Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04597671
PHASE3

Durvalumab and Low-dose PCI vs Durvalumab and Observation in Radically Treated Patients With Stage III NSCLC (NVALT28)

Sponsor: Association NVALT Studies

View on ClinicalTrials.gov

Summary

This trial studies the combination of low-dose PCI with or without durvalumab in patients with radically treated stage III NSCLC. The hypothesis is that the incidence of brain metastases will be reduced from 30% to 15 % with durvalumab and to a maximum of 5% with the addition of low-dose PCI. This strategy would make brain metastases in stage III NSCLC history and this would improve QoL.

Official title: NVALT 28/ PRL01 Durvalumab and Low-dose Prophylactic Cranial Irradiation (PCI) Versus Durvalumab and Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer: A Phase III Randomized Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2021-12-06

Completion Date

2032-12

Last Updated

2025-01-29

Healthy Volunteers

No

Interventions

DRUG

Durvalumab

Durvalumab is used as standard of care

RADIATION

low-dose PCI

PCI will be given concurrently with durvalumab. PCI will be given to a dose of 15 Gy in 10 fractions

Locations (14)

ZGT

Almelo, Netherlands

AmsterdamUMC - location VUmc

Amsterdam, Netherlands

Radiotherapie Groep

Arnhem, Netherlands

Rijnstate

Arnhem, Netherlands

Gelderse Vallei

Ede, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

ZRTI

Flushing, Netherlands

UMCG

Groningen, Netherlands

Maastro

Maastricht, Netherlands

Canisius Wilhemina Ziekenhuis

Nijmegen, Netherlands

Radboud UMC

Nijmegen, Netherlands

ZorgSaam Ziekenhuis

Terneuzen, Netherlands

Maxima Medisch Centrum

Veldhoven, Netherlands

Zaans Medisch Centrum

Zaandam, Netherlands