Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Karen Reckamp, MD, MS
Study ID
NCT05401110
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 15, 2023
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib with Carotuximab

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

Locations (5)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Cancer at Beverly Hills (THO)Beverly HillsCalifornia90211
Clinical Trial Recruitment Navigator
Cedars-Sinai Cancer at SOCCLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
Cedars-Sinai Cancer at The Angeles Clinic and Research InstituteLos AngelesCalifornia90025
Clinical Trial Recruitment Navigator
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
310-423-2133
Cedars-Sinai Cancer at Hunt Cancer Center - TMPNCCTorranceCalifornia90505
Clinical Trial Recruitment Navigator

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Cedars-Sinai Cancer at Beverly Hills (THO)· Beverly Hills, CACedars-Sinai Cancer at SOCC· Los Angeles, CACedars-Sinai Cancer at The Angeles Clinic and Research Institute· Los Angeles, CACedars-Sinai Medical Center· Los Angeles, CACedars-Sinai Cancer at Hunt Cancer Center - TMPNCC· Torrance, CA

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