PACIFIC-Real World
Research type
Research Study
Full title
First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy
IRAS ID
268317
Contact name
Fiona McDonald
Contact email
Sponsor organisation
Astra Zeneca
Clinicaltrials.gov Identifier
NCT03798535, ClinicalTrials.gov Identifier
Duration of Study in the UK
5 years, 4 months, 1 days
Research summary
This is a multinational, multicentre observational study that will be conducted in 8 European countries along with Israel and Australia.
Based on the outcomes from PACIFIC trial, Astra Zeneca opened a prospective, open-label clinical early access programme (EAP) and provide ethical access to durvalumab (IMFINZI) for patients who have completed chemoradiotherapy (CRT) with locally advanced unresectable stage Ill non-small cell lung cancer (NSCLC) and who have an unmet clinical need which cannot be treated with approved with commercially available drugs.
PACIFIC-Real World study is designed to enrol patients who have received at least 1 dose of durvalumab within one of the EAPs between Sep 2017 up to end of EAP enrolment or marketing authorization (MA) plus a max. of 3 months. Country participation and patient recruitment to the study will be when the EAP enrolment period has closed within that country (in the UK the programme is closed on 1st May 2019).
PACIFIC R study aims to provide the first real-world data on the effectiveness of durvalumab in this NSCLC patient population treated outside a clinical trial. The study will be conducted as a 4-5 retrospective chart abstractions of secondary data at specified intervals up to 5 years after the first dose of durvalumab. The study does not require any change to treatments beyond the normal care, so there are no physical risks associated with participation. Detailed information of the study will be provided to patients and those who voluntarily agree for their data to be collected and analysed, in accordance with local requirements, will sign an informed consent form (ICF) before any study-related activity. Patient’s personal information will be kept completely private, no matter which county it goes to, even if that country does not have the same level of protection for personal information as in the UK.Lay summary of study results: The PACIFIC-R study provides the first real-world evidence on the use of durvalumab in patients with unresectable Stage III NSCLC (Non-Small Cell Lung Cancer) on the basis of a population of more than 1000 patients enrolled across 10 countries. The final DE (Data Extraction) of the study provides long-term effectiveness data with a median follow-up of more than 60 months.
The study demonstrated that effectiveness of durvalumab in real-world settings is broadly consistent with outcomes from the PACIFIC trial. As expected, PFS (Progression-Free Survival) and OS (Overall Survival) were higher among patients who received cCRT (Concurrent Chemoradiotherapy), patients with PD-L1(Programmed Cell Death-Ligand-1) expression on ≥ 1% of TC (Tumour Cell), and patients diagnosed with non-squamous histological subtype. Nevertheless, favourable outcomes were still observed among patients who received sCRT (Sequential chemoradiotherapy), patients with PD-L1(Programmed Cell Death-Ligand-1) expression on < 1% of TC (Tumour Cell), and those with squamous NSCLC (Non-Small Cell Lung Cancer) .
PACIFIC-R study did not reveal any new safety signals compared to previously reported data and supports the tolerable safety profile of durvalumab in this setting. Overall, the findings in the PACIFIC-R study support durvalumab consolidation after CRT (Chemoradiotherapy) as the global standard of care for patients with unresectable Stage III NSCLC (Non-Small Cell Lung Cancer).REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0243
Date of REC Opinion
2 Sep 2019
REC opinion
Favourable Opinion