORR) (Stage 1 and Stage 2)
Up to approximately 3 years

ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Number of Participants with Adverse Events (Alternate dose cohort)
Up to approximately 3 years

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Secondary Endpoints

Objective Response Rate (ORR), per BICR.
Up to approximately 58.25 months
Duration of Response (DoR), per BICR
Up to approximately 58.25 months
PFS per Investigator Assessment
Up to approximately 58.25 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Telisotuzumab VedotinEXPERIMENTALParticipants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
DocetaxelACTIVE_COMPARATORParticipants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.
Telisotuzumab Vedotin Dose AEXPERIMENTALParticipants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration.
Telisotuzumab Vedotin Dose BEXPERIMENTALParticipants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration.
Telisotuzumab Vedotin Dose CEXPERIMENTALParticipants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration.

Interventions

NameTypeDescription
Telisotuzumab VedotinBIOLOGICALIntravenous (IV) Infusion
DocetaxelDRUGIV Infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites317

Inclusion Criteria: * Projected life expectancy of at least 12 weeks. * Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay. * Archival or fresh tumor materia...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaColombiaCzechiaDenmarkFranceGermanyGreeceIsraelItalyJapanMexicoNetherlandsPolandPortugalRomaniaSlovakiaSouth AfricaSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)United KingdomSerbiaSingaporeHungaryIrelandPuerto RicoRussiaSwitzerland
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Non Small Cell Lung Cancer")

Recent Changes (Last 90 Days)

LOWSep 2, 2026NCT06568939lastUpdatePostDate: changed
LOWSep 2, 2026NCT06568939lastUpdatePostDate: changed
LOWSep 2, 2026NCT06568939lastUpdatePostDate: changed
LOWAug 14, 2026NCT06568939lastUpdatePostDate: changed
LOWAug 14, 2026NCT06568939lastUpdatePostDate: changed
LOWJul 28, 2026NCT04928846lastUpdatePostDate: changed
LOWJul 28, 2026NCT04928846lastUpdatePostDate: changed
LOWJul 24, 2026NCT06568939lastUpdatePostDate: changed
LOWJul 24, 2026NCT06568939lastUpdatePostDate: changed
MEDIUMJul 17, 2026NCT04928846Enrollment: 698 → 768
MEDIUMJul 17, 2026NCT04928846Enrollment: 698 → 768
MEDIUMJul 17, 2026NCT04928846Enrollment: 698 → 768
LOWJul 6, 2026NCT06568939lastUpdatePostDate: changed
LOWJul 6, 2026NCT06568939lastUpdatePostDate: changed
LOWJun 29, 2026NCT06568939lastUpdatePostDate: changed
LOWJun 29, 2026NCT06568939lastUpdatePostDate: changed
LOWJun 26, 2026NCT06568939lastUpdatePostDate: changed
LOWJun 26, 2026NCT06568939lastUpdatePostDate: changed
LOWJun 24, 2026NCT06568939lastUpdatePostDate: changed
LOWJun 24, 2026NCT06568939lastUpdatePostDate: changed

Frequently asked questions about Telisotuzumab Vedotin

What is Telisotuzumab Vedotin used for?

Telisotuzumab Vedotin is an investigational monoclonal antibody being studied for the treatment of non-small cell lung cancer (NSCLC), specifically in adult patients with previously treated non-squamous NSCLC. It is currently in Phase 3 clinical development.

How does Telisotuzumab Vedotin work?

Telisotuzumab Vedotin is a monoclonal antibody, classified as an antibody drug conjugate. It is designed to target and deliver a cytotoxic agent to cancer cells. The drug is being evaluated as a monotherapy in clinical trials for non-small cell lung cancer.

Who is developing Telisotuzumab Vedotin?

Telisotuzumab Vedotin is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with previously treated non-small cell lung cancer.

What phase is Telisotuzumab Vedotin in?

Telisotuzumab Vedotin is in Phase 3 clinical development. It is being studied in a randomized, active-controlled trial comparing it to docetaxel in adult participants with previously treated non-squamous non-small cell lung cancer. The drug is not yet approved and remains investigational.

What clinical trials is Telisotuzumab Vedotin in?

Telisotuzumab Vedotin is being evaluated in multiple trials. NCT04928846 is a Phase 3 study comparing it to docetaxel in non-squamous NSCLC. NCT03539536 is a Phase 2 study in c-Met+ NSCLC. NCT06568939 is a Phase 2 pharmacokinetic study in non-squamous NSCLC.

Is Telisotuzumab Vedotin the same as ABBV-399?

Yes, Telisotuzumab Vedotin is also known as ABBV-399. Clinical trial records refer to the drug by both names, with ABBV-399 used in earlier study titles and Telisotuzumab Vedotin used in more recent trial documentation.