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NCT04928846PHASE3RECRUITING

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)

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Sponsor: AbbVie

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Non Small Cell Lung Cancer
Interventions
Telisotuzumab Vedotin, Docetaxel
Enrollment
698 participants
Primary completion
Mar 2028
Study completion
Mar 2028
First posted
Jun 2021
Last updated
May 2026

Primary Endpoints (CT.gov)

Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)

Time frame: Up to approximately 39 months

Overall Survival (OS)

Time frame: Up to approximately 39 months

Secondary Endpoints

Objective Response Rate (ORR), per BICR.

Duration of Response (DoR), per BICR

PFS per Investigator Assessment

Eligibility Criteria

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 material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. * If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China). * A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic. * A known epidermal growth factor receptor (EGFR) activating mutation status. \-- Participants with actionable EGFR activating mu

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov