NCT05911308

Abequolixron (RGX-104) and Durvalumab in Lung Cancer

A Pilot Window of Opportunity Study Evaluating Durvalumab (MEDI4736) in Combination With Platinum Doublet Chemotherapy Followed by Evaluation of Durvalumab (MEDI4736) in Combination With Platinum Doublet Chemotherapy and Abequolixron (RGX-104) in Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	1,500 mg Durvalumab IV infusion will be given on day 1 of each cycle for 3 cycles.
DRUG	Carboplatin	Carboplatin IV infusion will be given on day 1 of each cycle for 3 cycles. The dose will be AUC 5.
DRUG	Abequolixron	100 or 120 mg Abequolixron will be administered by mouth twice a day for 5 days followed by 2 days off throughout your treatment (5 days a week for up to 9 weeks).
DRUG	Abraxane	100 mg/m2 Abraxane will be given by IV infusion on days 1, 8, and 15 of each cycle for 3 cycles.
DRUG	Pemetrexed	500 mg/m2 pemetrexed will be given by IV infusion on day 1 of each cycle for 3 cycles.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-10-04
• Completion: 2025-02-27
• First posted: 2023-06-22
• Last updated: 2025-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study