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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3750