Abequolixron (RGX-104) and Durvalumab in Lung Cancer

NCT05911308 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: LCCC2113
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

Neoadjuvant therapy; abequolixron (RGX-104); LXR/ApoE; carboplatin; abraxane; pemetrexed

Outcome Measures

Primary Outcomes (1)

• Feasibility of surgery

  Feasibility will be evaluated as the delay time between the completion of neoadjuvant therapy and surgery. A failure of feasibility will be defined as a delay in the planned surgery of more than 42 days (surgical delay of 35 days, plus 7 days for scheduling).

  Up to 120 days

Secondary Outcomes (11)

• Toxicities

  Up to 1 years after surgery

• Major pathologic response rate - squamous histology

  Up to 120 days

• Major pathologic response rate - non squamous histology

  Up to 120 days

• Pathologic complete response rate (PCR) -durvalumab in combination with platinum doublet chemotherapy

  Up to 120 days

• Pathologic complete response rate (PCR) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron

  Up to 120 days

Study Arms (1)

Neoadjuvant therapy

EXPERIMENTAL

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.

Drug: Durvalumab; Drug: Carboplatin; Drug: Abequolixron; Drug: Abraxane; Drug: Pemetrexed

Interventions

Durvalumab DRUG

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

Also known as: Imfinzi

Neoadjuvant therapy

Carboplatin DRUG

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

Also known as: Paraplatin

Neoadjuvant therapy

Abequolixron 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).

Also known as: RGX 104, RGX-104, RGX104, SB-742881

Neoadjuvant therapy

Abraxane DRUG

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

Also known as: Paclitaxel albumin-bound, Nab-paclitaxel

Neoadjuvant therapy

Pemetrexed DRUG

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

Also known as: Alimta

Neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent obtained to participate in the study and
• HIPAA authorization for the release of personal health information.
• Age ≥ 18 years at the time of consent.
• Histologically or cytologically confirmed non-small cell lung cancer for which surgical resection
• would be standard of care.
• ECOG Performance Status of 0-1
• Body weight of \> 40 kg
• Is able to swallow and retain oral medication.

You may not qualify if:

• Participation in another clinical study with an investigational product during the last 3 weeks
• 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.
• 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.
• Lack of full recovery from a major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
• History of allogenic organ transplantation.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• AstraZeneca: collaborator
• Rgenix, Inc.: collaborator

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27516, United States

Location

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab; Carboplatin; SB 742881; Albumin-Bound Paclitaxel; Taxes; 130-nm albumin-bound paclitaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Officials

• Jared Weiss, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 22, 2023
• Study Start: April 1, 2024
• Primary Completion: October 4, 2024
• Study Completion: February 27, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)