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Study of Osimertinib with Carotuximab for Advanced EGFR-Mutated Lung Cancer

This study is looking at a combination of two drugs, osimertinib and carotuximab, for people with advanced non-small cell lung cancer (NSCLC) that has a specific change in the EGFR gene (a type of mutation). Osimertinib is taken by mouth daily, and carotuximab is given through an IV (into a vein) weekly or every two weeks. The main goal is to find a safe dose for this drug combination and see how well people tolerate it. Researchers will also look at how effective the treatment is, including how many people respond to it and for how long. You may be able to join if you are 18 or older and have Stage IV or recurrent/metastatic non-squamous NSCLC with an EGFR activating mutation. The study plans to enroll 60 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 60 participants. The phase of the study is not specified.
What's involved
Participants will take osimertinib by mouth daily and receive carotuximab intravenously weekly or every two weeks. Treatment will continue until the disease progresses, the patient withdraws, or treatment is not tolerated.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for safety and dose-limiting toxicities is measured at 4 weeks.

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NCT05401110

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Karen Reckamp, MD, MS
~60 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:OsimertinibCarotuximab

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 4 weeks

Conditions

Non Small Cell Lung Cancer
Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

5 sites across 1 states
California5

Study leadership

  • Karen Reckamp, MD, MS · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Clinical Trial Recruitment Navigator
[email protected]
310-423-5842
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Stage IV or recurrent/metastatic non-squamous NSCLC that harbors an EGFR activating mutation (Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q, etc). Local testing for EGFR mutations is acceptable provided it was performed in a CLIA certified lab.
Part I: Progressive disease on at least one prior EGFR TKI
Part II, Cohort 1: Progressive disease on osimertinib or other prior EGFR TKIs
Part II, Cohort 2: Receiving osimertinib as front line treatment for less than 12 weeks. Persistent ctDNA with EGFR mutation between weeks 6-12 from the start of osimertinib treatment.
Age at least 18
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
Archival tissue from a biopsy performed after progression of disease on previous EGFR TKI or willing to consent for a fresh tumor biopsy.
Measurable disease by RECIST 1.1.
Patients with untreated brain metastases are allowed provided that the patient is clinically asymptomatic and stable.
Patients must have completed prior chemotherapy ≥ 3 weeks or radiotherapy ≥ 2 weeks prior to receiving study drugs.
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
If the subject's most recent line of therapy is any other treatment than osimertinib, then all Adverse Events must be resolved to grade 1 or better, with the exception of fatigue, alopecia and neuropathy (which must resolve to CTCAE grade 2).
Adequate organ function
Women of childbearing potential and men must agree to use adequate contraception while on study.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion

Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease.
Small cell lung cancer histology.
Other prior malignancy that might interfere with study endpoints per opinion of the investigator.
Prior exposure to carotuximab or any CD105 targeted antibody.
Any major surgical procedure within 2 weeks of starting therapy.
Patients must not have a history of uncontrolled or poorly-controlled hypertension defined as SBP \> 150 mmHg or DBP \> 90 mmHg within 28 days prior to enrollment.
Active bleeding or pathologic conditions that carries a high bleeding risk (e.g. gastric ulcers).
Use of thrombolytics within 10 days prior to the first day of carotuximab.
Known hypersensitivity to Chinese hamster ovary products or other recombinant human, chimeric, or humanized antibodies.
A known diagnosis of Osler-Weber-Rendu syndrome.
Ascites or pericardial or pleural effusion requiring external drainage procedures.
New evidence of leptomeningeal disease.
Acute cardiovascular event within the past 6 months.
Pregnancy or breastfeeding.

What this trial 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.4 weeks

    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.