Status:
RECRUITING
Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
Lead Sponsor:
Karen Reckamp, MD, MS
Collaborating Sponsors:
Enviro Therapeutics, Inc.
Conditions:
Non Small Cell Lung Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 can...
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.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05401110
Start Date
September 15 2023
End Date
January 1 2028
Last Update
September 10 2025
Active Locations (5)
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1
Cedars-Sinai Cancer at Beverly Hills (THO)
Beverly Hills, California, United States, 90211
2
Cedars-Sinai Cancer at The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
3
Cedars-Sinai Cancer at SOCC
Los Angeles, California, United States, 90048
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048