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Immunotherapy

Durvalumab for Non-Small Cell Lung Cancer

Q: Are recruitment efforts for this research study still ongoing?

The clinical trial in question is not recruiting patients at the moment, as reflected on clinicaltrials.gov. This particular trial was first posted on August 30th, 2019 and was last updated on July 5th, 2022. There are 2421 other trials that are actively recruiting patients.

Q: What are some other similar studies that have used Durvalumab?

A total of 337 studies, 51 of which are currently active, are being conducted to explore durvalumab's efficacy. The majority of these trials are based in Hat Yai, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>, but there are 12897 total locations running these tests.

Q: Can you provide some examples of how Durvalumab is typically employed?

Durvalumab can be used to treat patients with unresectable stage iii non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, metastatic ureter urothelial carcinoma, and those who have not yet undergone treatment.

Phase < 1

Waitlist Available

Led By Debora Bruno, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Must have anticipated life expectancy of at least 12 weeks

AJCC 8th Stage IIA-IIIC.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days following end of treatment

Awards & highlights

Study Summary

This trial is testing a new combination of treatments for lung cancer - durvalumab (a new drug) and proton beam therapy (a new type of radiation).

Eligible Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

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

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You are expected to live for at least 12 more weeks.

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You have stage IIA, IIB, IIC, or III cancer, as defined by the American Joint Committee on Cancer (AJCC).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days following end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days following end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days following end of 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

Therapeutic radiology procedure

Secondary outcome measures

Feasibility of intervention defined by number of participants receiving full course of RT treatment and minimum of two doses of Durvalumab

Number of participants with Adverse Events according to CTCAE v5.0

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 - 69 CGyE in 23 fractions followed by expansion cohort aExperimental Treatment2 Interventions

Proton based external beam radiation therapy with concurrent Durvalumab starting one week before RT. Radiation will follow dose escalation scheme: 69 CGyE in 23 fractions (3+3 participants, 3-6 total) Followed by expansion cohort at identified RP2 dose (12 participants)

Group II: Arm 1 - 60 CGyE in 20 fractionsExperimental Treatment2 Interventions

Proton based external beam radiation therapy with concurrent Durvalumab starting one week before RT. Radiation will follow dose escalation scheme: 60 CGyE in 20 fractions (3+3 participants, 3-6 total)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

448 Previous Clinical Trials

31,378 Total Patients Enrolled

Debora Bruno, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Tithi Biswas, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Frequently Asked Questions

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

Are recruitment efforts for this research study still ongoing?

"The clinical trial in question is not recruiting patients at the moment, as reflected on clinicaltrials.gov. This particular trial was first posted on August 30th, 2019 and was last updated on July 5th, 2022. There are 2421 other trials that are actively recruiting patients."

Answered by AI

What are some other similar studies that have used Durvalumab?

"A total of 337 studies, 51 of which are currently active, are being conducted to explore durvalumab's efficacy. The majority of these trials are based in Hat Yai, Texas, but there are 12897 total locations running these tests."

Answered by AI

Can you provide some examples of how Durvalumab is typically employed?

"Durvalumab can be used to treat patients with unresectable stage iii non-small cell lung cancer, metastatic ureter urothelial carcinoma, and those who have not yet undergone treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable NSCLC

2019. "Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03818776.