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RECRUITING
NCT05401110
PHASE1

Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer

Sponsor: Karen Reckamp, MD, MS

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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