RecruitingPhase 1NCT05401110

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

IIT2021-12-Reckamp-Osi105: Phase I Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer


Sponsor

Karen Reckamp, MD, MS

Enrollment

60 participants

Start Date

Sep 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two targeted drugs — osimertinib and carotuximab — can improve outcomes in people with advanced lung cancer driven by EGFR mutations, including those whose cancer has stopped responding to osimertinib alone. **You may be eligible if...** - You have been diagnosed with Stage IV or metastatic non-squamous non-small cell lung cancer (NSCLC) with an EGFR activating mutation - Your cancer has progressed on at least one prior EGFR-targeted therapy, or specifically on osimertinib - Your overall health allows you to participate in a clinical trial **You may NOT be eligible if...** - You have active brain metastases that are not stable - You have significant heart problems, including a prolonged QT interval - You are on blood thinners or have active bleeding - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOsimertinib

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.

DRUGCarotuximab

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

View Full Details on ClinicalTrials.gov

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NCT05401110


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