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Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
Sponsor: Karen Reckamp, MD, MS
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.
Official title: IIT2021-12-Reckamp-Osi105: Phase I Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-09-15
Completion Date
2029-01
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
Osimertinib
Osimertinib given by mouth daily at 40mg or 80mg depending on the starting dose level assigned per investigator. Therapy will continue until disease progression, patient withdrawal, or treatment intolerance.
Carotuximab
Carotuximab is administered intravenously weekly for the first 4 weeks, then every 2 weeks at 10mg/kg or 15 mg/kg depending on the starting dose level assigned per investigator. Therapy will continue until disease progression, patient withdrawal, or treatment intolerance.
Locations (5)
Cedars-Sinai Cancer at Beverly Hills (THO)
Beverly Hills, California, United States
Cedars-Sinai Cancer at The Angeles Clinic and Research Institute
Los Angeles, California, United States
Cedars-Sinai Cancer at SOCC
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Cedars-Sinai Cancer at Hunt Cancer Center - TMPNCC
Torrance, California, United States