Actively Recruiting
Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
Led by Karen Reckamp, MD, MS · Updated on 2026-05-07
60
Participants Needed
5
Research Sites
276 weeks
Total Duration
On this page
Sponsors
K
Karen Reckamp, MD, MS
Lead Sponsor
E
Enviro Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to examine the combination of osimertinib and carotuximab to assess the safety and find the recommended dose for treatment of advanced EGFR-mutated non-small cell lung cancer (NSCLC). Safety and tolerability will be measured by the number of dose-limiting toxicities, according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5, to find the maximum tolerated dose. The secondary objectives include evaluating the rate of objective response rate, duration of response, progression-free survival, and disease control rate, along with assessing biomarkers through tumor tissue and circulating tumor DNA.
CONDITIONS
Official Title
Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stage IV or recurrent/metastatic non-squamous NSCLC with an EGFR activating mutation
- Progressive disease on at least one prior EGFR TKI for Part I
- Progressive disease on osimertinib or other EGFR TKIs for Part II, Cohort 1
- Receiving osimertinib as front line treatment for less than 12 weeks with persistent EGFR mutation ctDNA for Part II, Cohort 2
- Age 18 years or older
- ECOG Performance Status 0-2
- Archival or fresh tumor biopsy available after progression on prior EGFR TKI
- Measurable disease by RECIST 1.1
- Clinically asymptomatic and stable untreated brain metastases allowed
- Completed prior chemotherapy at least 3 weeks or radiotherapy at least 2 weeks before study drugs
- Adverse events resolved to Grade 2 or better if most recent therapy was osimertinib
- Adverse events resolved to Grade 1 or better (except fatigue, alopecia, neuropathy to Grade 2) if other therapy
- Adequate organ function
- Women of childbearing potential and men must use contraception
- Able to provide informed consent and comply with study requirements
You will not qualify if you...
- History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroids
- Small cell lung cancer histology
- Other prior malignancies that might interfere with the study
- Previous exposure to carotuximab or CD105 targeted antibodies
- Major surgery within 2 weeks before starting therapy
- Uncontrolled or poorly controlled hypertension (SBP >150 mmHg or DBP >90 mmHg within 28 days prior)
- Active bleeding or high bleeding risk conditions
- Use of thrombolytics within 10 days before carotuximab
- Known allergy to Chinese hamster ovary products or similar antibodies
- Diagnosis of Osler-Weber-Rendu syndrome
- Ascites or pericardial or pleural effusion needing drainage
- New evidence of leptomeningeal disease
- Acute cardiovascular event within past 6 months
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Cedars-Sinai Cancer at Beverly Hills (THO)
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Cedars-Sinai Cancer at The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Actively Recruiting
3
Cedars-Sinai Cancer at SOCC
Los Angeles, California, United States, 90048
Actively Recruiting
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
Cedars-Sinai Cancer at Hunt Cancer Center - TMPNCC
Torrance, California, United States, 90505
Actively Recruiting
Research Team
C
Clinical Trial Recruitment Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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