Efficacy and Safety Study of DURVALUMAB Maintenance in Patients With Stage III Non-Small Cell Lung Cancer
- Conditions
- Bronchial Cancer
- Registration Number
- NCT06564870
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
The aim of this study is to evaluate the real-life efficacy of durvalumab treatment in consolidation after radio-chemotherapy.
- 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
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Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- Age < 18 years.
- Refusal to participate
- Patients under legal protection (curatorship, guardianship, etc.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Real-life efficacy of durvalumab treatment in maintenance after chemoradiotherapy. 1 year progression-free survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU de Brest
🇫🇷Brest, France