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NCT Number: NCT06564870

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Brest

Brest, 29609, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. Real-life efficacy of durvalumab treatment in maintenance after chemoradiotherapy.

    Time frame: 1 year

    progression-free survival

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: DURVABREIZH

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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