A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan as a monotherapy or in combination with

Trial Details

NCT ID
NCT07155187
Phase
PHASE2 / PHASE3
Sponsor
AbbVie
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Telisotuzumab Adizutecan
  • Standard of Care
  • Osimertinib
Locations (sample)
  • Springdale, Arkansas, United States|36.18674,-94.12881
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Rockledge, Florida, United States|28.35084,-80.72533

Key Eligibility Criteria

  • Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with document…
  • Provide recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If rece…
  • Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced…
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

For full eligibility, visit ClinicalTrials.gov.

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