Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein - Trial NCT06093503
Access comprehensive clinical trial information for NCT06093503 through Pure Global AI's free database. This Phase 3 trial is sponsored by AbbVie and is currently Not yet recruiting. The study focuses on Non-Small Cell Lung Cancer. Target enrollment is 250 participants.
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Study Focus
Sponsor & Location
AbbVie
Timeline & Enrollment
Phase 3
May 31, 2024
Apr 11, 2028
Primary Outcome
PFS in the Population of Participants with no Central Nervous System (CNS) Metastases at Baseline
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. The purpose of this study is to assess how
 telisotuzumab vedotin in combination with osimertinib affects the disease state compared to
 standard of care in adult participants with locally advanced/metastatic non-squamous NSCLC
 that has a mutation in the epidermal growth factor receptor (EGFR) gene and that
 overexpresses the c-Met protein. Change in disease activity will be assessed.
 
 Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC
 that overexpresses the c-Met protein. Participants are randomly placed in one of the two
 groups to receive telisotuzumab vedotin and osimertinib or standard of care chemotherapy.
 Approximately 250 adult participants with locally advanced/metastatic non-squamous NSCLC that
 has a mutation in the EGFR gene and that overexpresses the c-Met protein will be enrolled in
 the study in approximately 180 sites worldwide.
 
 Participants will receive intravenous telisotuzumab vedotin every 2 weeks in combination with
 oral osimertinib tablets daily or standard of care chemotherapy (carboplatin/pemetrexed or
 cisplatin/pemetrexed as prescribed by the physician). Overall duration of the study is
 estimated to be approximately 47 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 a hospital or
 clinic. The effect of the treatment will be checked by medical assessments, blood tests,
 checking for side effects and completing questionnaires.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06093503
Non-Device Trial