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

Sponsor
Yonsei University
Study ID
NCT05206812
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • durvalumab — DRUG
    * 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)

Study Details

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

Key Dates

Start date
Sep 1, 2022
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jul 31, 2028

Study Design

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

Arms

  • Experimental: durvalumab
    The operable non-small cell lung carcinoma patients (resectable stage IIA\~IIIB)

Primary Outcome Measure

Major pathologic response [ Time Frame: Right after the surgery ]

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