Recruiting
Phase 1

Osimertinib & Carotuximab

Sponsor:

Karen Reckamp, MD, MS

Code:

NCT05401110

Conditions

Non Small Cell Lung Cancer

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Osimertinib

Carotuximab

Study Details

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 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

Non Small Cell Lung Cancer

Lung Cancer

Study ID

NCT05401110

Start date

Sep 15, 2023

Status verified date

Aug, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Osimertinib with Carotuximab

Interventions

Osimertinib

Osimertinib given by mouth daily at 40mg or 80mg depending on the starting dose level assigned per investigator. Therapy will continue until disease progression, patient withdrawal, or treatment intolerance.

Carotuximab

Carotuximab is administered intravenously weekly for the first 4 weeks, then every 2 weeks at 10mg/kg or 15 mg/kg depending on the starting dose level assigned per investigator. Therapy will continue until disease progression, patient withdrawal, or treatment intolerance.

Primary outcome measure

  • 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. [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Locations

Cedars-Sinai Cancer at Beverly Hills (THO)

Recruiting

Beverly Hills, California, United States, 90211

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute

Recruiting

Los Angeles, California, United States, 90025

Cedars-Sinai Cancer at SOCC

Recruiting

Los Angeles, California, United States, 90048

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Cedars-Sinai Cancer at Hunt Cancer Center - TMPNCC

Recruiting

Torrance, California, United States, 90505

More Information

Sponsor

Karen Reckamp, MD, MS

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • EGFR
  • Osimertinib
  • Carotuximab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Karen Reckamp, MD, MS on 2026-08-06.