Chemoradiotherapy With Surgery Followed by Consolidation Durvalumab

Sponsor
Idris Bahce
Study ID
NCT06908070
Phase
PHASE4
Status
Recruiting
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Conditions

  • Non-small Cell Lung Cancer Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Consolidation durvalumab — DRUG
    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

Study Details

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.

Key Dates

Start date
Dec 17, 2024
Status verified
Apr 2025
Primary completion
Dec 17, 2026
Completion
Dec 17, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemoradiotherapy plus surgery and immunotherapy
    Chemoradiotherapy followed by surgery and consolidation durvalumab

Primary Outcome Measure

The rates of severe surgical morbidity and mortality [ Time Frame: Within 90-days of surgery ]

Central Contacts

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