NCT05401110
Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
Recruiting · Phase 1 · Karen Reckamp, MD, MS · registry updated 2026-08-06
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
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
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.