RecruitingPhase 4NCT06908070

Chemoradiotherapy With Surgery Followed by Consolidation Durvalumab

ChemoRadiOtherapy With Surgery Followed by Consolidation Durvalumab for Initially Unresectable Stage III NSCLC (CROWD): a Phase IV Feasibility Trial

Sponsor

Idris Bahce

Enrollment

38 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

Non-Small Cell Lung Cancer (Stage III)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving patients with stage III non-small cell lung cancer (NSCLC) surgery followed by the immunotherapy drug durvalumab — after chemoradiation — leads to better outcomes than chemoradiation and durvalumab alone. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage III non-small cell lung cancer (excluding N3 disease) - You are planned for concurrent chemoradiation (platinum-based chemotherapy with 60 Gy radiation) followed by durvalumab - Your cancer has been confirmed by tissue biopsy **You may NOT be eligible if...** - Your cancer has spread to certain lymph node regions (N3) - You are not a candidate for concurrent chemoradiation - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGConsolidation 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