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 (REQORSA™, GPX-001) has been shown to modulate the immune system

Key Eligibility Criteria:

• Histologically/cytologically documented NSCLC
• Stage III/IV NSCLC or recurrent NSCLC that is not potentially curable by radiotherapy/surgery whether or not patient has received prior chemotherapy
• EGFR mutation-positive as detected by an FDA-approved test
• Achieved clinical response to osimertinib for ≥4 months
• Radiological progression on/after treatment with osimertinib with asymptomatic/symptomatic disease with limited metastasis
• ECOG PS of 0 or 1
• Unable to tolerate osimertinib treatment excluded
• Progressing patients who are symptomatic and have >5 metastasis excluded
• Prior gene therapy excluded