10 Participants Needed

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

SN
CC
Overseen ByChristian Chukwuma
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Single arm, Phase II trial of concurrent Durvalumab (MEDI 4736) and radiotherapy followed by consolidative Durvalumb (MEDI 4736) for Stage III Non-Small Cell Lung Cancer (NSCLC)

Who Is on the Research Team?

YZ

Yuanyuan Zhang, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My N2 disease was confirmed by a biopsy or a PET/CT scan.
My cancer is at a stage where surgery isn't an option due to large lymph nodes in my chest.
I had lung infection due to blockage but don't need IV antibiotics anymore.
See 12 more

Exclusion Criteria

You have a serious health problem, a history of certain medical conditions, a recent surgery, or are not using contraception during the study.
Receiving any other investigational agents for the treatment of the cancer under study
I've had radiation in the same area as my current cancer.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Concurrent Treatment

Participants receive 1500mg intravenous durvalumab once every 4 weeks while receiving a 60 Gy/30 Fraction course of thoracic radiotherapy

6 weeks
6 visits (in-person)

Consolidative Treatment

Participants continue to receive 1500mg intravenous durvalumab once every 4 weeks for up to one year following the start of treatment

12 months
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

What Are the Treatments Tested in This Trial?

Interventions

  • Durvalumab
  • Thoracic RT
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single Arm: Therapeutic InterventionExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security