Phase II Study of Durvalumab ,Doxorubicin, and Ifosfamide in Pulmonary Sarcomatoid Carcinoma

Sponsor
Seoul National University Hospital
Study ID
NCT04224337
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Durvalumab + doxorubicin + ifosfamide — DRUG
    Durvalumab: 1500mg via IV infusion on day 1 Q3W for 4 cycles followed by durvalumab monotherapy 1500mg via IV infusion Q4W for up to a maximum 12 months Doxorubicin 20mg/m2 via IV infusion on day 1 to day 3 Q3W (up to 4 cycles) Ifosfamide: 1.5g/m2 (with mesna) via IV infusion on day 2 to day 4 Q3W (up to 4cycles)

Study Details

To evaluate the efficacy and safety of durvalumab in combination with doxorubicin and ifosfamide in patients with PSC.

Key Dates

Start date
Jun 11, 2020
Status verified
Dec 2025
Primary completion
Aug 14, 2023
Completion
May 7, 2025

Study Design

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

Arms

  • Experimental: Experimental
    Durvalumab + doxorubicin + ifosfamide

Primary Outcome Measure

Response rate (RR) [ Time Frame: 24 months ]

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