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

NCT04597671 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-01-29

No results posted yet for this study

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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

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

Sponsors & Collaborators

  • Association NVALT Studies

    lead OTHER

Principal Investigators

  • Dirk De Ruysscher, MD PhD · Maastricht University/ Maastro clinic

  • Lizza Hendriks, MD PhD · Maastricht UMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2028-12-31
Completion
2032-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597671 on ClinicalTrials.gov