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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

Must not have

Acute cardiovascular event within the past 6 months.

Prior exposure to carotuximab or any CD105 targeted antibody.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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

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

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My side effects from osimertinib are mild or gone.

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My advanced lung cancer has a specific EGFR mutation.

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My cancer has worsened despite treatment with an EGFR inhibitor.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a heart attack or other major heart problem in the last 6 months.

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I have never been treated with carotuximab or any CD105 targeted antibody.

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I have fluid buildup needing drainage.

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I have a condition that causes heavy bleeding or I am currently experiencing heavy bleeding.

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I have a history of lung conditions needing steroid treatment.

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I have been diagnosed with Osler-Weber-Rendu syndrome.

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My lung cancer is of the small cell type.

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I have not had major surgery in the last 2 weeks.

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My cancer has spread to the lining of my brain and spinal cord.

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My blood pressure has been under control, with SBP ≤ 150 mmHg and DBP ≤ 90 mmHg in the last 28 days.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Biomarkers using tumor tissue and serial ctDNA for mutations.

Disease control rate

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