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 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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 21, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Interventions being studied
- Drug: Durvalumab; Drug: Carboplatin; Drug: Abequolixron; Drug: Abraxane; Drug: Pemetrexed
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
1. Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information. 2. Age ≥ 18 years at the time of consent. 3. Histologically or cytologically confirmed non-small cell lung cancer for which surgical resection would be standard of care. 4. ECOG Performance Status of 0-1 5. Body weight of \> 40 kg 6. Is able to swallow and retain oral medication.
1. Participation in another clinical study with an investigational product during the last 3 weeks 2. Concurrent enrollment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. 3. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment with the exception of those mentioned in this protocol. Concurrent use of hormonal therapy for noncancer- related conditions (e.g., hormone replacement therapy) is acceptable. 4. Lack of full recovery from a major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. 5. History of allogenic organ transplantation.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UNC Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 21, 2025. Always confirm current availability with the study team.