Open Label, Multicenter, Real World Practice of Durvalumab in Lung Cancer (Imfinzi PMS)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Lung Cancer
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
Primary objective : To assess safety of Imfinzi for patients with NSCLC or SCLC 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 ...
Primary objective : To assess safety of Imfinzi for patients with NSCLC or SCLC 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 with NSCLC or SCLC treated with Imfinzi under the approved indication in Korea Outcome Measure: Progression free survival (PFS) Objective response rate (ORR) Duration of response (DoR)
Tracking Information
- NCT #
- NCT04068168
- Collaborators
- Not Provided
- Investigators
- Not Provided