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Chemotherapy
Combination Therapy for Lung Cancer
Phase 1
Recruiting
Led By Jared Weiss, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status of 0-1
Histologically or cytologically confirmed non-small cell lung cancer for which surgical resection would be standard of care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will investigate the effects of a combination of drugs (immunotherapy, platinum doublet chemotherapy, and abequolixron) to treat non-small cell lung cancer before surgery.
Who is the study for?
This trial is for adults over 18 with non-small cell lung cancer that can be surgically removed. They must weigh more than 40 kg, have a good performance status (able to carry out daily activities), and not be on other cancer treatments except those in the study.Check my eligibility
What is being tested?
The study tests how well non-small cell lung cancer responds before surgery to durvalumab (immunotherapy) plus chemotherapy (carboplatin with abraxane or pemetrexed), and when combined with an experimental drug called abequolixron.See study design
What are the potential side effects?
Possible side effects include immune-related reactions, fatigue, nausea from chemotherapy, potential liver issues due to abequolixron, and risks associated with new drug combinations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My lung cancer is confirmed and surgery is recommended.
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I can swallow and keep down pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of surgery
Secondary outcome measures
Clinical response rate (CRR) - durvalumab in combination with platinum doublet chemotherapy
Clinical response rate (CRR) - durvalumab in combination with platinum doublet chemotherapy plus abequolixron
Major pathologic response rate - non squamous histology
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant therapyExperimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Durvalumab
2017
Completed Phase 2
~3870
Abraxane
2008
Completed Phase 2
~610
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
Rgenix, Inc.Industry Sponsor
2 Previous Clinical Trials
210 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,309 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,272 Previous Clinical Trials
288,612,651 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My lung cancer is confirmed and surgery is recommended.I am not on any cancer treatments except those allowed in this study or hormone therapy for non-cancer reasons.You have had an organ transplant from another person.You weigh more than 40 kilograms.I can swallow and keep down pills.I am 18 years old or older.I haven't fully recovered from a major surgery within the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this study open at present?
"According to what's available on clinicaltrials.gov, this particular medical trial is no longer enrolling patients. Despite having been initially posted on November 30th 2023 and last edited on June 9th 2023, the study now stands as inactive when compared with the 2,075 other studies actively recruiting individuals at present."
Answered by AI
Has Neoadjuvant therapy attained authorization from the FDA?
"Neoadjuvant therapy is considered relatively safe, therefore it was given a score of 1. This assessment is based on the fact that this is Phase 1 trial and thus there exists limited evidence to support its safety and efficacy."
Answered by AI
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