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

Sponsor
Association NVALT Studies
Study ID
NCT04597671
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab is used as standard of care
  • low-dose PCI — RADIATION
    PCI will be given concurrently with durvalumab. PCI will be given to a dose of 15 Gy in 10 fractions

Study Details

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.

Key Dates

Start date
Dec 6, 2021
Status verified
Jan 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2032

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm A
    Durvalumab with low-dose PCI
  • Active Comparator: Arm B
    Durvalumab with observation

Primary Outcome Measure

Reduction of incidence of brain metastases [ Time Frame: From randomisation until moment of discovery of brain metastases or latest at 24 months after randomization ]

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