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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
Newly diagnosed, untreated, biopsy proven non-small cell lung cancer
Medically inoperable or patient refusal to surgery as defined by specific criteria
Must not have
Uncontrolled intercurrent illness including specific conditions
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I have been newly diagnosed with non-small cell lung cancer and have not received any treatment.
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I cannot undergo surgery for medical reasons or I have chosen not to.
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I am fully active or can carry out light work.
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My cancer is in the early stage (stage I) according to AJCC guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any uncontrolled illnesses.
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I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.
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I have previously been treated with PD1 or PD-L1 inhibitors or cancer vaccines.
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I have no lasting lung issues from past cancer treatments.
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I have had severe side effects from previous immunotherapy.
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I have been diagnosed with tuberculosis in the past.
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I have had cancer spread to the lining of my brain and spinal cord.
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I have seizures that are not controlled by medication.
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I need some help with my daily activities.
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My lung cancer has spread to other parts of my body or lymph nodes.
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I have had radiation therapy on the same lung area before.
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I have a specific lung condition.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Intralobar recurrence rates
Overall survival
Primary Tumor Control
+4 more
Other study objectives
Changes to circulating lymphocytes as indicators
germline mutations as indicators
nonsynonymous mutational load and intratumoral heterogeneity as indicators

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
370 Previous Clinical Trials
35,176 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,411 Previous Clinical Trials
289,123,055 Total Patients Enrolled
Percy Lee, MDPrincipal InvestigatorAssociate Professor
2 Previous Clinical Trials
150 Total Patients Enrolled
Ann Raldow, MDPrincipal InvestigatorAssociate Professor
1 Previous Clinical Trials
21 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
~1 spots leftby Jun 2025
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