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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: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by Karen Reckamp, MD, MS.
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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of adverse events are graded by NCI CTCAE v5.0. The number of these dose-limiting toxicities (DLTs) experienced within the first treatment cycle (28 days) will be assessed to determine the RP2D.
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 |
What NCT05401110 shows while recruiting
NCT05401110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower).
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 lists 5 locations in 1 state (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05401110's enrollment target sits among peer trials
60 313th of 454 higher than 135 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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