Cancer types
Title of study
A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)
Version Number
Approval Date 
2, 9 June 2020
Short Title
ImmunoSABR
Study site
PACIFIC-4
Principle Investigator
L. Hendriks
Investigator Maastro
D. DeRuysscher
Sponsor
Astra Zeneca
Trial registry
Objectives 

– To assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS in patients with T1c to T3N0M0 NSCLC – To assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS in patients with Stage I/II NSCLC – To assess the efficacy of durvalumab monotherapy compared to placebo in terms of OS in patients with T1c to T3N0M0 NSCLC – To assess the efficacy of durvalumab monotherapy compared to placebo in terms of OS in patients with Stage I/II NSCLC – To further assess the efficacy of durvalumab monotherapy compared to placebo in terms of lung cancer-specific mortality – To further assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS24, TTP, TTDM, and PFS2 – To assess the PK of durvalumab
– To investigate the immunogenicity of durvalumab – To assess symptoms and health-related quality of life in patients treated with durvalumab monotherapy compared to placebo using the EORTC QLQ-C30

Primary Endpoint 

PFS using BICR assessments according to RECIST 1.1

Secondary Endpoints 

– OS – Lung cancer mortality – PFS24a, TTP, and TTDM using BICR assessments according to RECIST 1.1 – PFS2 using local assessment
– Concentration of durvalumab in blood such as peak concentration and trough, as data allow (sparse sampling) – Presence of ADA for durvalumab (confirmatory results: Positive or negative; titers) – EORTC QLQ-C30: Change in symptoms, functioning and global health status/quality of life