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PD-L1 Inhibitor

Quick Start Durvalumab for Lung Cancer

Phase 2

Recruiting

Led By Thomas Lycan, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0-2.

Eighteen years old or greater.

Must not have

Uncontrolled intercurrent illness includes ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone >20 mg/day for more than one week).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine how Durvalumab impacts cancer patients and if a quick start helps. Logistic barriers to quick start will also be studied.

Who is the study for?

This trial is for adults with Stage III non-small cell lung cancer who've recently completed or are completing chemoradiation. They must have a life expectancy over three months, be able to use contraception if necessary, and sign informed consent. Excluded are those with uncontrolled symptoms, cancer progression during radiation, active autoimmune diseases requiring steroids, pregnancy/breastfeeding, certain heart conditions or mental illnesses affecting study compliance.

What is being tested?

The trial tests the effects of Durvalumab given within 14 days after finishing chemotherapy and radiation ('quick start'). It examines both positive and negative outcomes on patients' health and identifies logistical challenges in starting treatment promptly.

What are the potential side effects?

Durvalumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), potential infusion reactions like fever or chills, fatigue from treatment burden, possible impact on breathing function measured by dyspnea scales.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of the day.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have had severe lung inflammation treated with high-dose steroids.

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I have severe breathing problems that affect my daily activities.

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My lung cancer got worse during radiation treatment.

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I am taking medication to suppress my immune system due to an autoimmune disease.

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I have been treated with drugs that target the immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days)

Secondary study objectives

Number of Barriers to Initiation of Durvalumab - Early (Days 8-14)

Number of Barriers to Initiation of Durvalumab - Very Early (Days 1-7)

Number of Participants Who Have All-Cause Any Grade Pneumonitis - Early Fidelity (1-14 days)

+7 more

Other study objectives

Change in Patient-Reported Outcomes Scores (PROs) - European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Version 3

Change in Patient-Reported Outcomes Scores (PROs) - Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Questionnaire

Change in Respiratory Patient Reported Outcomes (PROs) - COPD Assessment Test (CAT)

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