Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-123
Prinicipal Investigator
Ma, Patrick
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
PrE0506
Title
DuRvalumab MEDI4730 with chEmotherapy as first line treAtment in advanced pleural Mesothelioma A phase 3 Randomised trial (DREAM3R)
Objective
The general aim of the trial is to determine the effectiveness of adding durvalumab to standard first line chemotherapy with cisplatin and pemetrexed in advanced malignant pleural mesothelioma.

The specific objectives (endpoints) of this trial are to determine:

Primary Objectives
1. Overall survival
Secondary Objectives
2.PFS (by mRECIST 1.1 for MPM and iRECIST)
3.Objective tumour response [(OTR) by mRECIST 1.1 for MPM and iRECIST]
4.Adverse events (CTCAE v5.0)
5.Health-related quality of life (HRQL, EORTC QLQ-C30, QLQ LC-29, EQ-5D-5L)
6.Healthcare resource use relative to outcomes (incremental cost-effectiveness)

Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center