Spanish Real World Data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy (S-REAL Study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38962
• EU PAS number:
  EUPAS38961
• Study ID:
  38962
• Official title and acronym:
  Spanish Real World Data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy (S-REAL Study)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Lung Cancer represent approximately 13% of total cancer diagnoses worldwide. Stage III represents between 25-30% of NSCLC and the majority of them are unresectable. The SOC in unresectable patients was chemoradiotherapy consurrently if possible. The PACIFIC study is a phase III study to evaluate the efficacy and safety of durvalumab as a sequential therapy concurrent platinum-based chemo and thoracic RT. The study was positive for both primary endpoints PFS and OS. After that, it was decided to open an early acces program to provide acces to durvalumab for patients with locally advanced, unresectable NSCLC (stage III) who have not progressed following chemoradiation. S-Real study is a non-interventional, observational, multicentre, one-arm, non-comparative, and retrospective study.This observational study is based on the collection of data about the patients treated with Durvalumab after chemoradiotherapy in the real world. The study will include all patients who have participated in the Pacific study between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab. The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival. Secondary objectives are:To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate, to describe adverse events of special interests, to stimate time and sites of disease progression or relapse in metastatic setting, to describe details on durvalumab treatment, to describe demographic and clinical characteristics of stage III unresectable NSCLC patients treated with Durvalumab, to describe previous chemoradiotherapy strategy, to describe the baseline staging status, to further assess subsequent treatments pattern at the time of disease progression including duration and type of therapy, and to explore healthcare resource utilization while on durvalumab treatment.
• Study status:
  Finalised

Research institutions and networks

Institutions

Fundación Grupo Español de Cáncer de Pulmón (GECP)

Study timelines

Date when funding contract was signed

Actual: 14/02/2020

Study start date

Actual: 25/05/2020

Data analysis start date

Actual: 31/12/2020

Date of final study report

Planned: 31/12/2021

Actual: 20/09/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

Protocol_S-REAL_ENG_v.1.0_09Jan2020_FP.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

GEC-DUR-2020-01
ClinicalTrials.gov NCT04285866

Link to Clinicaltrials.gov