Experimental combo aims to outsmart resistant lung cancer
NCT ID NCT05401110
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This early-phase trial tests whether adding carotuximab to the standard drug osimertinib is safe for people with advanced EGFR-mutated non-small cell lung cancer. About 60 participants whose cancer has progressed on prior treatments will receive both drugs. The main goal is to find the best dose and check for side effects, while also seeing if the combination can shrink tumors or delay progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Osimertinib and carotuximab
- What this could lead to
- If this works, it could offer a new treatment option for people with EGFR-mutated lung cancer whose current therapy stops working.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety, not yet proven to work. The combination may cause side effects or not shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Cancer at Beverly Hills (THO)
RECRUITINGBeverly Hills, California, 90211, United States
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Cedars-Sinai Cancer at Hunt Cancer Center - TMPNCC
RECRUITINGTorrance, California, 90505, United States
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Cedars-Sinai Cancer at SOCC
RECRUITINGLos Angeles, California, 90048, United States
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Cedars-Sinai Cancer at The Angeles Clinic and Research Institute
RECRUITINGLos Angeles, California, 90025, United States
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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