Trial Title:
Abequolixron (RGX-104) and Durvalumab in Lung Cancer
NCT ID:
NCT05911308
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pemetrexed
Durvalumab
Conditions: Keywords:
Neoadjuvant therapy
abequolixron (RGX-104)
LXR/ApoE
carboplatin
abraxane
pemetrexed
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
1,500 mg Durvalumab IV infusion will be given on day 1 of each cycle for 3 cycles.
Arm group label:
Neoadjuvant therapy
Other name:
Imfinzi
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin IV infusion will be given on day 1 of each cycle for 3 cycles. The dose will
be AUC 5.
Arm group label:
Neoadjuvant therapy
Other name:
Paraplatin
Intervention type:
Drug
Intervention name:
Abequolixron
Description:
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).
Arm group label:
Neoadjuvant therapy
Other name:
RGX 104
Other name:
RGX-104
Other name:
RGX104
Other name:
SB-742881
Intervention type:
Drug
Intervention name:
Abraxane
Description:
100 mg/m2 Abraxane will be given by IV infusion on days 1, 8, and 15 of each cycle for 3
cycles.
Arm group label:
Neoadjuvant therapy
Other name:
Paclitaxel albumin-bound
Other name:
Nab-paclitaxel
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
500 mg/m2 pemetrexed will be given by IV infusion on day 1 of each cycle for 3 cycles.
Arm group label:
Neoadjuvant therapy
Other name:
Alimta
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Tara Ackerman
Email:
tara.ackerman@moffitt.org
Investigator:
Last name:
Alberto Chiaporri, MD
Email:
Principal Investigator
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27516
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Higgins
Email:
lqhiggin@ad.unc.edu
Investigator:
Last name:
Jared Weiss, MD
Email:
Principal Investigator
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Michael Oldfield
Email:
Michael.Oldfield@fccc.edu
Investigator:
Last name:
Hossein Borghaei, MS, DO
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
December 19, 2026
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
Rgenix, Inc.
Agency class:
Industry
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05911308
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
