Clinical Trial

Title: A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination with Osimertinib versus Osimertinib Monotherapy or Osimertinib in Combination with Platinum based Chemotherapy as First-Line Therapy in Patients with EGFR Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer

MOA: Izalontamab Brengitecan (BMS 986507) is an ADC that targets both EGFR and HER3 while delivering a topoisomerase I payload

Key Eligibility:

• Histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally
  advanced (Stage IIIB or IIIC) or metastatic (Stage IVA or IVB), or recurrent disease not
  amenable to curative surgery or definitive radiotherapy and requiring systemic treatment
  • Tumors with mixed adenosquamous histology may be eligible if the predominant histology is
    non-squamous and the patient is considered appropriate for EGFR-TKI-based therapy, and
    where applicable, pemetrexed-based therapy
• Documented evidence of an EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R
  substitution) determined by local testing
  • For patients without prior EGFR mutation results, central testing must confirm eligibility prior to
    randomization
• Fresh or FFPE tumor tissue (FFPE block or slides) must be submitted for retrospective
  confirmation or prospective (if local isn’t available) central testing of EGFR mutation status
• Pt must have measurable extracranial disease per RECIST v1.1
• Prior neoadjuvant/adjuvant plt-based chemo (administered ≥ 4 weeks before randomization) and
  immunotherapy (administered ≥ 8 weeks before randomization) are allowed; however, for
  patients with recurrence 12 months after completion of plt therapy are not eligible for plt-based
  treatment in the control arm
• Pts with unstable, symptomatic, or uncontrolled CNS metastases, including brain leptomeningeal
  disease, and/or spinal cord compression are excluded
• Pts with prior treatment with an EGFR-TKI, or with iza-bren, or any antibody and/or any ADC
  targeting EGFR and/or HER3, or any drug containing a topoisomerase I inhibitor are excluded