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PD-L1 Inhibitor

Immunotherapy + Radiation for Lung Cancer

Phase 2

Recruiting

Led By Dat Vo, 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

Body weight greater than 30 kg

Eastern Cooperative Oncology Group Performance status 0 to 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post-treatment

Awards & highlights

Study Summary

This trial is testing a new lung cancer treatment that combines a immunotherapy drug with radiation. The radiation is given on a different schedule than usual, either every other day or every four weeks. The trial will last for two years and follow patients closely to see how well the treatment works.

Who is the study for?

Adults over 18 with advanced non-small cell lung cancer, who haven't had prior radiation or surgery in the treatment area and have at least one symptomatic metastatic site. They must be able to consent, follow study protocol, have a life expectancy over six months, and use effective birth control. Exclusions include certain medication uses, unresolved toxicities from past therapies, major surgeries within the last month, organ transplants, pregnancy or nursing.Check my eligibility

What is being tested?

The trial is testing Durvalumab combined with stereotactic radiotherapy on patients with advanced NSCLC. It aims to see how this affects their quality of life and cancer outcomes. Patients are randomly assigned to receive radiotherapy either every other day (SAbR) or every four weeks (PULSAR), alongside Durvalumab for two years.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions due to Durvalumab affecting organs like lungs or intestines; fatigue; infusion reactions during drug administration; bone marrow suppression leading to blood disorders; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My body weight is over 30 kg.

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I can take care of myself and perform daily activities.

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I have had surgery to stabilize bones in my legs or spine due to cancer spread.

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I have not had radiation or surgery on the cancer area to be treated.

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I am 18 years old or older.

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I have biopsy-proven metastatic non-small cell lung cancer and can receive immunotherapy.

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I have 1 to 10 sites in my body where cancer has spread and is causing symptoms or getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Quality of Life Scores

Secondary outcome measures

Instances of Toxicity

Local control (LC)

Out-of-field control

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) plus Durvalumab armExperimental Treatment2 Interventions

PULSAR with each radiation treatment fraction delivered every 4 weeks

Group II: Stereotactic Ablative Radiotherapy (SAbR) Arm plus Durvalumab armActive Control2 Interventions

SAbR with each radiation treatment fraction delivered every other day

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Stereotactic radiation therapy

2005

Completed Phase 3

~240

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,683 Total Patients Enrolled

Dat Vo, MDPrincipal InvestigatorUT Southwestern Medical Center

Shahed Badiyan, MDPrincipal InvestigatorUT Southwestern Medical Center

2 Previous Clinical Trials

11 Total Patients Enrolled

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04786093 — Phase 2

$Non-Small Cell Lung Cancer Research Study Groups: Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) plus Durvalumab arm, Stereotactic Ablative Radiotherapy (SAbR) Arm plus Durvalumab arm$

Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04786093 — Phase 2

Durvalumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04786093 — 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 for this investigation open at the present?

"According to the details present on clinicaltrials.gov, enrollment for this trial is still open. After being initially posted August 10th 2021 and subsequently edited February 23rd 2022, patients are now eligible to apply."

Answered by AI

What is the major goal of this examination?

"This medical trial is designed to assess the Quality of Life (QoL) improvements following treatment. Secondary outcomes include Overall Response Rate, Progression Free Survival, and Out-of-Field Control which will be evaluated during a two year post-treatment period using Kaplan Meier methodologies."

Answered by AI

What is the aggregate amount of participants involved in this investigation?

"Affirmative. The clinical trial registry hosted on clinicaltrials.gov verifies that this medical study is actively recruiting participants, having first been posted on August 10th 2021 and last updated February 23rd 2022. At present, the research team needs to recruit 52 patients from a single site."

Answered by AI

Has there been precedent for employing Stereotactic radiation therapy in scientific research?

"Presently, there are 333 investigations of Stereotactic radiation therapy in progress. Of these studies, 52 have reached Phase 3. Notably, Cordoba, Texas is the primary site for this research; however a total of 12937 centres are running trials related to this method of treatment."

Answered by AI

Has the FDA given its stamp of approval to Stereotactic radiation therapy?

"Clinical data has provided a fair degree of assurance regarding the safety profile of Stereotactic Radiation Therapy, thus awarding it a score of 2. However, there is no existing data that confirms its efficacy as this trial is only in Phase 2."

Answered by AI

For what medical concerns is Stereotactic radiation therapy commonly employed?

"Stereotactic radiation therapy is frequently utilized to treat unresectable stage III non-small cell lung cancer. Moreover, it can be employed in treating advanced directives and metastatic ureteral urothelial carcinoma that has not been previously addressed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC

Shahed Badiyan 2021. "Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04786093.

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