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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
Must not have
Lack of full recovery from a major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't fully recovered from a major surgery within the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of surgery
Secondary study objectives
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 more

Trial 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
~6120
Durvalumab
2017
Completed Phase 2
~3840
Abraxane
2008
Completed Phase 2
~610
Pemetrexed
2014
Completed Phase 3
~5550

Find a Location

Who is running the clinical trial?

Rgenix, Inc.Industry Sponsor
2 Previous Clinical Trials
254 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
89,871 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,785 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05911308 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Neoadjuvant therapy
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05911308 — Phase 1
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05911308 — Phase 1
~16 spots leftby Dec 2025
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