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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take care of myself and am up and about more than half of the day.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants to Achieve Fidelity to Early Treatment with Durvalumab - Early Initiation (1-14 days)
Secondary outcome measures
Incidences of All Adverse Events
Number of Barriers to Initiation of Durvalumab - Early (Days 8-14)
Number of Barriers to Initiation of Durvalumab - Very Early (Days 1-7)
+7 moreOther outcome measures
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)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Quick Start DurvalumabExperimental Treatment4 Interventions
Standard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,702 Total Patients Enrolled
Thomas Lycan, MDPrincipal InvestigatorWake Forest Baptist Comprehensive Cancer Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of the day.My condition cannot be treated with surgery.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have had severe lung inflammation treated with high-dose steroids.I am 18 years old or older.I am undergoing or scheduled for specific radiation therapy for lung cancer, or I completed it recently.I can understand and am willing to sign the consent form myself or through a legal representative.I am about to start, currently on, or just finished platinum-based chemotherapy for lung cancer.I have severe breathing problems that affect my daily activities.My lung cancer got worse during radiation treatment.I am scheduled for Durvalumab treatment after chemotherapy and radiation for lung cancer.I am taking medication to suppress my immune system due to an autoimmune disease.You are expected to live for at least three more months.I have been treated with drugs that target the immune system.My lung cancer is confirmed as Stage III.My lung cancer has a mutation sensitive to specific targeted therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Quick Start Durvalumab
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.
What potential adverse effects might be associated with the utilization of Quick Start Durvalumab?
"Based on the available safety data, Quick Start Durvalumab was assigned a score of 2 as it is currently undergoing Phase 2 trials and lacks efficacy-supporting evidence."
Answered by AI
Are enrollment slots still available for participation in this research program?
"Per the data on clinicaltrials.gov, no new patients are being accepted into this trial at present. The initial posting was made on March 1st 2023 and the most recent update took place December 1st 2023. That said, there is an abundance of other medical research projects seeking candidates right now with a total of 1869 trials actively enrolling participants."
Answered by AI
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