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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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 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.
Cedars-Sinai Cancer at Beverly Hills (THO)
Beverly Hills, California, United States
RECRUITINGCedars-Sinai Cancer at The Angeles Clinic and Research Institute
Los Angeles, California, United States
RECRUITINGCedars-Sinai Cancer at SOCC
Los Angeles, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGCedars-Sinai Cancer at Hunt Cancer Center - TMPNCC
Torrance, California, United States
RECRUITINGThe number of adverse events and dose-limiting toxicities to find the Recommended Phase 2 Dose (RP2D) of combination of osimertinib with carotuximab in treatment of advanced, EGFR-mutated non-small cell lung cancer.
The number of adverse events are graded by NCI CTCAE v5.0. The number of these dose-limiting toxicities (DLTs) experienced within the first treatment cycle (28 days) will be assessed to determine the RP2D.
Time frame: 4 weeks
Objective response rate
Proportion of participants with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Time frame: Assessed from baseline until the date of first documented progression, which is the end of treatment (EOT), assessed up to 2 years.
Disease control rate
Proportion of participants with confirmed CR, PR, or stable disease (SD) per RECIST v.1.1
Time frame: Assessed from baseline until EOT, up to 2 years.
Duration of response
Length of time from treatment response to progressive disease (PD) per RECIST v.1.1or death.
Time frame: From baseline to first documentation of PD or death, whichever came first. Assessed up to 2 years.
Progression free survival.
From Cycle 1 Day 1 (C1D1) until first documentation of PD per RECIST v.1.1 or death due to any cause.
Time frame: Assessed from the time of treatment initiation (C1D1) until first documentation of progression, or death due to any cause, whichever came first. Assessed up to 2 years. One treatment cycle is 28 days.
Biomarkers using tumor tissue and serial ctDNA for mutations.
ctDNA will be evaluated for genomic alterations.
Time frame: From baseline until disease progression, or death, whichever came first. Assessed up to 2 years.
Biomarkers of response to the combination using tumor tissue and serial ctDNA.
ctDNA will be evaluated to correlate with response.
Time frame: From baseline until disease progression, or death, whichever came first. Assessed up to 2 years.
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