Osimertinib for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cedars-Sinai Medical Center, Los Angeles, CA
Lung Cancer+3 More
Osimertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of two drugs, osimertinib and carotuximab, to treat advanced EGFR-mutated non-small cell lung cancer. The goal is to find the maximum tolerated dose of the combination by measuring the number of dose-limiting toxicities. Secondary objectives include evaluating the rate of objective response, duration of response, progression-free survival, and disease control rate. Osimertinib is used to treat lung cancer and has been previously approved by the FDA for a different condition. This treatment is free for patients in this trial, and they will not receive a placebo.

Eligible Conditions

  • Lung Cancer
  • Lung Cancers
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lung Cancer

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Assessed from baseline until EOT, up to 2 years.

4 weeks
The 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.
Year 2
Disease control rate
Year 2
Objective response rate
Year 2
Progression free survival.
Year 2
Duration of response
Year 2
Biomarkers of response to the combination using tumor tissue and serial ctDNA.
Biomarkers using tumor tissue and serial ctDNA for mutations.

Trial Safety

Safety Progress

1 of 3

Other trials for Lung Cancer

Trial Design

1 Treatment Group

Osimertinib with Carotuximab
1 of 1
Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Osimertinib · No Placebo Group · Phase 1

Osimertinib with CarotuximabExperimental Group · 2 Interventions: Carotuximab, Osimertinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~770

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed from baseline until eot, up to 2 years.
Closest Location: Cedars-Sinai Medical Center · Los Angeles, CA
Photo of Los Angeles 1Photo of Los Angeles 2Photo of Los Angeles 3
2006First Recorded Clinical Trial
0 TrialsResearching Lung Cancer
516 CompletedClinical Trials

Who is running the clinical trial?

Enviro Therapeutics, Inc.UNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled
Karen Reckamp, MD, MSLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have progressive disease on at least one prior EGFR TKI.
You have measurable disease by RECIST 1.1.\n
Patients must have completed prior chemotherapy ≥ 3 weeks or radiotherapy ≥ 2 weeks prior to receiving study drugs.
You have progressive disease on osimertinib or other prior EGFR TKIs.
Patients with untreated brain metastases are allowed provided that the patient is clinically asymptomatic and stable.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.