← Back to Search

PD-L1 Inhibitor

Durvalumab + SABR for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Percy Lee, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years at time of study entry

Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

Study Summary

This trial is testing a new drug, durvalumab, to see if it can help reduce the growth of lung cancer in combination with a type of radiation therapy called SABR. The trial will enroll 105 subjects who will be randomly assigned to receive either the combination therapy or SABR alone. Follow-up visits will be conducted to monitor subjects' health and collect blood samples to study the effects of the drug and radiation therapy.

Who is the study for?

This trial is for adults over 18 with newly diagnosed, untreated non-small cell lung cancer that's in stage I. They must be unable to undergo surgery or refuse it and have good organ function and performance status (able to carry out daily activities). Pregnant women, those on immunosuppressants, with certain other health conditions or previous treatments like PD-1/PD-L1 inhibitors are excluded.Check my eligibility

What is being tested?

The study tests durvalumab combined with Stereotactic Ablative Body Radiotherapy (SABR) against SABR alone in a randomized fashion. Initially, safety will be assessed in a small group before more participants are randomly assigned to either the combination therapy or just SABR.See study design

What are the potential side effects?

Durvalumab may cause immune-related side effects affecting different organs, infusion reactions similar to allergic responses, fatigue, and potential worsening of pre-existing autoimmune diseases. Radiation can lead to skin changes at the treatment site and fatigue.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am older than 18 years.

Select...

I am willing and able to follow the study's requirements, including treatments and visits.

Select...

I have been newly diagnosed with non-small cell lung cancer and have not received any treatment.

Select...

I cannot undergo surgery for medical reasons or I have chosen not to.

Select...

I am fully active or can carry out light work.

Select...

My cancer is in the early stage (stage I) according to AJCC guidelines.

Select...

My organs and bone marrow are functioning well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

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

Treatment Details

Study Objectives

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

Primary outcome measures

Phase I: The number and severity of study participants' treatment-related adverse events as assessed by CTCAE v4.0.

Phase II: Median Progression-Free Survival

Secondary outcome measures

Intralobar recurrence rates

Overall survival

Primary Tumor Control

+4 more

Other outcome measures

Changes to circulating lymphocytes as indicators

germline mutations as indicators

nonsynonymous mutational load and intratumoral heterogeneity as indicators

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Regimen A: Phase IIExperimental Treatment2 Interventions

The intervention will be looking at radiotherapy + drug Durvalumab (MEDI 4736)

Group II: Regimen A: Phase IExperimental Treatment2 Interventions

The intervention will be looking at radiotherapy + drug Durvalumab (MEDI 4736)

Group III: Regimen B: Phase IIActive Control1 Intervention

Radiotherapy alone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiotherapy

2017

Completed Phase 3

~2610

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,032 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,259 Previous Clinical Trials

288,593,884 Total Patients Enrolled

Percy Lee, MDPrincipal InvestigatorAssociate Professor

2 Previous Clinical Trials

150 Total Patients Enrolled

Media Library

Durvalumab (MEDI 4736) (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03148327 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: Regimen A: Phase II, Regimen A: Phase I, Regimen B: Phase II

Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab (MEDI 4736) Highlights & Side Effects. Trial Name: NCT03148327 — Phase 1 & 2

Durvalumab (MEDI 4736) (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03148327 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people with the qualifying condition enroll in this research program?

"Unfortunately, this trial is no longer searching for new patients. The study was first posted on October 11th, 2017 and updated for the last time on November 14th, 2022. However, there are 1394 other studies actively recruiting participants who have carcinoma and non-small-cell lung cancer as well as 338 additional studies involving Durvalumab (MEDI 4736)."

Answered by AI

What are the investigators of this study hoping to prove?

"The primary goal of this 4 month study will be to assess Phase II Median Progression-Free Survival. Additionally, researchers will also evaluate the Secondary outcomes of Primary Tumor Control, Overall survival, and rates of grade 3 or higher non-hematological toxicities."

Answered by AI

How is Durvalumab (MEDI 4736) typically employed?

"Durvalumab (MEDI 4736) is most often used to treat unresectable stage iii non-small cell lung cancer. However, it has also been shown to effectively target other conditions such as previously untreated, metastatic ureter urothelial carcinoma and advance directives."

Answered by AI

Does MEDI 4736 have a clinical trial history?

"There are 338 clinical trials globally that are currently testing Durvalumab (MEDI 4736), with the majority of these in Phase 3. 51 out of the total 338 trials are based in Cordoba, Texas; however, there are 12905 locations conducting research on this medication."

Answered by AI

How many people can take part in this research project?

"This clinical trial is no longer enrolling patients. The study was posted on October 11th, 2017 and last edited on November 14th, 2022; however, there are presently 1394 trials actively enrolling patients with carcinoma, non-small-cell lung and 338 studies for Durvalumab (MEDI 4736) actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Astra Zeneca (Immuno Stereotactic Ablative Body Radiotherapy) ISABR Study: Randomized Phase I/II Study of Stereotactic Body Radiotherapy

2017. "Astra Zeneca (Immuno Stereotactic Ablative Body Radiotherapy) ISABR Study: Randomized Phase I/II Study of Stereotactic Body Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03148327.

All > Non Small Cell Lung Cancer