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

Regional University Hospital Center (CHRU)

Status: Active, not recruiting

Conditions: Bronchial Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06564870

DURVABREIZH - 29BRC21.0199

Details and patient eligibility

About

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

Full 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)

Enrollment: 200 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.)