← Back to Search

ctDNA Testing + Durvalumab for Stage 3 Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Nasser Hanna, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 months

Awards & highlights

Study Summary

This trial wants to use genetic testing to better tailor cancer treatment for stage 3 lung cancer patients.

Who is the study for?

This trial is for adults over 18 with stage III NSCLC who can't have surgery and are set to receive or already started concurrent chemo-radiotherapy (CRT) followed by Durvalumab. They must be able to consent and provide tissue samples for ctDNA testing. Those with other active cancers or unable to undergo CRT/Durvalumab treatment cannot participate.Check my eligibility

What is being tested?

The study tests if monitoring tumor DNA in the blood can guide the duration of Durvalumab therapy in patients with stage III NSCLC after initial treatment with CRT. It aims to personalize cancer care based on molecular markers rather than just clinical signs.See study design

What are the potential side effects?

Durvalumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems, infusion-related reactions, fatigue, and increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine if de-escalating number of Durvalumab cycles based on personalized ctDNA clearance has non-inferior 2-year PFS rate

Secondary outcome measures

Estimate the 24-month PFS in patients with persistently detectable ctDNA without radiographic progression

Estimate the 24-month overall survival (OS) of patient treated with consolidation Durvalumab based on personalized ctDNA clearance

Trial Design

1Treatment groups

Experimental Treatment

Group I: Consolidation to DurvalumabExperimental Treatment2 Interventions

All subjects will receive consolidation Durvalumab approximately every 4 weeks. Prior to the 5th cycle the first mandatory ctDNA test will be done. If it's negative and the subsequent test 4 weeks later prior to cycle 6 is negative, then Durvalumab will be stopped otherwise subject will continue consolidation durvalumab until 2 negative ctDNA analyses performed approximately 4 weeks apart or up to 1 year of consolidation per standard medical practice is complete.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,706 Total Patients Enrolled

Nasser Hanna, MDPrincipal InvestigatorIndiana University

6 Previous Clinical Trials

367 Total Patients Enrolled

Media Library

Consolidation to Durvalumab Clinical Trial Eligibility Overview. Trial Name: NCT05757843 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Consolidation to Durvalumab

Non-Small Cell Lung Cancer Clinical Trial 2023: Consolidation to Durvalumab Highlights & Side Effects. Trial Name: NCT05757843 — Phase 2

Consolidation to Durvalumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05757843 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned a switch to Durvalumab for Consolidation?

"As Consolidation to Durvalumab is currently undergoing Phase 2 trials, the safety of this medication has been rated a 2 on our scale due to existing data that supports its security but lacks evidence for efficacy."

Answered by AI

Is this experiment still enlisting participants?

"The data preserved on clinicaltrials.gov demonstrates that this trial, which was first posted on March 1st 2023 and last updated February 24th 2023, is not presently recruiting participants. In lieu of registering for this specific study, there are 41 other studies seeking enrolment at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Using Circulating Tumor DNA to Personalize Duration of Consolidation Durvalumab

Nasser Hanna 2024. "Using Circulating Tumor DNA to Personalize Duration of Consolidation Durvalumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05757843.