Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04486833 | Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib | PHASE1 | RECRUITING | 158 | — | — | Sep 3, 2021 | Mar 1, 2029 | Jan 21, 2026 | 10 | United States |
RP2D, which will be the maximum tolerated dose (MTD) or, if the MTD is not defined by the safety data, RP2D will be determined based on an integrated assessment of all available clinical safety and preliminary efficacy data.
ORR (complete response \[CR\]+ partial response \[PR\]) according to RECIST using best overall response.
PFS from randomization to disease progression or death. Response according to RECIST.
| Arm | Type | Description |
|---|---|---|
| Investigational | EXPERIMENTAL | In Phase 1, Phase 2a and the investigational arm of Phase 2b, patients will receive their assigned dose of quaratusugene ozeplasmid (intravenous administration once every 21 days) plus osimertinib (80 mg fixed dose oral tablet taken daily starting on Day 1 through Day 21 of every 21-day treatment cycle) until disease progression or unacceptable toxicity. |
| Control | ACTIVE_COMPARATOR | In the control arm of Phase 2b, patients will receive platinum-based chemotherapy until disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| quaratusugene ozeplasmid | BIOLOGICAL | Quaratusugene ozeplasmid is an experimental non-viral immunogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, reestablishing pathways that promote cancer cell death and modulating the immune response against cancer cells. |
| osimertinib | DRUG | Osimertinib is a 3rd generation EGFR tyrosine kinase inhibitor (TKI) oral tablet administered daily, as indicated for treatment of patients with metastatic NSCLC whose tumors have EGFR genetic deletions or mutations. |
| Platinum-Based Chemotherapy | DRUG | Cisplatin and carboplatin are intravenously administered platinum agents that are combined with other cytotoxic chemotherapy agents such as pemetrexed. |
Inclusion Criteria: 1. Age ≥18 years. 2. Histologically or cytologically documented NSCLC. 3. Stage III or IV NSCLC or recurrent NSCLC that is not potentially curable by radiotherapy or surgery. 4. The NSCLC must be epidermal growth factor receptor (EGFR) mutation positive-positive based on results...