Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

712 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-30

Study Completion Date

2024-12-27

Brief Summary

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The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.

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Detailed Description

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Primary objective : To assess safety of Imfinzi for patients treated with Imfinzi under the approved indication in Korea

Outcome Measure:

* Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE))
* Dose interruptions
* Duration of treatment
* Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients treated with Imfinzi under the approved indication in Korea

Outcome Measure:

* Progression free survival (PFS)
* Objective response rate (ORR)
* Duration of response (DoR)

Conditions

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Lung Cancer, Biliary Tract Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Eligible for Imfinzi treatment according to the approved label
* Provision of signed and dated written informed consent by the patient or legally acceptable representative