Abequolixron (RGX-104) and Durvalumab in Lung Cancer

NCT ID: NCT05911308

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-02-27

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant therapy

Subjects with operable Non-Small Cell Lung Cancer received neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (RGX-104), an LXR/ApoE agonist.

Group Type: EXPERIMENTAL

Durvalumab

Intervention Type: DRUG

1,500 mg Durvalumab IV infusion will be given on day 1 of each cycle for 3 cycles.

Carboplatin

Intervention Type: DRUG

Carboplatin IV infusion will be given on day 1 of each cycle for 3 cycles. The dose will be AUC 5.

Abequolixron

Intervention Type: DRUG

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).

Abraxane

Intervention Type: DRUG

100 mg/m2 Abraxane will be given by IV infusion on days 1, 8, and 15 of each cycle for 3 cycles.

Pemetrexed

Intervention Type: DRUG

500 mg/m2 pemetrexed will be given by IV infusion on day 1 of each cycle for 3 cycles.

Interventions

Durvalumab

1,500 mg Durvalumab IV infusion will be given on day 1 of each cycle for 3 cycles.

Intervention Type: DRUG

Carboplatin

Carboplatin IV infusion will be given on day 1 of each cycle for 3 cycles. The dose will be AUC 5.

Intervention Type: 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).

Intervention Type: DRUG

Abraxane

100 mg/m2 Abraxane will be given by IV infusion on days 1, 8, and 15 of each cycle for 3 cycles.

Intervention Type: DRUG

Pemetrexed

500 mg/m2 pemetrexed will be given by IV infusion on day 1 of each cycle for 3 cycles.

Intervention Type: DRUG

Other Intervention Names

Imfinzi; Paraplatin; RGX 104; RGX-104; RGX104; SB-742881; Paclitaxel albumin-bound; Nab-paclitaxel; Alimta

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Rgenix, Inc.

INDUSTRY

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jared Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

Clinical trials at UNC Lineberger

Other Identifiers

LCCC2113

Identifier Type: -

Identifier Source: org_study_id