drugset / Trial / NCT05911308

Abequolixron (RGX-104) and Durvalumab in Lung Cancer

NCT05911308

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-04-01
Primary completion
2024-10-04
Completion
2025-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Abequolixron Small molecule 100 mg Oral
Subject Abequolixron Small molecule 120 mg Oral
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous