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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
Must not have
Definitive clinical or radiologic evidence of metastatic disease
Current invasive malignancy except non-melanomatous skin cancer, localized bladder and prostate cancer, and permissible carcinoma in situ
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

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.
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.
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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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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I had lung infection due to blockage but don't need IV antibiotics anymore.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to other parts of my body.
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I have cancer, but it's not skin, localized bladder, prostate cancer, or certain in situ cancers.
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I've had radiation in the same area as my current cancer.
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I have received specific treatments for non-small cell lung cancer.
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I haven't taken steroids or immunosuppressants in the last 7 days.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
1,080 Previous Clinical Trials
1,056,258 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,397 Previous Clinical Trials
289,121,607 Total Patients Enrolled
David Gerber, MDPrincipal InvestigatorUT Southwestern Medical Center
5 Previous Clinical Trials
141 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
~6 spots leftby Aug 2025
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