Spots Global Cancer Trial Database for Window of Opportunity Trial of Durvalumab (MEDI4736) to Identify Immune Dynamics in Operable Non-small Cell Lung Cancer (NSCLC) (MIRACLE)

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Trial Identification

Brief Title: Window of Opportunity Trial of Durvalumab (MEDI4736) to Identify Immune Dynamics in Operable Non-small Cell Lung Cancer (NSCLC) (MIRACLE)

Official Title: Window of Opportunity Trial of Durvalumab (MEDI4736) to Identify Immune Dynamics in Operable Non-small Cell Lung Cancer (NSCLC) (MIRACLE)

Study ID: NCT05206812

Conditions

Non Small Cell Lung Cancer

Interventions

durvalumab

Study Description

Brief Summary: This study is phase II, open label, clinical trial of durvalumab to identify immune dynamics in operable non-small cell lung cancer.

Detailed Description: In this study, the investigators plan to administer neoadjuvant durvalumab and adjuvant durvalumab to the operable NSCLC patients (resectable stage IIA\~IIIB) regardless of PD-L1 status. Durvalumab 1500mg IV will be administered once prior to surgery. Within 1-8 weeks after completion of durvalumab, patients will undergo surgery. Regardless of MRD status, patients will receive adjuvant treatment of durvalumab 1500mg IV q3 weeks with SoC platinum-based chemotherapy for a total of 4 cycles. \*\* Adjuvant chemotherapy will be based on standard of care treatment: navelbine 20mg/m2 (D1, 8) and cisplatin 80mg/m2 (D1) (q3w x 4 cycles). Thereafter, patients will be administered with adjuvant durvalumab 1500mg IV q4 weeks for 10 cycles