Clinical trial NCT05911308: Abequolixron (RGX-104) and Durvalumab in Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Keywords: Neoadjuvant therapy
abequolixron (RGX-104)
LXR/ApoE
carboplatin
abraxane
pemetrexed
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Rgenix, Inc.
First posted: 2023-06-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Feasibility of surgery
timeFrame: Up to 120 days
Secondary outcomes:
measure: Toxicities
timeFrame: Up to 1 years after surgery
measure: Major pathologic response rate - squamous histology
timeFrame: Up to 120 days
measure: Major pathologic response rate - non squamous histology
timeFrame: Up to 120 days
measure: Pathologic complete response rate (PCR) -durvalumab in combination with platinum doublet chemotherapy
timeFrame: Up to 120 days
measure: Pathologic complete response rate (PCR) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron
timeFrame: Up to 120 days
measure: Clinical response rate (CRR) - durvalumab in combination with platinum doublet chemotherapy
timeFrame: Up to 1 years after surgery
measure: Clinical response rate (CRR) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron
timeFrame: Up to 1 years after surgery
measure: Recurrence-free survival (RFS) - durvalumab in combination with platinum doublet chemotherapy
timeFrame: Up to 5 years
measure: Recurrence-free survival (RFS)- durvalumab in combination with platinum doublet chemotherapy plus abequolixron
timeFrame: Up to 5 years
measure: Overall Survival (OS) - durvalumab
timeFrame: Up to 5 years
measure: Overall Survival (OS) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Jared Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: