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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

Must not have

Patients with untreated brain metastases

Immunosuppressive medications including, but not limited to, systemic corticosteroids at doses exceeding 10 mg/day of prednisone or equivalent, methotrexate, azathioprine, and tumor necrosis factor-α blockers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post-treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases that have not been treated.

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I am not taking high doses of steroids or medications that weaken my immune system.

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I am taking or have taken certain medications.

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I have not had major surgery in the last 28 days.

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I have received an organ transplant from another person.

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I do not have any uncontrolled illnesses.

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I am not currently on any cancer treatments like chemotherapy.

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I have received at least two treatments for my advanced lung cancer.

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My cancer has spread and is 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of Life Scores

Secondary study objectives

Instances of Toxicity

Local control (LC)

Out-of-field control

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 4

~3880

Stereotactic radiation therapy

2005

Completed Phase 3

~240

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,089 Previous Clinical Trials

1,059,631 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

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