NCT05206812

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	durvalumab	* durvalumab 1500 mg QD\* * Surgery within 1 to 8 weeks - 4 cycles of durvalumab 1500 mg/m2 (Day 1, Day 8)+cisplatin 80 mg/m2 (Day 1) q3wks -durvalumab 1500 mg q4wks (Maximum of 10 cycles)

Timeline

• Start date: 2022-09-01
• Primary completion: 2027-01-01
• Completion: 2028-07-01
• First posted: 2022-01-25
• Last updated: 2026-01-27

Locations

1 site across 1 country: South Korea