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Brief Title: Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
Official Title: IIT2021-12-Reckamp-Osi105: Phase I Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
Study ID: NCT05401110
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Karen Reckamp, MD, MS
Affiliation: Cedars-Sinai Medical Center
Role: PRINCIPAL_INVESTIGATOR