WithdrawnPhase 3

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

Stopped: Strategic considerations

0Started 2024-05-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must have metastatic/locally advanced non-squamous NSCLC with documented epidermal growth factor receptor (EGFR) mutation del19 or L858R, with or without T790M mutation, and no identified EGFR mutations known to confer resistance to osimertinib (for instance C797S). * Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. * Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * Must have measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1. * Must have received one prior regimen in the metastatic setting, consisting of a third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKi) (for instance, osimertinib). Participant must have had one disease progression while on this third generation EGFR TKi. Prior-rechallenge with a third generation EGFR TKi is not allowed. Treatment with a first or second generation EGFR TKi immediately prior to the third generation EGFR TKi will not count as one prior regimen. Those who have received a third generation EGFR TKi as adjuvant therapy, and have progressed within 6 months of the last dose of treatment will be eligible (i.e., considered as having received a third generation EGFR TKi in the metastatic setting). * Must be considered appropriate for platinum therapy based on the assessment of the treating physician. * Participants with metas…

What they're measuring

PFS in the Population of Participants with no Central Nervous System (CNS) Metastases at Baseline

Timeframe: Up to Approximately 41 Months

Trial details

NCT IDNCT06093503

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-11