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Durvalumab + Radiotherapy for Stage III Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By David Gerber, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically proven diagnosis of NSCLC with medically inoperable stage IIIA or stage IIIB disease
Inoperable Stage IIIA disease defined by multiple and/or bulky N2 mediastinal lymph nodes on CT scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving both radiation and a new drug, Durvalumab. The goal is to see if this treatment is effective for Stage III Non-Small Cell Lung Cancer.

Who is the study for?
Adults over 18 with stage IIIA or IIIB non-small cell lung cancer (NSCLC) that can't be operated on. They must have a life expectancy of at least 12 weeks, good organ function, and no severe illnesses or allergies to trial drugs. Women must not be pregnant and participants agree to use contraception.Check my eligibility
What is being tested?
This Phase II trial tests Durvalumab with thoracic radiotherapy followed by additional Durvalumab for NSCLC. It's a single-arm study where all eligible patients receive the same treatment without comparison groups.See study design
What are the potential side effects?
Durvalumab may cause immune-related inflammation in various organs, infusion reactions similar to allergic responses, increased risk of infections due to weakened immunity, and potential harm to an unborn baby.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is at stage IIIA or IIIB and cannot be removed with surgery.
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My cancer is at a stage where surgery isn't an option due to large lymph nodes in my chest.
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My N2 disease was confirmed by a biopsy or a PET/CT scan.
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My lung cancer can be surgically removed, as decided by my surgeon.
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My cancer stage fits the study requirements based on recent scans and exams.
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I am 18 years old or older.
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I can carry out all my normal activities without help.
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My breathing function is normal.
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I had lung infection due to blockage but don't need IV antibiotics anymore.
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My pleural effusion is non-cancerous and can be treated with radiotherapy.
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I have had limited previous treatments.
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My organs and bone marrow are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Distant metastases free survival
Local and regional control
Overall survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm: Therapeutic InterventionExperimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,039 Previous Clinical Trials
1,048,049 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,238 Previous Clinical Trials
288,471,371 Total Patients Enrolled
David Gerber, MDPrincipal InvestigatorUT Southwestern Medical Center
5 Previous Clinical Trials
157 Total Patients Enrolled

Media Library

Thoracic RT Clinical Trial Eligibility Overview. Trial Name: NCT04003246 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Single Arm: Therapeutic Intervention
Non-Small Cell Lung Cancer Clinical Trial 2023: Thoracic RT Highlights & Side Effects. Trial Name: NCT04003246 — Phase 2
Thoracic RT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04003246 — Phase 2

Frequently Asked Questions

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

Is enrollment open for this investigation?

"According to clinicaltrials.gov, this particular medical study is not actively recruiting patients right now. The trial was initially posted on April 3rd 2020 and the last update came through August 16th 2022. However, there are over two thousand three hundred other trials that may be of interest for individuals looking to participate in a medical trial at present."

Answered by AI

What conditions are typically treated with Thoracic RT and Durvalumab?

"Thoracic RT and Durvalumab is a treatment regimen applied to unresectable stage 3 non-small cell lung cancer. Additionally, it can be used on patients with metastatic ureter urothelial carcinoma or in advance directives."

Answered by AI

To what degree is Thoracic RT and Durvalumab hazardous to the health of participants?

"As is befitting a Phase 2 trial, Thoracic RT and Durvalumab were assessed to have safety levels of 2 on our scale. There is evidence that backs up their security but no data confirming efficacy."

Answered by AI

How many participants have signed up for the research study?

"Unfortunately, no additional participants are being sought for this trial which was first opened on April 3rd 2020 and last updated August 16th 2022. On the other hand, there are presently 2045 trials recruiting patients with malignant neoplasms and 333 clinical studies looking for volunteers to receive Thoracic Radiation Therapy in combination with Durvalumab medication."

Answered by AI

What prior research has been done involving Thoracic RT and Durvalumab?

"Currently, 333 active clinical trials researching Thoracic RT and Durvalumab are occurring worldwide. Of these investigations, 52 have reached the pivotal Phase 3 stage of testing. Although a large portion of research is based in Cordoba, Texas; an expansive network of medical sites across 12949 locations offer this therapy to participants."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
What portion of applicants met pre-screening criteria?
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas: < 48 hours
~13 spots leftby Aug 2025