Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.

Sponsor
Fundación GECP
Study ID
NCT04285866
Status
Completed

Conditions

  • Small Cell Lung Cancer (SCLC)

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab after chemoradiotherapy

Study Details

This is a non-interventional, observational, multicentre, one-arm, non-comparative, and retrospective study. The study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival.

Key Dates

Start date
May 21, 2020
Status verified
Jun 2022
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
245 participants (actual)

Arms

  • Arm: Durvalumab Group
    Patients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From date of the first dose of durvalumab received (within the EAP) to the date of disease progression, death, or the end of follow-up, assessed up to 60 months ]

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