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NCT05401110 · ClinicalTrials.gov registry record · Phase 1
Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer
A Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by Karen Reckamp, MD, MS.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 5
- Study locations
NCT05401110 is a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer that is actively recruiting participants, run by Karen Reckamp, MD, MS. The registered enrollment target is 60 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower). The trial reports 5 study locations across 1 state.
The verdict
NCT05401110, a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, is actively recruiting participants, sponsored by Karen Reckamp, MD, MS.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 5
- Study locations
Study 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 Studied
Interventions
- DRUG Osimertinib
- DRUG Carotuximab
Study Locations (5)
California
- Cedars-Sinai Cancer at Beverly Hills (THO) - Beverly Hills
- Cedars-Sinai Cancer at The Angeles Clinic and Research Institute - Los Angeles
- Cedars-Sinai Cancer at SOCC - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Cedars-Sinai Cancer at Hunt Cancer Center - TMPNCC - Torrance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-09-15 |
| Est. Completion | 2029-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05401110
The ClinicalTrials.gov registry entry for NCT05401110 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Karen Reckamp, MD, MS, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Osimertinib is the first listed.
NCT05401110 reports 5 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05401110 about?
NCT05401110 is a clinical study titled "Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer". 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, acc...
What is the current status of trial NCT05401110?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-09-15. Estimated completion is 2029-01.
What conditions does trial NCT05401110 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Lung Cancer.
What interventions are being tested in trial NCT05401110?
The interventions under investigation include: Osimertinib (DRUG), Carotuximab (DRUG).
Who is sponsoring clinical trial NCT05401110?
This trial is sponsored by Karen Reckamp, MD, MS, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05401110 being conducted?
This trial has 5 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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