Stereotactic radiation therapy for Non-Small Cell Lung Cancer

University of Texas Southwestern Medical Center, Dallas, TX
Non-Small Cell Lung CancerStereotactic radiation therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 3 years

1 year post-treatment
Local control (LC)
Out-of-field control
12 weeks from randomization
overall response rate (ORR)
2 years post-treatment
Instances of Toxicity
Overall Survival
Progression free survival (PFS)
Quality of Life Scores
3 years
Progression free survival
improved Quality of life

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Stereotactic Ablative Radiotherapy (SAbR) Arm plus Durvalumab arm
1 of 2
Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) plus Durvalum...
1 of 2

Active Control

Experimental Treatment

52 Total Participants · 2 Treatment Groups

Primary Treatment: Stereotactic radiation therapy · No Placebo Group · Phase 2

Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) plus Durvalumab armExperimental Group · 2 Interventions: Durvalumab, Stereotactic radiation therapy · Intervention Types: Drug, Radiation
Stereotactic Ablative Radiotherapy (SAbR) Arm plus Durvalumab armActiveComparator Group · 2 Interventions: Durvalumab, Stereotactic radiation therapy · Intervention Types: Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Stereotactic radiation therapy
2005
Completed Phase 3
~240

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
971 Previous Clinical Trials
1,115,759 Total Patients Enrolled
Dat Vo, MDPrincipal InvestigatorUT Southwestern Medical Center

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least six more months.
You have either been diagnosed with advanced cancer that has spread to other parts of your body (de novo metastatic disease) or your cancer has returned after previous treatment (recurrent disease).
If you have cancer that has spread to important bones in your legs or spine, you may need surgery to support those bones.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.