Efficacy and Safety Study of DURVALUMAB Maintenance in Patients With Stage III Non-Small Cell Lung Cancer (DURVABREIZH)

August 19, 2024 updated by: University Hospital, Brest

Retrospective Observational Study of the Efficacy and Safety of DURVALUMAB Maintenance Therapy in Patients With Stage III Non-Small Cell Lung Cancer (DURVABREIZH)

The aim of this study is to evaluate the real-life efficacy of durvalumab treatment in consolidation after radio-chemotherapy.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Immune checkpoint inhibitors (ICIs) such as anti-PD-1/PD-L1 have revolutionized the field of immuno-oncology, inducing significant and durable responses in patients with all types of tumor, and in particular advanced stage (II-IV) non-small cell lung cancer (NSCLC). The use of durvalumab in consolidation, after radiochemotherapy, in locally advanced NSCLC has significantly improved progression-free survival and overall survival (see PACIFIC trial). Durvalumab now has marketing authorization for this indication, in cases of PD-L1≥1% overexpression on tumor cells.

However, 50% of patients experience tumor progression at 1 year, and there is currently no biomarker (clinical, biological or radiological) predictive of tumor response to durvalumab in consolidation.

Elucidating the determinants of response and resistance to treatment, as well as predicting severe immune-mediated adverse events, are essential to improving patient outcomes and developing new therapeutic strategies

Translated with DeepL.com (free version)

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with unresectable locally advanced non-small cell lung cancer (stages IIIA, IIIB and IIIC) who have responded to or are stable after concurrent or sequential platinum-based radiochemotherapy and have received maintenance durvalumab therapy

Description

Inclusion Criteria:

  • Patients with unresectable locally advanced non-small-cell lung cancer (stages II, IIIA, IIIB and IIIC) responding to or stable after concomitant or sequential platinum-based radiochemotherapy and having received durvalumab consolidation therapy
  • Minimum radiotherapy dose of 54 Gy to 66 Gy
  • Age greater than or equal to 18 years
  • WHO 0-1
  • Non-opposition of living patients formulated

Exclusion Criteria:

  • Age < 18 years.
  • Refusal to participate
  • Patients under legal protection (curatorship, guardianship, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-life efficacy of durvalumab treatment in maintenance after chemoradiotherapy.
Time Frame: 1 year
progression-free survival
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DURVABREIZH - 29BRC21.0199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available after the publication of result and ending five years maximum following the last visit of the last patient

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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