Durvalumab vs Placebo With Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer Patients

Official Title

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-centre, International Study of Durvalumab With 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)

Summary:

This is a Phase III, randomized, placebo-controlled, double-blind, multi-centre study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS) assessed by BICR according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC

Secondary Outcome:

• Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC
• Overall Survival (OS)
• Lung cancer-specific mortality
• Peak Plasma Concentration (Cmax)
• Detection of ADA neutralising antibodies titers
• Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30
• Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1
• Time to progression (TTP) assessed by BICR according to RECIST 1.1
• Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1
• Time from randomisation to second progression (PFS2) as defined by local standard clinical practice
• Trough Concentration (Ctrough)
• Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of durvalumab with SoC SBRT compared to placebo with SoC SBRT

Patients who are to receive SoC SBRT as definitive treatment of stage I-II lymph node-negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to durvalumab or placebo. The primary objective of this study is to assess the efficacy of durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of OS.

View this trial on ClinicalTrials.gov