Chemoradiation With Durvalumab Followed by Durvalumab Maintenance for Limited Disease Small Cell Lung Cancer

Sponsor
Samsung Medical Center
Study ID
NCT03585998
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Concurrent radiotherapy Maintenance therapy

Study Details

This is a single arm Phase II study, in which 4 cycles of chemotherapy (Etoposide and Cisplatin) and durvalumab with thoracic radiotherapy (52.2Gy, 2.1Gy/Fx) start at the 3rd cycle of chemotherapy and durvalumab for limited disease-small cell lung cancer. Four weeks after completion of concurrent chemoradiation therapy, patients will receive durvalumab consolidation monotherapy every 4 weeks until progression of disease or unacceptable toxicity up to the maximum duration of 2 years since enrollment.

Key Dates

Start date
Jun 19, 2018
Status verified
Feb 2020
Primary completion
Jun 19, 2021
Completion
Dec 19, 2021

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study arm
    Concurrent radiotherapy with chemotherapy (Etoposide/Cisplatin) with durvalumab, and followed by consolidation durvalumab

Primary Outcome Measure

Progression free survival [ Time Frame: 1 year ]

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