drugset / Trial / NCT05401110
Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to examine the combination of osimertinib and carotuximab to assess the safety and find the recommended dose for treatment of advanced EGFR-mutated non-small cell lung cancer (NSCLC). Safety and tolerability will be measured by the number of dose-limiting toxicities, according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5, to find the maximum tolerated dose. The secondary objectives include evaluating the rate of objective response rate, duration of response, progression-free survival, and disease control rate, along with assessing biomarkers through tumor tissue and circulating tumor DNA.
Timeline
- Start
- 2023-09-15
- Primary completion
- 2028-01
- Completion
- 2029-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carotuximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Carotuximab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Osimertinib | Small molecule | 40 mg | Oral |
| Subject | Osimertinib | Small molecule | 80 mg | Oral |