AEB1102

A Phase 1/2 Study of Pegzilarginase (AEB1102, Co-ArgI-PEG) in Combination With Pembrolizumab in the Treatment of Patients With Extensive Disease (ED) Small Cell Lung Cancer (SCLC)

Objective

The main purpose of this Phase 1/2 study is to determine the safety and efficacy of pegzilarginase in combination with pembrolizumab in patients with ED-SCLC who have relapsed or progressive disease on or within 6 months of platinum-based chemotherapy.

Eligibility

  • Have histologically or cytologically confirmed SCLC that meets:
    • Extensive disease per criteria of the International Association for the Study of Lung Cancer (IASLC)-American Joint Committee on Cancer (AJCC) TNM staging system
    • Have not tolerated or have progressed or relapsed on or within 6 months of platinum-based chemotherapy
  • Have a performance status of ≤ 1 on the ECOG Performance Scale
  • Have measurable disease based on RECIST 1.1
  • Willing to undergo core needle or incisional biopsy to obtain fresh tumor tissue specimens
  • Demonstrate adequate organ function as evidenced by laboratory testing

NCT ID

NCT03371979