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

Non-Small Cell Lung Cancer Clinical Trial

Official title:
Phase 3, Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Combined With Osimertinib vs Platinum-Based Chemotherapy in Subjects With c-Met Overexpressing (OE) EGFR Mutant, Locally Advanced/Metastatic Non-Squamous NSCLC After a First Progression on Prior Third Generation EGFR TKi Treatment

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06093503
Study type	Interventional
Source	AbbVie
Contact	ABBVIE CALL CENTER
Phone	844-663-3742
Email	abbvieclinicaltrials@abbvie.com
Status	Not yet recruiting
Phase	Phase 3
Start date	May 31, 2024
Completion date	April 11, 2028

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