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NCT05911308 · ClinicalTrials.gov registry record · Phase 1
Abequolixron (RGX-104) and Durvalumab in Lung Cancer
A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT05911308: Clinical Trial Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT05911308 is a Phase 1 study that was terminated before completion, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05911308, a Phase 1 study, was terminated before completion, sponsored by UNC Lineberger Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Non-Small Cell Lung Cancer (NSCLC) is one of the deadliest types of cancer. In lung cancer patients with a tumor that can be removed by surgery, adjuvant chemotherapy increases survival. Neoadjuvant therapy may have advantages such as, it may be more tolerable prior to surgery, earlier treatment may be more efficacious, and it can provide an indication of treatment response. Neoadjuvant treatment can provide pre- and post-treatment specimens for correlative analysis to better understand mechanisms of action and resistance. This pilot study will investigate the effects of neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist, in subjects with NSCLC who are scheduled to undergo surgical resection as part of their standard of care. The purpose of this study is to study how well using a combination of durvalumab, platinum doublet chemotherapy (carboplatin/abraxane or carboplatin/pemetrexed), and abequolixron treats non-small cell lung cancer before surgery. Durvalumab (a type of immunotherapy) and platinum doublet chemotherapy are drugs that are individually approved for use during the treatment of cancer. FDA (Food and Drug Administration) has not approved the combined use of these drugs in treating non-small cell lung cancer. Abequolixron is not FDA approved for the treatment of cancer.
Primary Outcome
Feasibility will be evaluated as the delay time between the completion of neoadjuvant therapy and surgery. A failure of feasibility will be defined as a delay in the planned surgery of more than 42 days (surgical delay of 35 days, plus 7 days for scheduling).
Interventions
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Durvalumab
- DRUG Abraxane
- DRUG Abequolixron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2025-02-27 |
| Phase | Phase 1 |
Why NCT05911308 stopped before completion
NCT05911308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT05911308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05911308 about?
NCT05911308 is a clinical study titled "Abequolixron (RGX-104) and Durvalumab in Lung Cancer". Non-Small Cell Lung Cancer (NSCLC) is one of the deadliest types of cancer. In lung cancer patients with a tumor that can be removed by surgery, adjuvant chemotherapy increases survival. Neoadjuvant therapy may have advantages such as, it may be more tolerable prior to surgery, earlier treatment may...
What is the current status of trial NCT05911308?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2024-04-01. Estimated completion is 2025-02-27.
What interventions are being tested in trial NCT05911308?
The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Durvalumab (DRUG), Abraxane (DRUG), Abequolixron (DRUG).
Who is sponsoring clinical trial NCT05911308?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05911308's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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