Chemoradiotherapy With Surgery Followed by Consolidation Durvalumab
NCT06908070 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2025-04-03
Summary
Lung cancer presents a significant treatment challenge, particularly in the heterogeneous stage III NSCLC patient population. While chemotherapy combined with high-dose radiotherapy (60 Gy in 30 fractions of 2 Gy once daily) is currently the recommended approach for unresectable stage III cases, it is associated with significant rates of locoregional and distant failures. Notably, the introduction of durvalumab consolidation therapy after chemoradiotherapy (CRT), as demonstrated in the PACIFIC study, has shown improved overall survival, primarily attributed to enhanced distant control. This improvement prompts further interest in investigating whether further improvements in locoregional control can lead to improved survival for patients. The present study aims to evaluate the feasibility of post-CRT surgery in patients with initially considered unresectable stage III (non-N3) NSCLC.
Conditions
- Non-small Cell Lung Cancer Stage III
Interventions
- DRUG
-
Consolidation durvalumab
Patients with initially unresectable stage III NSCLC will undergo surgery after chemoradiotherapy completion when the tumor is deemed resectable by the thoracic oncology tumor board and will then receive durvalumab
Sponsors & Collaborators
-
Idris Bahce
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-17
- Primary Completion
- 2026-12-17
- Completion
- 2028-12-17
Countries
- Netherlands
Study Locations
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