Clinical Trial

A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination with Osimertinib in Patients with Advanced, EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer who have Progressed after Treatment with Osimertinib (ONC-003)

MOA: Quaratusugene ozeplasmid is a nanoparticle encapsulating an optimized TUSC2 expression plasmid. Decreased expression of TUSC2 is associated with worse OS.

Key Eligibility Criteria:

• Unresectable stage III or IV NSCLC
• EGFR mutation-positive
• Phase 2: measurable disease per RECIST 1.1.
  • Phase 2a:
    • Cohort 1 must have progression on osimertinib alone
    • Cohort 2 must have progression after treatment with osimertinib, pemetrexed and a platin or single agent osimertinib followed by combination pemetrexed and a platin with or without osimertinib
  • Phase 2b: osimertinib treatment must be the only prior systemic treatment.