← Back to Search

Monoclonal Antibodies

Osimertinib + Carotuximab for Lung Cancer

Phase 1

Recruiting

Research Sponsored by Karen Reckamp, MD, MS

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2

If the subject's most recent line of therapy is treatment with osimertinib, then all adverse events must be resolved to Grade 2 or better

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed from baseline until eot, up to 2 years.

Awards & highlights

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.

Who is the study for?

This trial is for adults with advanced non-squamous NSCLC that has specific EGFR mutations. Participants must have measurable disease, may have brain metastases if stable and asymptomatic, and should not have had recent major surgery or other cancer treatments. They need to agree to use contraception and be able to follow study requirements.Check my eligibility

What is being tested?

The study tests the combination of osimertinib with carotuximab in patients with EGFR-mutated NSCLC. It aims to determine the safest dose by monitoring adverse reactions, while also looking at how well tumors respond, how long they stop growing, survival without disease progression, and overall disease control.See study design

What are the potential side effects?

Potential side effects include those related to organ inflammation such as lung issues (but not pre-existing interstitial lung diseases), bleeding risks like ulcers or recent thrombolytics use, uncontrolled hypertension within a month before joining the trial, known allergies to certain antibodies or products from Chinese hamster ovary cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of the day.

Select...

My side effects from osimertinib are mild or gone.

Select...

My advanced lung cancer has a specific EGFR mutation.

Select...

My cancer has worsened despite treatment with an EGFR inhibitor.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed from baseline until eot, up to 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed from baseline until eot, up to 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from baseline until eot, up to 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

Biomarkers of response to the combination using tumor tissue and serial ctDNA.

Biomarkers using tumor tissue and serial ctDNA for mutations.

Disease control rate

+3 more

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551

10%

Blood creatine phosphokinase increased

10%

Fatigue

Decreased appetite

Diarrhoea

Cough

Mucosal inflammation

Rash

Pain in extremity

Constipation

Thrombocytopenia

Paronychia

Dyspnoea

Dengue fever

Disease progression

Cardio-respiratory arrest

Cataract

Mouth Ulceration

Deep Vein Thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Osimertinib with CarotuximabExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Karen Reckamp, MD, MSLead Sponsor

Enviro Therapeutics, Inc.UNKNOWN

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Carotuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05401110 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks have been associated with the use of Osimertinib?

"Osimertinib's safety was appraised with a score of 1 since it has not been thoroughly tested and there is only preliminary data that supports its efficacy."

Answered by AI

Are there any openings for participants in this clinical research?

"This clinical trial is not presently seeking participants according to the information found on clinicaltrials.gov; this study was initially posted on January 15th 2023 and last updated November 7th 2022. Despite that, there are still a total of 2179 other trials actively enrolling patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Karen Reckamp, MD, MS 2023. "Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05401110.